FDA Archives - Green Market Report

Adam JacksonAugust 10, 2022
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7min50

Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE) posted positive results as the company continues to further its research and development goals — with signs of a FDA approval looming in the distance. The cannabis biotech company reported financial results for the second quarter ending June 30, 2021,

Research and development expenses were $5.4 million for the second quarter of 2022, the company said, including stock-based compensation of $0.5 million. General and administrative expenses were $3.7 million in the second quarter this year, including stock-based compensation expense of $0.6 million. As an emerging biotech company, Zynerba does not have revenue at this time as it develops drugs.

The company said that it has continued to focus resources toward developing treatment for two orphan neuropsychiatric disorders, Fragile X syndrome and 22q Deletion Syndrome.

“During the second quarter, we were pleased to announce positive top-line results from our Phase 2 trial of Zygel in patients with 22q,” said CEO Armando Anido. “In addition to further progressing 22q, we are focused on completing the Phase 3 RECONNECT trial for children and adolescents with Fragile X syndrome, with top-line results expected in the second half of 2023.”

With a cash runway extending past expected availability of top-line results from our RECONNECT trial, we remain well-positioned on achieving our goal of bringing the first pharmaceutical product indicated for the treatment of behavioral symptoms of Fragile X syndrome to market.”

This echoes Zynerba’s belief that the results from RECONNECT, if positive, will be sufficient to support the submission of a New Drug Application (NDA) for Zygel in patients with Fragile X syndrome.

The company also said it plans to meet with the U.S. Food and Drug Administration (FDA) to discuss the data and the regulatory path forward for its open label Phase 2 INSPIRE trial of Zygel in children and adolescents with 22q Deletion Syndrome — also called DiGeorge syndrome, a chromosomal disorder with no known cure that results in poor development of several body systems.

The company said it plans to move forward in 22q as an orphan indication and has previously received orphan drug designation from the FDA for cannabidiol, the active ingredient in Zygel, for the treatment of 22q.

While data from the company’s ASD clinical development program to date are compelling, given the difficult financing market, the company has deferred the start of the Phase 3 development program in ASD as it has prioritized its resources on FXS and 22q in the near term.

Net loss for the second quarter of 2022 was $9.9 million, with basic and diluted loss per share of $0.24 cents. Cash and cash equivalents were $62.5 million, versus $67.8 million as of December 31, 2021.

In May, the company entered into a Controlled Equity Offering Sales Agreement — with Cantor Fitzgerald & Co., Canaccord Genuity, LLC, H.C. Wainwright & Co. LLC and Ladenburg Thalmann & Co. Inc. as sales agents — in which the company may sell, from time to time, up to $75 million of its common stock.

Zynerba then sold and issued 488,892 shares of its common stock in the second quarter under the agreement in the open market — resulting in gross proceeds of $0.9 million and net proceeds of $0.8 million, after deducting commissions and offering expenses.

After that, from July 1, 2022 through August 8, 2022, the company sold and issued 1,469,714 shares of its common stock under the agreement in the open market resulting in gross proceeds of $1.8 million, and net proceeds of $1.6 after deducting commissions and offering expenses.

Zynerba also struck an equity purchase deal last month for up to $20 million with Chicago-based firm Lincoln Park Capital Fund (LPC).

Lincoln Park Capital is expected to provide financial flexibility and is aligned with Zynerba’s long-term strategy for value creation, the company said.

Zynerba said it plans to use any net proceeds from the sale of its common stock to LPC for working capital and general corporate purposes, including research and development expenses and capital expenditures.

Management believes that the Company’s cash and cash equivalents are sufficient to fund operations and capital requirements through the end of 2023 or into early 2024, after the expected availability of top-line results from its confirmatory pivotal Phase 3 RECONNECT trial of Zygel in patients with FXS.


Dave HodesJuly 28, 2022
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9min320

Among the four Food and Drug Administration (FDA) pathways for developing new drugs faster are Fast Track, created in 1997, designed to expedite the review of drugs to treat serious conditions and fill an unmet medical need; and Breakthrough Therapy, created by the FDA in July 2012, a process designed to expedite the development and review of drugs that are intended to treat a serious condition, where “preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).”

There have been no psychedelic compounds listed on the FDA’s fast-track approval list (but oxycodone made the list in 2016), and just a few listed on the FDA’s breakthrough therapy list, such as the Compass Pathways’ (NASDAQ: CMPS) psilocybin therapy for treatment-resistant depression in October 2018, and the Janssen Pharmaceuticals’ Spravato in March 2019.

