Mushrooms For Depression: FDA Approves Psilocybin for Clinical Trials.

It may have taken decades, but we’ve finally arrived at a place where marijuana is medically prescribed in about 29 states and Washington, D.C., and used often and everywhere. Cannabis—at the gym, in your morning smoothie and your lip balm—is becoming more mainstream by the day. So naturally, many wonder: What’s next? According to researchers at Johns Hopkins, it’s psilocybin, also known as the hallucinogen found in “magic mushrooms.”

And with good reason: The team there has been studying the effects of psilocybin for years, and this week they released a paper recommending the Food and Drug Administration reclassify the drug from Schedule I (where substances with no accepted medical use, and a high chance of abuse, rank) to Schedule IV (which contains drugs with a low risk of abuse and dependence, and are generally available with a prescription). Why? Their research suggests that psilocybin could be useful in treating, among other things, anxiety and depression—two illnesses that affect millions of people in today’s fast-paced, tech-driven world.

“We studied 51 cancer patients with substantial depression and/or anxiety attributed to their cancer—people with existential distress who can’t live their lives,” says the researcher Matthew Johnson, PhD, an associate professor of psychiatry and behavioral sciences at Johns Hopkins. “We found drastic reductions [in levels of anxiety and depression] after one high dose session, and the reductions remained six months later,” he says. Yes, there were fewer symptoms after a single dose of synthetic psilocybin—no typical cocktail of pills necessary (in fact, participants in the study were not permitted to take prescription antidepressants or antianxiety medications). Psilocybin is the naturally occurring, psychedelic ingredient found in around 200 species of mushrooms. Like cannabis, it is believed that psilocybin use by humans predates recorded history by at least a few thousand years. Also like cannabis, psilocybin has always been thought to have medical applications; and it has demonstrated promising, preliminary results in formal studies. In Silicon Valley and elsewhere, microdosing of psilocybin and LSD has become a trend, for medical and other purposes.

So who is leading the charge on psilocybin? Compass Pathways (“Compass”) is a life sciences and mental health company backed substantially by Peter Thiel, of PayPal and Privateer Holdings fame. The latter company is probably the largest private equity firm in the cannabis space, and has been for a while. Compass is a different type of outfit than Privateer, in that its purpose is to develop, own and market solutions (including a psilocybin drug), rather than take debt or equity positions in existing brands.

The biggest question of all, though, is what happens next with Compass and FDA. From a products-to-market perspective, Compass is in the second of three “trial” phases. The initially approved trial in this case is a “Phase 2b dose-ranging study” which has the purpose of testing for both efficacy and side effects. Typically, Phase 2 trials last several months to two years. About 33% of Phase 2 trials succeed; the rest fall through due to study failure or lack of funding.

If the Phase 2 trial succeeds, Compass and the FDA would need to agree on how a larger-scale, Phase 3 trial should be done, with 300 to 3,000 volunteers. That leg would last up to four years. Ultimately, if the Phase 3 trial shows that psilocybin is more effective and/or safer than current standard treatments, Compass would submit a “new drug application” to FDA for approval and post-market monitoring.

If everything goes well, we will probably see a psilocybin drug hit the market sometime in the next five to ten years. That’s a big “if”: Once trials start, it’s possible that the findings won’t pan out (although we are optimistic). The fact that FDA recently approved the first non-synthetic cannabis drug, Epidiolex, should give Compass some optimism that its psilocybin efforts have a real shot, and that the decision here will be entirely science-based and free of political considerations.

At some point soon, due to the Epidiolex approval, Congress or the DEA is going to have to re-schedule cannabidiol under the CSA. Perhaps one day they will have to do the same for psilocybin. Before that, who knows: It’s even possible that psilocybin, like cannabis, will be legalized in certain states.

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