ketamine Archives - Green Market Report

Dave HodesApril 5, 2022
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8min13550

Most people in the psychedelics industry believe that the growing superstar of psychedelic medicines is psilocybin—the “psychedelic du jour” as one scientist put it to Psychedelia.

But ketamine is quickly changing that perception.

Ketamine was introduced to the market in 1970 as a U.S. Food and Drug Administration (FDA) approved anesthetic after clinical trials that began following its formulation in 1962. More than 20,000 research papers have been published on ketamine since 1965, mostly about its use as an anesthetic, according to a study

From the 1970s through the 1990s, ketamine usage increased both medically and recreationally.

In the late ‘90s and early 2000s, ketamine began to show evidence as an effective antidepressant. Since 2006, 225 random controlled trials, 51 meta-analyses, and more than 565 reviews have reported on ketamine’s effectiveness at alleviating refractory depression and anxiety, and more recently, suicidality and pain management.

Ketamine is also being investigated for use with eating disorders (though researchers say that more empirical research is needed).

The biggest advantage of ketamine is that it is generally believed to be an FDA-approved drug for psychedelic therapy. But an FDA alert issued in February stated that ketamine is not FDA-approved for the treatment of any psychiatric disorder, blurring the understanding of exactly how it should be used. 

However, the “S” form of ketamine, which is derived from ketamine and known as Johnson and Johnson’s Spravato (esketamine), is a Schedule III controlled substance that was approved by FDA in 2019 as a nasal spray for treatment-resistant depression in adults, and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior.

What’s more, questions about the efficacy of ketamine have arisen from research that suggests ketamine use can create psychiatric, cardiovascular, neurological, and other side effects. 

But those issues haven’t stopped its growing popularity as a treatment for depression and other neurological disorders. It makes ketamine a target for more research. And that is happening.

For example, in November 2021, Yale Department of Psychiatry researchers were awarded a $2 million grant from the Michael J. Fox Foundation for Parkinson’s Research to conduct a clinical trial of ketamine to treat depression in people with Parkinson’s disease. It is the first investigation of ketamine as an antidepressant in a neurological disorder.

Research and development activities for ketamine companies is on the rise as well.

PharmaTher (OTCQB: PHRRF) (CSE: PHRM), created to develop and commercialize specialty ketamine pharmaceuticals for mental health, is planning a Phase 3 clinical study to allow for FDA approval of Ketarx, their ketamine treatment for Parkinson’s disease.

Seelos Therapeutics (US:SEEL) is currently pursuing a two-part Phase 2 clinical trial for intranasal delivery of ketamine, with results expected in December 2022.

Atai Life Sciences N.V. (Nasdaq: ATAI), a clinical-stage biopharmaceutical company, announced in January that the FDA has given Investigational New Drug (IND) clearance to conduct a clinical study of ketamine. Atai plans to initiate the study early this year through its platform company, Perception Neuroscience.

Field Trip Health, (NASDAQ: FTRP) the largest provider of psychedelic-assisted therapies in Canada, continues to open ketamine clinics for therapeutic use across the U.S. and Canada, with the goal of opening up to 75 ketamine clinics by 2023 to join Field Trip clinics that are already operating in such locations as downtown New York and Los Angeles (both cities also have multiple private ketamine therapy businesses not associated with Field Trip). 

Field Trip began operations in March 2020. They recently applied to the Canadian government to legally use psilocybin and MDMA-assisted therapies under Canada’s Special Access Program.

The use of ketamine as a fast-acting antidepressant in treatment-resistant patients has boosted the interest in the mechanism of action both in psychiatry and in the wider area of neuroscience. “Ketamine can make a genuine leap forward in the therapy of depression,” a study concluded. “Its clear effectiveness in reducing symptoms of depression and suicidal ideation, either after a single administration, or especially when administered repeatedly in addition to another antidepressant, is an extremely promising factor in the treatment of depression. Furthermore, research on new molecules designed to reproduce the rapid and sustained antidepressant effects of ketamine, without its adverse effects, allows us to assume that a new era in the pharmacology of antidepressants has already begun.”


StaffMarch 7, 2022
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3min6670

 Seelos Therapeutics, Inc. (Nasdaq: SEEL) announced its year-end 2021 business and clinical update. In the second half of 2021, Seelos said it had achieved several major clinical and financial milestones and continued to make progress on its multiple clinical-stage development programs. As of year-end 2021, Seelos had $78.7mm of cash.