All four FDA expedited drug development pathways are designed to overcome the problems of the long process of drug development, in part fueled by the AIDS epidemic when researchers had called for quicker review and development of drugs by the FDA.

In the 1960s and 1970s, clinical development of a new compound through marketing approval took respectively 7.9 years and 8.2 years, on average, according to one study.

Real World Evidence

While the development process is designed to ensure efficacy and safety, there is a new and growing acceptance of a new process of advancing drug development based on the rapid accumulation of data, which may soon be working with the randomized clinical trial (RCT) process—it’s called real-world evidence, or RWE.

The FDA promoted the use of RWE for a faster pathway to developing Covid vaccines beginning in September 2021 in a process that continues today.

Another example of RWE effectiveness was demonstrated in a recent study of the outcomes of ketamine from patients treated in 178 participating independent community ketamine practices across the U.S.—a setting that offers significantly different outcomes compared to patients in randomized trials.

The outcomes were measured on 9,016 outpatients with symptoms of depression who received ketamine intravenous therapy (KIT) between 2016 and 2020.

It was the largest published analysis to date examining the real-world effectiveness of a standard KIT induction protocol for depression using data from patients treated at community clinics across the United States.

One of the critical findings of the study is that a richer data set from RWE can form the basis of predictive models that directly inform clinical care. One example is how data about how medications, taken daily or as adjuncts to KIT, can modify the response. “More broadly, point of care data collection and personal sensing streams (e.g. actigraphy, or “wearables”) can establish links between self-report measures and functional health outcomes,” the study reported.

So RWE can help inform clinical care going forward. But what is the relationship now between real-world evidence and clinical trials?

The outcomes of RWE today usually get a lower credibility assignation by researchers working on RCTs. But RWE research is a practice that does not need to be done like a random clinical trial research for it to be reliable, according to another study.

Some of the advantages of RWE include less time and cost compared to RCT; research that can’t be done with RCT, such as safe research on high-risk groups; rapid access and easier information and data retrieval; and more.

The FDA sees the advantages and published draft guidance for working with RWE in September 2021. According to the FDA, RWE can be generated by different study designs or analyses from randomized trials, including large simple trials, pragmatic trials, and observational studies—all built on such real-world data (RWD) as electronic health records, product and disease registries, patient-generated data including in-home use settings, and data gathered from other sources that can inform on health status, such as mobile devices.

As more RWD is collected, RWE is being gradually expanded, with a developing need to be more structured and use the new silos of health data being generated every day. RWE and RCT research are not in a mutually competitive relationship, a study noted. “Presently, RWE research cannot substitute RCT research. However, RCT research, bestowed the highest reliability, and RWE research, perceived to reflect the actual clinical aspect, can be proven to share a mutually supplementary relationship to become the most powerful resource in evidence-based medicine.”

Today, as spelled out in a “Forbes” article by Dr. Dan Riskin, the founder of Verantos, health systems, insurers, and pharmaceutical firms have all created RWE divisions. Insurance companies use RWE to analyze whether high-cost therapies provide sufficient benefit.

But there are still many questions to answer. For example, would an identical RCT trial and an RWE study reach the same conclusions? The FDA is looking into that in more detail, hoping to make RWEs more valid by conducting additional RCT/RWE trial emulations to add to the ten already done.

Meanwhile, progress on RWEs for psychedelics research continues. Compass Pathways is searching for an RWE manager as it further investigates the process. And one company that hopes to make headway in using RWE for developing psychedelics is Albert Labs in British Columbia. “RWE studies are a much faster and vastly less expensive way to conduct and take medicine through regulatory approval to commercialization compared to RCT trials, as evidenced in bringing Covid 19 vaccines to market,” said Malcolm Barratt-Johnson, chief medical officer for Albert Labs in a blog featured on their website.


Joanne CachaperoJuly 19, 2022
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7min90

Cannabis research firm Brightfield Group released its CBD: FDA Impact and the Path Forward/ 2022 Mid-Year US CBD Report, which found that growth in the CBD industry is “heavily dependent” on Food and Drug Administration (FDA) regulation, though there has been little progress on federal regulation for cannabidiol (CBD) since provisions removing hemp and hemp derivatives from prohibition were passed in the Farm Act of 2018. 

“If federal regulation were to be implemented by 2024, sales are expected to reach $11.0 billion by 2027, driven by accelerated growth of ingestible products like capsules and gummies as well as increased acceptance by mainstream retailers,” the Brightside report said. “Without such guidance, the CBD market is expected to remain decidedly lower.”

