We’ve been writing about psychedelics on this blog now for three years. I believe the first article I wrote covered Food and Drug Administration (FDA) approval of Compass Pathway’s drug trial for COMP360, a psilocybin formulation that eventually was patented. Since that time, a LOT has happened in the space, and we have seen all sorts of people pile in (for better or worse). At this point, psychedelics are having a cultural renaissance.
Today I’d like to step back and look at what is happening in this space, big picture, because it’s a lot more complex and fragmented than people tend to understand. I think about psychedelics as three big areas: the pharma space, the technology space and the decriminalization space. And then “other”. I’ll give some thoughts on each below.
The Pharma Space
This is now a land rush. By my count, we have a grand total of 28 distinct drugs in the FDA approval pipeline, introduced or sponsored by a broad mix of nonprofit, private and public companies. The breakdown is as follows:
- one drug in an ongoing Phase 3 trial
- seven drugs in ongoing Phase 2 trials
- eight drugs in announced Phase 2 trials
- three drugs in Phase 1/2 (dose escalation) trials
- four drugs in ongoing Phase 1 trials
- five drugs in announced Phase 1 trials
That is a lot of drugs, and a lot of trials, and we will see more soon. These trials look at scheduled molecules including psilocybin, LSD, ayahuasca, DMT, ibogaine, ketamine and MDMA, as well as their variants and analogues. (People argue about whether MDMA and ketamine are “true psychedelics”, but I’m counting them.) The trials target treatment of everything from drug abuse to depression to eating disorders, and the subject populations include everyone from stroke victims to alcoholics and autistic adults.
In all, scientists, advocates, investors and even government are betting that psychedelic drugs hold tremendous potential for treating a panoply of ills. Which of these drugs end up making it across the finish line, and when, remains an open question. For now it seems certain we’ll see an MDMA drug in circulation in two years or less, with more to follow.
The Technology Space
People are working hard right now to optimize the production and manufacture of psychedelic drugs, inside and outside of drug design. This space is being innovated heavily. Five years from now, when people are growing psilocybin mushrooms at scale under licensure here in Oregon—and have been for a while—setups will be different than anything out there today.
Innovation will not be limited to the production side, however. Technologies and methods involving dose moderation, delivery systems (including nano-methods), digital therapeutics, biometric protocols, data tracking and any number of applications will have advanced. Much of this technology will be bought, sold, reconfigured and reapplied for other purposes and applications, as well.
The Decriminalization Space
People often confuse the concepts of drug decriminalization and legalization. With decriminalization, restrictive laws remain on the books but are generally not enforced. With legalization, those laws are removed altogether. In the context of controlled substances, like psilocybin or cannabis before it here in Oregon, criminal laws are replaced with a regulatory regime.
It has been over two years since the City of Denver first decriminalized psilocybin. Since then, other cities and states have followed suit, with Oregon going as far as decriminalizing all drugs entirely. In March, when we last surveyed the national landscape, a dozen cities and states had made significant progress on at least some aspect of drug decriminalization. That number has since ticked up.
Efforts are also underway through the courts to remove legal obstacles to psychedelic drug access, albeit in narrower circumstances. Today, doctors are suing DEA for permission to prescribe psychedelic drugs to terminal patients. Other plaintiffs have notched wins against state actors in the context of religious use exemptions. These lawsuits raise awareness, but they also have practical effect.
There are many opportunities for individuals and businesses in the psychedelics space that do not fit neatly into any of the categories listed above. Outside of our busy ketamine practice, we have worked and consulted with businesses and individuals in a variety of psychedelic pursuits. This has involved everything from public company acquisition of a mushroom substrate business, to clearance work for a Hollywood film studio wishing to document the use of MDMA. Broad segments of society are now interested in the use of psychedelic drugs. This means that opportunities for players in this space will continue to expand.