SLS-002 (intranasal racemic ketamine)

  • In July, Seelos began dosing patients in Part 2 of the registration-directed, double-blind, placebo-controlled cohort in Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).
  • In June, based on feedback from a Type C meeting with the FDA, Seelos is planning to expand the size of the trial and number of sites now that this trial has been labeled registration directed.
  • In October, Seelos presented a poster titled “A Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with Major Depressive Disorder at Imminent Risk of Suicide”, at the 2021 IASR/AFSP International Summit on Suicide Research Virtual Conference. SLS-002 demonstrated rapid, robust and sustained reductions on the Montgomery-Åsberg Depression Rating Scale (MADRS), the Clinical Global Impression of Severity for Suicidal Ideation and Behavior, the Patient Global Impression of severity for Suicidal Ideation and Behavior, and the Sheehan-Suicidality Tracking Scale. Additionally, the group mean met the MADRS remission criteria initially on day 6 after only 2 doses of SLS-002.

“In the second half of 2021, we continued to accomplish several significant milestones and continued to execute in the face of one of the most difficult environments for publicly-traded biotech companies that I’ve seen in my career,” said Raj Mehra Ph.D., Chairman and CEO of Seelos. “We began the placebo-controlled Part 2 of the registration directed study of SLS-002 and plan to enroll in over 30 sites. The SLS-005 IV trehalose program’s registrational study in ALS, which was accepted into the HEALEY ALS Platform Trial at Harvard, commenced dosing participants in February 2022 and our IND was accepted to study SLS-005 in spinocerebellar ataxia and its Phase IIb/III pivotal study should begin dosing in Q2 2022. We have begun additional in vivo studies with our Parkinson’s disease-focused gene therapy program SLS-004 after demonstrating its capability of reducing alpha-synuclein expression. We look forward to continuing to provide meaningful updates on the current state of progress on all of our programs as well as additional initiatives.”


Debra BorchardtFebruary 15, 2022
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4min7740

Ehave, Inc. (OTC Pink: EHVVF) reported that its wholly-owned subsidiary, KetaDASH has started clinical operations that are offering in-home ketamine therapy to patients suffering from treatment-resistant mental health issues. Ehave said that the treatment will be offered in the San Francisco Bay Area and Greater Sacramento Area first with plans to expand to other markets in the coming months.

“I have over-seen over 600 successful ketamine treatments and have been amazed by the positive results,” said Jeffrey D. Kamlet, MD, Chief Medical Officer of Ehave. “We are pleased to begin our U.S. rollout in Sacramento and San Francisco, with plans to scale our business in other cities over the coming months. Even though ketamine is a relatively safe drug to administer, we have made patient safety our top priority. As such, KetaDASH treatments begin with a telehealth med screen and then treatments will be conducted by a team of experienced nurses who will come to your home, office, or mobile location and administer your session. Post ketamine therapy will be available and is recommended. We believe this will give our clients the confidence in knowing they are receiving the utmost support throughout their treatment experience. This pioneering approach is a departure from ketamine telehealth models, which mail prescriptions and do not provide in-person support or guidance during the psychedelic experience.”

The service isn’t cheap. A two-hour ketamine treatment with psychotherapy costs $899. A one-hour ketamine treatment is $599 and that comes with an experienced nurse.  KetaDASH treatments will be conducted by a team of experienced nurses that can go to a patient’s home, office, or mobile location after initial telemedicine screening and provide a complete ketamine experience, with a focus on set and setting, with packages that include telemedicine integration with psychotherapists.

This approach is different from other companies that mostly offer in-clinic intravenous, treatment, or unsupervised telehealth models to an at-home ketamine administration with telehealth and in-person medical supervision. A typical KetaDASH experience incorporates a prescribing doctor, a nurse for administration and monitoring, and psychotherapists for integration, all from the patient’s home. KetaDASH also offers other IV therapies for hydration and wellness.

Ben Kaplan, CEO of Ehave, said, “For patients with mental health disorders, the need for more effective treatment options is greater now than it ever has been in the past. When used at sub-anesthetic doses, ketamine has proven effective in treating many psychiatric disorders. KetaDASH will provide better access to this treatment for a larger patient population in a safe and convenient way. Through our KetaDASH mobile clinics, patients will benefit from receiving the ketamine therapy in the privacy and comfort of their own homes. Patient safety is our top priority, so all ketamine treatments will be delivered by certified medical professionals. The KetaDASH platform will utilize proprietary software developed by Ehave which will allow patients and their associated nurses to view detailed reports on the ketamine therapy’s progress.”