CBD Needs FDA

Currently, the U.S. CBD market is expected to reach $5 billion by 2022, according to Brightside. The report then offered two scenarios – projections with FDA guidance in place by 2024, or without. Their analysis predicted more than $4 billion in growth for the CBD industry by 2027, to $11 billion with the implementation of a regulatory scheme. However, without regulation, the report predicted relatively stagnant growth over the same time period to just over $6 billion. 

Lack of FDA guidance, Brightside pointed out, presented challenges for CBD industry businesses by allowing a market environment with “a shifting product mix and competition from other hemp-derived cannabinoids, though price compression has begun to subside, and the industry is increasingly attracting attention from large firms.”

“While waiting for increased oversight, companies have been seeking to define CBD’s place in the wider wellness landscape and using tactics like creating non-CBD products that can be sold through mainstream outlets and partnering with retailers who do not sell CBD to increase distribution and reach a novel base of consumers,” the report surmised.

Charlotte’s Web CBD Gummies

Brightside said CBD product companies Charlotte’s Web (OTC: CWBHF) and Your CBD Store (SunMed) were the two top leaders in company shares for the second year in a row. Charlotte’s Web saw the largest portion of industry online sales and was third in brick-and-mortar sales behind Your CBD Store (SunMed) and American Shaman. Companies that saw significant gains in Q1 2022 included High Tide and Heavenly Rx/Simply Better Brands. 

Grocery store sales of CBD products grew 18 percent since 2021, with $131 million in sales predicted for 2022. Brightside called grocery companies “risk averse” in regards to CBD products, resulting in marketing challenges for ingestible CBD products. Topicals will account for more than 41 percent of grocery store CBD product sales in 2022, with tinctures a distant second place at just over 19 percent. With FDA guidance, the report said, the ingestible CBD product market was set to boom.

Hope Fades

Pundits and industry experts are not hopeful for any federal regulations to come from the agency any time soon. Though four years have passed since the hemp provisions were approved in the Farm Bill, only one CBD-based pharmaceutical application has been approved by the FDA; Epidiolex, which was developed to treat seizures associated with a severe form of pediatric epilepsy. 

The FDA has said there is not enough data or research on CBD (or other cannabinoids) to allow comprehensive guidance for the industry. The COVID-19 pandemic also apparently slowed progress for the agency, as it prioritized vaccine approval over the last two years. 

An open day-long meeting in mid-June was held by the Science Board to the FDA to discuss the challenges to evaluating cannabinoids as dietary supplements or food ingredients, as well as safety reviews and concerns regarding toxicity possibly associated with consistent consumption of large amounts of CBD. The agency claims concerns are based on data gathered during the approval of Epidiolex. CBD industry leaders said the meeting provided only more delaying tactics from the FDA. 

In February, the appointment of new FDA Commissioner Robert M. Califf, M.D., gave attorney Blair Gue of Rogoway Law, a glimmer of hope for progress. Comments from Califf, though, were nonspecific regarding when FDA guidance on CBD may be forthcoming. Gue pointed out that continued pressure on the agency was needed from CBD industry companies. 

“Though Commissioner Califf could not provide a plan or timeline for the adoption of hemp or CBD regulations, he did express a strong desire to work with Congress on the subject moving forward.  Given Commissioner Califf’s comments about his willingness and desire to make real progress on the FDA’s industrial hemp product and derivative regulations, now is the time for the industrial hemp community to apply pressure to ensure that he actually does so,” she said. 


Debra BorchardtJune 24, 2022
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9min870

The Food & Drug Administration (FDA) decided to ban the popular vape product Juul and issued a marketing denial orders (MDOs) to JUUL Labs Inc. for all of its products currently marketed in the United States. That’s a long-winded way of saying the products are now banned. The company must stop selling and distributing these products. The ban doesn’t mean that people who continue to use Juuls or have them in their possession will get into trouble, the product just can’t be sold. 

In addition, those currently on the U.S. market must be removed, or risk enforcement action. The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol-flavored pods at nicotine concentrations of 5.0% and 3.0%. 

“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf, M.D. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”

What trigged the FDA response was the company’s lack of data regarding the toxicological profile of the products. “In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.”

