There are 20,000 drugs in active development globally. More novel drugs made their market debut in 2020 than in any other year, with 82 released onto the market in total, which is way ahead of the previous record of 68 in 2018.
The world pharmaceutical market was worth an estimated $1.2 trillion in 2020 and is one of the most profitable industries in the world.
And as well as Big Pharma is doing today, even with its share of failures, it is ready and waiting for the next big thing: a psychedelic drug that does what no other pharmaceutical can do for treating a growing range of mental health conditions, potentially representing billions in profits.
Big Pharma company leaders know that people suffering from depression or PTSD, for example, are tired of the whole pharmaceutical runaround—taking a certain prescribed drug for depression, then taking another drug to counter the side effects of that depression drug—in an endless cycle of drug-taking for the rest of their lives.
These patients are getting relief, yes, but only because the usually recommended pharmaceuticals are numbing their brains or masking the signs of their afflictions, essentially addicting them to a chemical regimen that could cause more mental or physical damage in the long run.
But today, better tuned-in science appears to be supporting psychedelics for the treatment of these afflictions. Participants in one clinical trial with psilocybin reported only mild-to-moderate headaches, with researchers concluding that this intervention may be more acceptable to patients than widely prescribed antidepressant medications that “confer substantially more problematic effects (such as suicidal ideation, decrease in sexual drive, and weight gain). The effectiveness of psilocybin therapy after a single or only a few administrations represents another substantial advantage over commonly used antidepressants that require daily administration.”
Big Pharma is closely monitoring, and in some cases, carefully partnering with psychedelics companies to do more research and development into psychedelics to find better ways of administering them—such as creating psychedelics that have a non-hallucinogenic experience, or using other stronger psychedelics such as N, N-dimethyltryptamine (DMT) in controlled settings that allow shorter durations of therapy and help save the patient time and money.
Big Pharma doesn’t like some of what it sees—they would like more rigor in clinical trials, and they know that there are significant constraints in developing a drug for the central nervous system that must cross the blood-brain barrier all humans have for limiting the entry of toxins, pathogens, and blood cells to the brain.
And psychedelics researchers urge caution in going too fast too soon. Fred Barrett, a cognitive neuroscientist with training in behavioral pharmacology who has been conducting psychedelic research at Johns Hopkins University since 2013, told Chemical and Engineering News that psychedelics aren’t miracle drugs. “I think there has to be a little bit of tempering of enthusiasm here. We really need to be careful not to begin to treat these things as a panacea,” he said.
Big Pharma is seeing the psychedelics industry slowly conform more to their model of pharmaceutical development: broadening the number of participants, making psychedelics research more understandable to them, and taking the mystery out of toying with powerful, naturally occurring substances that are being shown as better ways of overcoming difficult and sometimes complicated unmet medical needs.
As a result, Big Pharma collaborations and connections and partnerships with psychedelics companies have begun in earnest.
One example: Beckley Psytech Limited, a private company dedicated to addressing neurological and psychiatric disorders through the application of psychedelic medicines, and Lophora ApS, a drug discovery company working in the central nervous system arena, just announced they have entered into a research and development collaboration. Under the terms of the agreement, Beckley Psytech will jointly fund continuing development of the Lophora pipeline and collaborate broadly on research and development.
Another: In January, Mindset Pharma’s CEO James Lanthier told Forbes that their deal with Otsuka Pharmaceutical, a huge multinational drug development company headquartered in Tokyo working to find novel drugs for treating conditions of the central nervous system, where a division of the company gave MindSet $5 million to help with psychedelics research and development, is the first partnership between a category-leading pharmaceutical company and a psychedelic biotech company focused on new psychedelic drugs. “Our partnership with them is significant as the combination of funding and Otsuka’s operational expertise significantly increases the likelihood of success for our new drug programs,” Lanthier said.
And U.S. pharma monster company Merck, with $48.7 billion in sales in 2021, is working with Novamind (OTC: NVMDF), a mental health company using psychedelic medicine through a network of clinics and clinical research sites, on a clinical trial focused on treatment-resistant depression. The main purpose of this study is to assess the efficacy and safety of daily and intermittent dosing of Merck’s MK-1942 drug formulation compared to placebo among participants with treatment-resistant depression (TRD) on a stable course of antidepressant therapy. The trial will be done at Novamind’s subsidiary, Cedar Clinical Research, the same clinic where Janssen Pharmaceutical Company developed Spravato in March 2019, a nasal spray for treating depression that is widely considered the first psychedelic medicine to be approved by the FDA.
“The stigma has certainly worn off,” Yaron Conforti, the CEO, and director of Novamind said in a YouTube video on their website. “I think that there is a vision broadly for the sector and for our company that we like to see a future where people interact as a patient with mental health in psychiatry much as they do with their chiropractor or cardiologists for that matter. That is a fairly simplified statement I just made but when you factor in what is required to get to that point, there is a lot of heavy lifting,” Conforti said. “The new therapies coming online are also focused on very particular indications of patient groups, as MDMA focused on PTSD for example. I think that mobilizing an entire patient group and providing them with access to an alternative therapy that has proved to be very safe and efficacious is going to have an enlightening effect.”
For now, as Big Pharma eyes psychedelics and builds a rationale for inclusion with psychedelics, there is still much that needs to be worked out even on a very basic level.
For example, Big Pharma’s intrigue with psychedelics could be tempered by ongoing studies comparing the usual mainstream pharmaceuticals with psychedelics, such as the case with one study demonstrating that a common anti-depressant pharmaceutical currently on the market (escitalopram) fared no better than psilocybin in treating depression, except perhaps in the side effects category (which includes headache, nausea, diarrhea, dry mouth, increased sweating, feeling nervous, restless, fatigued, or having trouble sleeping). “But the analyses of these outcomes lacked correction for multiple comparisons,” researchers concluded. “Larger and longer trials are required to compare psilocybin with established antidepressants.”
Mark Wingertzahn, chief science officer at Wesana Health, told Pharmaceutical Executive magazine that companies like GSK and Pfizer once had very large development programs in [mental health]. “But these research efforts have largely been shelved due to the lack of novel drug candidates with a better safety and efficacy profile compared to today’s antidepressants,” he said. Wesana is developing a drug to deliver a novel depression treatment protocol that includes a single high dose of psilocybin followed by a maintenance regimen of a non-hallucinogenic dose of psilocybin combined with cannabidiol (CBD). “Once everyone believes psychedelics may be the future of mental health treatment, then it becomes like any other drug that is currently being evaluated under drug development principles in that area,” Wingertzahn said. “This will enable us to generate hard data to allow regulators and clinicians to ascertain patient populations that may experience the most benefit from this ‘new’ old class of agents.”