 


StaffNovember 24, 2021
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4min7680

Seelos Therapeutics, Inc. (Nasdaq: SEEL) is buying the worldwide license (excluding China, Taiwan, Macau and Hong Kong) from iX Biopharma Ltd (iX Biopharma) for Wafermine, a sublingual racemic ketamine wafer, and a worldwide license for other sublingual ketamine wafers, delivered using a proprietary fast-dissolving wafer-based drug delivery platform technology known as WaferiX. Seelos said it is paying roughly $9 million in cash and stocks. Seelos said it plans to evaluate the sublingual ketamine, now named SLS-003, in pain indications such as chronic neuropathic pain and Complex Regional Pain Syndrome (CRPS) and in additional psychiatric disorders, including post-traumatic stress disorder (PTSD).

The company also said in a statement that the Food and Drug Administration (FDA) has granted Wafermine Orphan Drug designation for the treatment of CRPS.

“Our licensing of this new program broadens Seelos’ ketamine franchise with a formulation that we believe will be more suitable for chronic dosing in indications like CRPS and PTSD, which are both very difficult indications to treat effectively,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “The pharmacokinetic, pharmacodynamic and safety profiles of SLS-003 that have been demonstrated to date suggest a formulation with the potential of being prescribed with less restrictions than current formulations. Our team is very excited to be developing both acute, in SLS-002, and a potentially chronic, in SLS-003, ketamine-based therapy programs. We look forward to initiating studies with SLS-003 in 2022 and our recent capital raises have accounted for the expected development costs for initiating studies.”

Eddy Lee, Chairman and CEO of iX Biopharma added, “We are delighted to collaborate with Seelos Therapeutics, whose deep insights in ketamine drug development make them an ideal partner to further the development of Wafermine and the other sublingual ketamine products,” said . “Licensing our WaferiX-based pharmaceutical drugs to suitable third parties for development and commercialization is a core strategy to unlock the value of our assets. We are therefore excited that this commercially significant agreement with Seelos is a validation of our ability to deliver on this strategy.”

$20 Million Note

In addition to the acquisition, Seelos announced the placement of a $22 million senior secured convertible note and shares of Seelos common stock to Lind Global Asset Management V, LLC, managed by The Lind Partners, a New York institutional fund manager and an existing investor in Seelos. Seelos will receive $20.0 million in gross proceeds. Seelos said it plans to use the proceeds for general corporate purposes and to advance the development of its product candidates.

“2021 has been a volatile year for the biotech sector and this financial commitment from the team at Lind further strengthens our balance sheet and provides for additional future funding,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “The team at Lind has been a terrific partner for us and their creative and innovative funding solutions are thoughtfully and strategically designed to fit the needs of their partners. We are proud to once again work together, and we look forward to the continued execution of our ongoing and future studies.”


Tee CorleyJuly 21, 2020
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6min24541

The psychedelic industry is seeing a boom in the creation and expansion of ketamine clinics. The growth is in this industry has come about as the acceptance of the medical marijuana industry spread across North America. A group of medical professionals believes that this stigmatized substance may offer effective treatment for those suffering from mental health crises.

Known colloquially as special K, super acid, and cat valium, ketamine was added to the U.S. schedule of controlled substances in 1999. A “dissociative anesthetic,” ketamine has a street reputation for its dream-like high.

The illegal use of ketamine for recreation shrouds this medication in the familiar stigma that befell medical marijuana.

As the world changes and cases of mental health disorders rise, however, progressive medical researchers like Dr. Robert McIntyre of the Canadian Rapid Treatment Centre of Excellence (CRTCE) sees potential in ketamine for people who haven’t found relief with SSRIs, benzodiazepines or other prescription antidepressants and antianxiety medications.

What does the research say?

Dr. McIntyre recently released two new research studies in which patients suffering from suicidality, major depressive disorder (MDD), generalized anxiety disorder (GAD) and bipolar disorder (BD) were introduced to a new treatment: IV ketamine.

According to the researchers, these community trials were performed on patients who have previously tried prescription antidepressants in the past with little to no effect.