Cannabis Industry Worries

Vaping products in the cannabis industry are hugely popular, so the ban has attracted a great deal of attention among producers. Seattle-based data-analytics firm Headset recently reported that vapes were the second-largest category by revenue behind flower in the U.S. cannabis market during 2020 and 2021. The category logged nearly $2.6 billion in retail sales across six adult-use markets last year. Vape pens are also growing with sales rising 28% in 2021. Despite the sustainability issues, disposable vapes are proving to be very popular as well growing by 64%. Likely because disposable vape products tend to be cheaper. 

Arun Kurichety, chief operating officer and general counsel of Petalfast said, “ While the FDA’s decision to prohibit Juul from marketing its products in the US does not directly impact the cannabis industry, it suggests we may continue to expect scrutiny on all vaping products — nicotine and cannabis alike. For licensed businesses in the highly regulated cannabis industry, this shouldn’t be huge news. Rather than prohibition, this further highlights the need for consumer education regarding the risks of obtaining vape products in the illicit markets where product testing for safety is non-existent.”

E-cigarettes were originally hailed as an effective way for nicotine-addicted consumers to inhale with fewer terrible side effects. Tobacco companies all created versions for their tobacco-smoking customers with limited success. Yet, when Juul began marketing cotton candy flavored nicotine vapes, teens and young adults swarmed the products. Instead of helping already addicted adults, it created a whole new generation of Juul-addicted consumers. Parents complained and the FDA jumped in to address the situation. At first, it was just a clamp down on the flavors, but now it is banning the entire product line. 

Cannabis vapes also proved to be a nice option for consumers who didn’t want to smoke regular flower. Cannabis vapes were discreet, easy to carry, and didn’t create the distinct smell that burned flower did. They could be expensive, but cannabis consumers were willing to spend money for the convenience of being able to pop a vape in their pocket and ramble on. 

Arnaud Dumas de Rauly, CEO and co-founder of the Blinc Group said, “If the FDA took the time to look at the science surrounding vaping instead of having knee jerk reactions to statistics over youth consumption, they would see that vaping has been beneficial to countless individuals looking to quit smoking. For years, the European markets have embraced vape as such a necessary tool for the cessation of smoking that they offer health insurance breaks to those who vape.”

He went on to add, “If you look down the road to what this decision could mean for the cannabis vape industry, the federal illegality of cannabis will keep the space safe for now since the FDA is unwilling to regulate the industry while it remains a schedule one drug. However, this doesn’t mean that will be the case forever. I would hope when that time comes that the FDA will recognize that vape is considered one of the safest consumption methods, particularly for medical patients who are looking for the purest stream of cannabinoids and terpenes, and the absence of combustion means less hazardous substances and it’s easier on the lungs.”

A Post Juul World

One company that the trouble has already impacted in the Juul market is Greenlane (NASDAQ: GNLN). At one point in 2019, Greenlane was selling almost $50 million worth of Juul products. With the first ban on flavored products, sales fell over 30% to $33 million in 2020. Just this week, Greenlane noted that it was selling off assets in order to generate cash. The company has been weaning itself off its Juul dependence, but $50 million is a big number to make up elsewhere. 

In Closing

Juul has said it will appeal the ban and try to keep its products on the shelves while it fights the ban. Cannabis vapes may luck out purely due to the fact that the FDA can’t decide what to do about the federally illegal product.  Since the FDA can’t seem to make a decision on CBD products, tackling cannabis vape pens seems unlikely. Cannabis consumers haven’t been complaining about the product as evidenced by the growing sales. Like Dumas noted, the FDA was mostly reacting to angry parents of Juul-addicted teens. In the cannabis industry, not many people are complaining and that seems to have kept the product off the radar for now.


Debra BorchardtMay 9, 2022
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7min290

Last week, the Food & Drug Administration (FDA) sent out warning letters to five cannabidiol (CBD) companies for Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products.

“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” said FDA Principal Deputy Commissioner Janet Woodcock, M.D. “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.”

The companies receiving the letters were  Kingdom Harvest, Delta 8 Hemp, ATLRx Inc., BioMD Plus and M Six Labs Inc. The FDA reviewed all of the company’s websites and said the following:

The claims on your website and social media accounts establish that your products, some of which are available in multiple varieties are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d).

The FDA also zeroed in on the Delta-8 aspects saying:

FDA has also observed a proliferation of products containing another cannabinoid, Delta-8 THC, and has recently expressed serious concerns about products containing Delta-8 THC that include: 1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put the public health at risk; 2) FDA has received adverse event reports involving Delta-8 THC containing products; 3) Delta-8 THC has psychoactive and intoxicating effects; 4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace; and 5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children. See https://www.fda.gov/consumers/consumer-updates/5-things-know-about-delta-8-tetrahydrocannabinol-delta-8-thc. This letter is to inform you that your firm markets Delta-8 THC-containing products, and Delta-8 THC may pose a serious health risk to consumers.