In February 2020, Dr. McIntyre and his team performed a review of the current data surrounding ketamine. The sheer number of trials the researchers analyzed, totalling 119 relevant and completed random clinical trials, suggests that Dr. McIntyre isn’t alone in recognizing the potential for IV ketamine.

Furthermore, these trials showed that IV ketamine given in a single dose of 0.5mg/kg over the course of 40 minutes had positive results lasting for a week. A few studies delivered 2 doses per week over the course of two weeks with positive results.

In his team’s study, published in May 2020, Dr. McIntyre and his team tested a single dose of IV ketamine on patients with treatment-resistant mood disorders. Specifically, this study measured the effects of IV ketamine on people with anxiety, irritability and agitation (AIA) and treatment-resistant major depressive disorder (MDD) and bipolar disorder (BD).

While the research is preliminary, with most studies, like this one, in phase II, the results are promising. Dr. McIntyre told us that these studies suggest “IV ketamine is effective in rapidly treating AIA and suicidal ideation in adults with treatment-resistant mood disorders.”

Why IV ketamine?

Yes, there are other ways for patients to get treatment with ketamine. Contacting your local dealer is not one of them.

Ketamine can be made into powders and pills, but these methods of administration are simply not as effective as taking ketamine intravenously and under the care of a medical professional. Dr. McIntyre explained that oral routes of administration are only about 10-20% bioavailable.

In March 2019, the FDA approved an intranasal form of ketamine called esketamine. This method is 50-60% absorbed by your body.

IV ketamine can be administered in under an hour and is 100% bioavailable. This means patients can get in and out and feeling better much more quickly and efficiently.

How soon will IV ketamine disrupt the pharmaceutical market?

Unfortunately, that’s a tough call to make. However, Dr. McIntyre points out that in the past decade, phase I, II and III trials have greatly increased. Phase III trials can make or break a product.

Still, Dr. McIntyre’s review of existing analyses shows what kinks still need to be resolved. For example, we have yet to control for size, weight and gender. Additionally, long term studies need to be conducted to determine the efficacy of repeated doses and how well ketamine is tolerated over time.

Our advice? Keep an eye on this market. The potential for a better way to treat complex mood disorders via IV ketamine seems apparent—an implication too important to ignore.


Debra BorchardtMay 12, 2020
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4min31100

Psychedelic medicine company Champignon Brands Inc.   (OTCQB: SHRMF) is acquiring California based ketamine treatment company Wellness Clinic of Orange County Inc. It is a cash and stock deal with Champignon paying  $600,000, plus 1 million common shares of Champignon and 500,000 common shares of Champignon payable only if the Wellness Clinic collects top-line revenue of at least $1,500,000, over the 18-month period.

“We are thrilled to begin executing on our North American expansion strategy by acquiring our first U.S. based, revenue-generating ketamine center- Wellness Clinic of Orange County,” said Dr. Roger McIntyre, Chief Executive Officer, Champignon. “This acquisition represents a major milestone as we begin to accelerate our vision of establishing significant scale and a sizable footprint of integrated ketamine centric clinics committed to providing innovative care and therapeutic options to improve the quality of life of patients suffering from chronic disease states that have failed conventional treatments.”

McIntyre was just appointed the company’s new CEO on May 11. He is a Professor of Psychiatry and Pharmacology at the University of Toronto and Head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, Canada. Dr. McIntyre is also Executive Director of the Brain and Cognition Discovery Foundation in Toronto; Director and Chair of the Scientific Advisory Board of the Depression and Bipolar Support Alliance (DBSA) in Chicago, Illinois.; Professor and Nanshan scholar at Guangzhou Medical University; and Adjunct Professor at the College of Medicine at Korea University.

The Wellness Clinic owns and operates a state-of-the-art ketamine infusion treatment center located within the Mission Hospital’s Laguna Beach campus. This clinic is actively involved in research and complementary treatment protocols. Supported by a breadth of peer-reviewed studies, as well as clinical trials, intravenous ketamine has emerged as a promising treatment option for many chronic diseases, such as depression, anxiety, post-traumatic stress disorder, fibromyalgia, and certain other pain disorders.

Dr. Michael Bronson of Wellness Clinic of Orange County said, “This is an exceptional opportunity to both collaborate and scale with Dr. McIntyre and the world-class team at Champignon; with the objective of remaining at the forefront of innovation in this burgeoning field.  We are excited for our patients, both current and future, as we work to provide them with the therapeutic options that they deserve.”