The FDA also took issue with bringing “products into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll).”

Mostly the FDA was concerned with companies making unsubstantiated claims about the products.

COVID Claims

The FDA noted that the Kingdom Harvest website said, “Studies Show Our Whole-Spectrum Extract Utilizing CBDa Can Prevent Infection From COVID-19.” The FDA says if a company makes a claim like this then the product is a drug and has to have the appropriate testing in order to make that claim. The FDA wrote, “These products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.”

Farm Animals

The FDA was also concerned in its warning letters that CBD products were being offered to farm animals that could produce a food products for humans. The FDA wrote,

To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. §§ 360b, 360ccc, and 360ccc-1. These products are not approved or index listed by the FDA, and therefore these products are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated under section 501(a)(5) of the FD&C Act 21 U.S.C. § 351(a)(5).

Cancer Claims

In addition to Covid claims, the FDA noted in its letter to Delta-8 Hemp that the company was making cancer claims. That letter highlighted a comment from the company’s website that said, “Delta-8 is known to be successful in many cancer treatments.” The FDA told the company, “Your Delta-8 THC products for humans are not generally recognized as safe and effective (GRASE) for their above-referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). ”

Mental Health

While many CBD companies suggest that the product helps anxiety, some of the companies in the latest batch of warning letters went even further. There were suggestions that it could help people suffering from schizophrenia and Alzheimer’s based on very small studies. The FDA is concerned that some patients would stop other medications and use these instead.

No Information

Of course, since the FDA hasn’t set any guidelines for CBD products, the companies aren’t able to introduce any information regarding dosage. The FDA complains the companies aren’t labeling the products correctly, but also won’t allow the companies to express these descriptions.

The FDA has requested written responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.


Dave HodesMarch 4, 2022
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13min190

When you see various agencies of the U.S. government getting involved in psychedelics, or changing their stance even a little (such as the DEA), that signals that the industry has hit its stride. 

Avenues of development open up, investor confidence increases, and researchers sense the ability to achieve goals that not only science but government supports. It begins to feel like everyone is on the same page. 

Here’s a look at what various government agencies are doing about psychedelics:

 

DEA. The Drug Enforcement Administration seems to want to help the psychedelics industry more than ever, but can’t help adding caveats about what that progress looks like. For example, the DEA reported in the Federal Registry on October 18, 2021 that there has been a significant increase in the use of schedule I hallucinogenic controlled substances for research and clinical trial purposes (MDMA and psilocybin chief among them), and that it has approved new applications for schedule I research registrations and new applications for registration from manufacturers and corresponding quota applications to grow, synthesize, extract, and manufacture dosage forms containing specific schedule I hallucinogenic substances for clinical trial purposes. The DEA also reported that it supports increased production quotas proposed for 2022 compared with production quotas for these substances in 2021. That’s good news for the industry—followed by more bad news. On January 14, 2022, the DEA proposed placing five tryptamine hallucinogens(4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiP) on schedule I of the Controlled Substances Act. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on anyone who handles (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or proposes to handle these five specific controlled substances. That could be a problem for Field Trip, a psychedelics therapy company. “Field Trip’s FT-104 is a prodrug of 4-OH-DiPT, so this will add some paperwork and delays to their efforts in the U.S.,” Matt Baggott, co-founder and CEO of Tactogen, a pharmatech company, wrote in a tweet about the DEA news.It’s worth noting that HHS provided DEA with an analysis of these compounds in 2012 and DEA failed to act until now. This raises the question of whether this scheduling is in response to the increased interest in psychedelic medicine.”

 

FDA. Probably the most active government psychedelics supporter is the Food and Drug Administration because of the critical role it plays in assessing any drug that wants to be FDA-approved and sold to the public. The agency has picked up the pace in its work with psychedelics. But it is still charged with an exceptional sense of prudence when working to legitimize novel compounds. In a commentary published in the American Journal of Medicine in January, Attorney Matt Lamkin, associate professor at the University of Tulsa College of Law, discussed the role of the FDA as research into psychedelics explodes. “Incorporating psychedelic drugs into clinical practice will require peeling back multiple layers of legal prohibition, clarifying prescribing guidelines, and developing treatment models that work for drug makers, physicians, and payers.” He went on to cite various achievements of the FDA and psychedelics: granting breakthrough therapy status to expedite the development and review of multiple psychedelic drugs; approval in 2019 of esketamine as a therapy for treatment-resistant depression; the promising results from an FDA-approved phase 2 trial of psilocybin as a treatment for major depressive disorder; and in June, when researchers published results from a phase 3 trial—the final phase before seeking FDA approval—studying 3,4-methyl-enedioxymethamphetamine (MDMA) as a treatment for posttraumatic stress disorder. Still, Lamkin was cautious about how and what the FDA could do. “Although the psychedelic research revival is yielding promising results, challenges remain before these drugs will find their way into clinical practice. Yet this plodding process could enhance the likelihood that these therapies will actually take root,” Lamkin wrote. “Given the longstanding skepticism toward psychedelic interventions, moving too swiftly might risk a backlash that could further stall research. Proceeding both with caution and openness offers the best hope for harnessing the potential benefits of these drugs while mitigating their risks.”

 

NAS. The National Academies of Science, Engineering and Medicine is focusing more attention on the psychedelics arena. For example, on March 29, the NAS will be conducting a workshop exploring psychedelics and entactogens as treatments for psychiatric disorders. The NAS noted on its website about the workshop that, with activity and interest in this field continuing to grow, the workshop “will provide a venue to explore strategies for harnessing the potential of these agents to combat mental illness.” Invited speakers will discuss the neurobiology of the therapeutic effects, strategies for optimizing the safety, efficacy, and patient stratification, and lessons learned that may help the identification of new classes of therapeutic agents. The workshop will explore the unique challenges and considerations presented by compounds that induce profound changes in consciousness, including those related to clinical trial design, medical ethics, and the psychosocial contexts of drug administration. The workshop is sponsored by the Department of Health and Human Services and the National Science Foundation.

 

NIH. The National Institutes of Health discussed psychedelics favorably at the National Institutes of Health’s FY22 Budget and the State of Medical Research hearing before the Subcommittee on Labor, Health and Human Services Education and Related Agencies on May 26, 2021. “I think as we’ve learned more about how the brain works we began to realize that these are potential tools for research purposes and might be clinically beneficial,” Francis Collins, director of the NIH said, referring to psychedelics such as psilocybin and MDMA. Collins said there has been a resurgence of interest in psychedelic drugs, which for a while “were sort of considered not an area that researchers legitimately ought to go after.” Additionally, on October 20, 2021, Johns Hopkins Medicine announced that the National Institute on Drug Abuse (NIDA) within the NIH, had awarded a grant of $4 million to fund a study using psilocybin as a therapeutic agent for smoking cessation. It is the first grant awarded by the United States government for research on psilocybin for tobacco use in 50 years. The multi-site, three-year study will be led by researchers with Johns Hopkins Medicine in collaboration with researchers at the University of Alabama at Birmingham.

 

NSF. The National Science Foundation is stepping up its support of psychedelics studies. One example is a study on how psilocybin and LSD work on brain activity, funded in part by an NSF grant for a six year study of various interdisciplinary training elements for complex networks and systems. 

 

USDA. The U.S. Department of Agriculture is on the lookout for ketamine. According to a Consumer Reports analysis of data from the Food Safety and Inspection Service, a branch of the U.S. Department of Agriculture, trace amounts of ketamine may have appeared in the U.S. meat supply more often than was previously known, pointing to new testing technologies that can better show what’s in meat today. The data for Consumer Report’s assertion came from the USDA’s Food Safety and Inspection Service (FSIS), the agency responsible for ensuring the safety of the U.S. meat supply. Emilio Esteban, chief scientist for the FSIS, said that the results should be discounted because they came from unconfirmed screening tests. “These results are credible enough that you would expect the government to take the warning signs seriously,” says James E. Rogers, Ph.D., who was a microbiologist at the FSIS for 13 years before becoming director of food safety research and testing at Consumer Reports. “You would hope the results would prompt the agency to look into why these drugs may be present, what risks they could pose, and what could be done to protect consumers.”


Debra BorchardtFebruary 3, 2022
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5min80

Psychedelic mental health company Novamind Inc. (OTCQB: NVMDF) announced it has been selected by the Ketamine Research Foundation (KRF) to host a phase II clinical trial investigating ketamine-assisted psychotherapy (KAP) for adults with life-threatening illness (the “Conscious Dying/Conscious Living Trial”).