Terms

According to the company statement, the Initial Share Issuance shall be paid upon closing of the Acquisition, subject to a 12-month escrow, with 500,000 common shares released 6 months following the closing of the Acquisition and the remaining 500,000 shares released 12-months following the closing of the Acquisition. Each of the Initial Share Issuance and the Second Share Issuance are to be issued at a price per share determined using the average trading price of the common shares in accordance with the Canadian Securities Exchange (CSE) policies and applicable securities law. 

 


Debra BorchardtApril 10, 2020
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5min29320

Mushroom company Champignon Brands Inc. (OTC:SHRMF) has entered into a definitive agreement to acquire Canadian ketamine clinic operator AltMed Capital Corp. Champignon said that AltMed has a suite of assets that will hasten Champignon’s anticipated rollout of new clinics to be opened across the United States and Canada. Five new clinics in key markets, including New York, Florida and California, are anticipated to be fully operational by Q4 2020.

Deal Terms

Champignon will buy all the shares of AltMed for a total consideration of 55,124,000 common shares, common shares that are currently selling at roughly $0.59 placing a value on the deal of approximately $32 million. 16,522,000 shares will be subject only to applicable hold periods under securities legislation and 38,602,000 will be subject to voluntary resale restrictions and released in five equal tranches every three months with the first release commencing thirty days following closing.

AltMed Clinics

AltMed owns 75% of the CRTCE, a fully operational ketamine clinic located in Mississauga, Ontario, with over 18 months of operating history. The CRTCE was licensed in 2018 by the College of Physicians and Surgeons Ontario under OHPP (Out of Hospital Premise Program) to administer ketamine treatments for indications including but not limited to depression, bipolar disorder, post-traumatic stress disorder (PTSD) and obsessive-compulsive disorder (OCD).

The clinic has been licensed by Health Canada to dose eligible patients with psilocybin and is the only clinic in Canada to perform psilocybin doses under Health Canada approval. AltMed’s chief executive officer, Dr. Roger McIntyre, is a professor of psychiatry and pharmacology at the University of Toronto and head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, Canada.

“Founded and operated by Dr. McIntyre, the CRTCE has the human capital and unmatched R&D capabilities, with respect to rapid onset treatments such as ketamine, to revolutionize the treatment of depression, PTSD and substance use disorders,” said Gareth Birdsall, CEO of Champignon. “Champignon and AltMed will leverage Dr. McIntyre’s expertise, alongside the CRTCE’s existing SOPs, data-driven research sets and practitioner education modules, to roll out five unique ketamine clinics across Florida, California and the U.S. Eastern Seaboard. Our additional ketamine clinics are projected to be fully operational by Q4 2020. Furthermore, having previously completed funding rounds, our acquisition of AltMed will further bolster our corporate treasury.”

Study Trials

With this acquisition, Champignon will now have three trials in the Phase I stage and three trials in the preclinical stage during 2020. The company will also have seven IP patents for its ketamine/psilocybin delivery platforms and formulations.

In the second half of 2020, AltMed said it will start both comprehensive R&D campaigns as well as clinical trials, to be led and administered by leading M.D.s, clinicians, and researchers targeting the following indications:

  • Treatment-Resistant Depression (Dr. Roger McIntyre)
  • Addiction (Dr. Peggi Shepherd DeGroote)
  • PTSD/Traumatic Brain Injury (Dr. David Greenberg and Dr. Michel Rathbone)
  • Aging/Dementia (Dr. DW Molloy)
  • Anxiety/Obsessive-Compulsive Disorder (Dr. Michael Van Amerigan)

Pat McCutcheon, director of AltMed, said in a statement: “Together with Champignon’s existing novel ketamine delivery platforms, associated patents/IP and now advanced clinical infrastructure, we will look to deliver approved, point-of-care psychedelic treatments in clinics throughout Canada and the United States. Ketamine, psilocybin and MDMA have all been fast-tracked by the FDA and Health Canada with respect to R&D in DPS, and we will look to monetize our capabilities and human capital within this domain. Led by our accomplished operational team, comprised of experienced clinicians, academics and thought leaders within dynamic, blue-sky industries, we will be the global leader with regard to the application of rapid onset treatments and will continue to be a first-in-class, vertically integrated center that champions R&D, clinical research, knowledge translation, vocational rehabilitation, and psychotherapeutics, offering patient populations a wholesome and comprehensive treatment ecosystem.”


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