Novamind said in a statement that the FDA approval of the study’s KAP protocol marks a first in the investigation of KAP for end-of-life patients and its potential to serve as a model of care for this difficult-to-treat population. Over the course of six weeks, study participants will undergo two KAP sessions at Novamind’s Murray, Utah research site under the supervision of clinical experts.

“This study is an important addition to the clinical care and research opportunities for patients within the Psychedelic Palliative Care program that we are building at Novamind,” said Dr. Paul Thielking, Chief Scientific Officer and Principal Investigator at Novamind’s Murray research site. “I’ve worked with this population for most of my career and, unfortunately, I’ve sometimes felt limited in what I can offer my patients to ease their emotional distress. The findings will contribute to the evidence for using KAP with patients who have a life-threatening illness and offer new insights into alternative treatments.”

According to the company, the mental health toll of a terminal illness is well-documented with between 24% to 70% of patients experiencing depression with significant negative impacts on quality of life.For patients with shortened life expectancy, ketamine may reduce symptoms of depression, anxiety and existential distress, and improve quality of life.

New Proposed Legislation

Two weeks ago Marijuana Moment reported that Bipartisan members of Congress sent a letter to the Drug Enforcement Administration (DEA) requesting that terminally ill patients be allowed to use psilocybin as an investigational treatment without the fear of federal prosecution.

“Rep. Earl Blumenauer (D-OR) started circulating a Dear Colleague letter to build support for the request last month. Now signed by a coalition of lawmakers on both sides of the aisle, the letter to DEA stresses that there are state and federal right-to-try (RTT) laws that should make it so certain patients can obtain the psychedelic given that it’s shown early potential in ongoing clinical trials.”

The Conscious Dying/Conscious Living Trial is sponsored by the KRF, a non-profit leader in ketamine research, advocacy and clinical training. Phil Wolfson, MD is the Founder and CEO of KRF and a pioneering practitioner and instructor of KAP. He is also a Principal Investigator for the Multidisciplinary Association for Psychedelic Studies (MAPS)-sponsored phase II study of MDMA-assisted psychotherapy for individuals with significant anxiety due to life-threatening illnesses.

Dr. Wolfson commented, “Ketamine is still considered a novel treatment option for psychiatric illness and can sometimes be seen as controversial. Now with FDA approval, we’re hopeful that this ground-breaking study will demonstrate KAP’s potential to relieve distress and serve as a model for practitioners of palliative care, hospice and mental health professionals engaged with those who are facing death, to assist in their attitudes and choices for their remaining time.”

StaffOctober 11, 2021
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4min40

In a big “oops we goofed,”  the Food and Drug Administration (FDA)  took back its September 14 Marketing Denial Order for some of Turning Point Brands, Inc.  (NYSE: TPB) vape products. Turning Point said all of its proprietary vape products, including its Solace branded e-liquids, will continue to be marketed while they remain under review. They are currently under a pending Premarket Tobacco Product Applications (“PMTAs”) review.

Turning Point said that in its rescission letter the FDA stated, “Upon further review of the administrative record, FDA found relevant information that was not adequately assessed. Specifically, your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.” The letter further clarified that “at present, in light of the unusual circumstances, FDA has no intention of initiating an enforcement action against” the products.

“We are encouraged by the FDA’s decision to reconsider our product applications and look forward to engaging the agency as our PMTAs are reviewed,” said Larry Wexler, President and CEO, Turning Point Brands. “It is important that the PMTA process is transparent, purposeful, and evidence-based. Our organization dedicated significant time and resources in filing our applications in accordance with agency guidance. We remain hopeful that the depth and range of our studies and data will persuade the FDA that the continued marketing of our vapor products is appropriate for the protection of the public health and that the agency will ultimately preserve a diverse vapor market for the more than 30 million American adult smokers who may wish to transition from combustible cigarettes to lower risk alternatives.”

Turning Point had been selling vape products under the label Solace with flavors like Peach, Mango, and Marshmallow Crispy. These sugary flavors have been very popular with underage consumers and were a big selling point for the competitor Juul. Solace noted on its website that Federal law required e-liquid companies to submit a Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA) in order to continue selling products in the United States. These applications require that e-liquid companies demonstrate that products are “appropriate for the protection of public health.”

Turning Point has reported spending $14 million in 2020 on the PMTA application according to the company’s annual filing. In 2019, the company spent  $2.2 million on the PMTA. Turning Point also said that as a result of the rescission letter, it withdrew both the petition for relief and motion to stay that it had filed with the 6th Circuit Court of Appeals.


StaffAugust 13, 2021
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8min151

Charlotte’s Web (OTC: CWBHF) CEO Deanie Elsner addressed the company’s recent rejection letter by the FDA in the company’s earnings call on Thursday. Since the passage of the 2018 Farm Bill that legalized hemp, the issue of CBD products has remained in a grey area. The FDA has had several public meetings and accepted public comments on the subject, but it still hasn’t made any specific decisions.

Charlotte’s Web was specifically focused on a regulatory pathway for full spectrum hemp extract with naturally occurring CBD. CBD products remain unregulated as the industry has grown to become a $3 billion to $4 billion industry.

FDA Punts To Congress

“After 2.5 years, it has become increasingly more apparent that in the FDA’s own words, potential legislation might be appropriate to enable a framework for under which the FDA can regulate full spectrum hemp extracts as dietary supplements,” said Elsner. “During the second quarter of 2021, we put this thesis to test by formally submitting a new dietary ingredient notification to the FDA for our full spectrum hemp extract as they have been recommending. The FDA responded with an objection letter to our NDI notification. Their response substantially based on their drug preclusion provision reveals that legislation is required to enable the FDA to establish a regulatory oversight for full spectrum hemp extracts as dietary supplements. Both the House and the Senate have introduced bills that would recognize hemp CBD as a dietary supplement and we are encouraged by this progress.”

When asked about the specifics of the letter, Elsner went on to say, “I will start with we were disappointed and strongly disagreed with not just the conclusion that they advanced, but the reasoning for their conclusions, because their letter back to us contained a significant amount of factual inaccuracies. And so the first thing I would tell you to do is on our website in the IR section, we have posted our response to the FDA. And we laid out an excruciating detail why we think they need to create the record in terms of what we submitted and what they concluded.

Now, that said, they drew a conclusion based on two examples. One was, they can’t move forward with an NDI as a dietary supplement because CBD is precluded, because it’s already a drug. And as you know, six months prior to the hemp bill being signed into law in December 2018, a drug was approved that’s CBD isolate. The second reason why they objected to our NDI was that they expressed safety concerns. And I think that’s the part that we are looking for a correction on, because regarding safety, the conclusions drawn just don’t appear to be based on the data we provided in our NDI. So, that’s we are trying to get focused on. In terms of what does it mean, I think what you are getting to is, it is the industry has been caught in a little bit of a catch-22, because the FDA has not been clear about the process by which they want companies to go through to gain regulatory clarity. And Congress has been pointing to the FDA to take responsibility for this.

And so our decision was full transparency, to force the issue to see who has the next decision. And with the FDA objecting to our NDI, it becomes very clear that the regulatory process to get established has to start with Congress, legislative and the FDA to regulate the dietary supplement for CBD, and then FDA can regulate within. And so I am confident there is a way to do this. Over the last 18 months, we have met with the FDA, about eight to ten different times and our meetings were very constructive. I have got a great deal of respect for the FDA. But I think they are in a bit of a catch-22, because they have approved the drug. And they can’t seem to move away from that precedent. And so Congress has to act. And I think once Congress acts, the FDA can be very clear about the process. The process is scientific. It’s intense. There is a ton of data that we have got to do to submit for it. And I feel really good having gone through this knowing what they are looking for. But now we need Congress to act. And when that happens, I think the category will be able to submit NDIs and the whole thing will begin to open up.”

THC Challenge

Elsner was asked whether relying on Congress would be any better and she answered, “This is not just a CBD hemp industry challenge. This is a THC sector challenge, because we are going through with hemp extracts with naturally occurring CBD is exactly what the cannabis industry is going to have to do following us. And so this is not Congress, maybe or maybe not engaging on the hemp CBD industry. This is Congress looking at a category today, that is roughly $17 billion to $20 billion in total in the US across 11 states where cannabis is legal and CBD participates. And so some kind of resolution has to be landed for how both of these categories are regulated. And the FDA has to have clarity and perspective about how they want companies to produce safe products for consumers in a way that is holding manufacturers to a very high level of standard. And so we are doing this for ourselves, but doing this for our category. We are doing this in support of our consumers. But it’s the whole sector that is going to put the pressure for Congress to act and push the FDA to move forward. And we will continue to push both fronts.”


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The Green Market Report focuses on the financial news of the rapidly growing cannabis industry. Our target approach filters out the daily noise and does a deep dive into the financial, business and economic side of the cannabis industry. Our team is cultivating the industry’s critical news into one source and providing open source insights and data analysis


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