FDA Issues Draft Guidance For Clinical Studies On Psychedelics

The United States Food and Drug Administration, aka the FDA, issued the first-ever guidance for clinical studies on psychedelics, according to a news release issued Friday. They filed the 14-page document shortly after Congress introduced bipartisan legislation led by Texas Republican Representative Dan Crenshaw, directing the issuance of clinical trial guidelines.

They aimed the guidance specifically towards classical psychedelics, which include psilocybin, LSD, mescaline, and DMT, the psychoactive ingredient in ayahuasca, in addition to entactogens or empathogens such as MDMA. This means that it does not cover other drugs used therapeutically embraced by the psychedelic community, such as ketamine, which is technically a dissociative anesthetic that has hallucinogenic effects.

While the FDA guidance is new, research on the benefits of psychedelics is not. Applied Clinical Trials reports that there are currently 163 Phase I, II, or III studies on clinicaltrials.gov involving psychedelics. For instance, in January, MAPS Public Benefit Corporation, a biopharmaceutical company dedicated to psychedelic treatment, announced its Phase 3 clinical trial on MDMA-assisted therapy for post-traumatic stress disorder (PTSD) produced promising results.

“The Phase 3 confirmatory results support the development of MDMA-assisted therapy as a potentially new breakthrough therapy to treat individuals with PTSD—a patient population that is often left to suffer for years,” said Amy Emerson, chief executive officer of MAPS Public Benefit Corporation. MAPS plans to submit the new drug application to the FDA in the third quarter of 2023.

Like MAPS’ study on MDMA, psychedelic research to date has primarily been backed by private sponsors. Many of these may want nothing to do with the Feds and their infamously regressive views on psychedelics. The FDA approval process is expensive and riddled with red tape. Many companies may prefer to follow state guidelines and leave psychedelics, such as psilocybin, which researchers currently study for OCD, and alcohol use disorder, nestled in the safety of libertarian-esque gray areas. (Oregon and Colorado are the only states to decriminalize the supervised use of psychedelics). 

For example, let’s look at ketamine, which, as noted, is not technically a psychedelic. While Esketamine, or S-ketamine, the S enantiomer of ketamine, is FDA-approved as a nasal spray, many ketamine clinics and psychiatrists prefer to prescribe patients actual ketamine, off-label, because it’s not only more affordable but may work better than the version the FDA approved, which was only changed to S-ketamine in the first place so Johnson & Johnson could patent it under the brand name Spravato. 

However, if a substance earns FDA approval, it is easier to market and sell and could reach more consumers who trust that it’s met the FDA decision that the benefits outweigh the risk. For instance, Tryp Therapeutics is currently seeking FDA approval for psilocybin-assisted therapy to help those with irritable bowel syndrome (IBS).

While such studies show that psychedelics hold great therapeutic potential, as anyone with personal experience using psilocybin, MDMA, or other psychedelics can attest, the FDA asserts that they must address the challenges associated with designing clinical studies to evaluate the safety and effectiveness of psychedelics.

“Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies,” said Tiffany Farchione, M.D., director of the Division of Psychiatry at CDER.1, Applied Clinical Trials reports. 

The guidance addresses the psychoactive and hallucinogenic effects of psychedelics, the potential for abuse, and the importance of conscientious safety measures. It includes considerations for the importance of characterizing dose-response and the durability of any treatments. The draft also tackles potential drug interactions for patients on antidepressants or mood stabilizers such as lithium. 

Additionally, for any Schedule I controlled psychedelics, the FDA states that the research must comply with applicable Drug Enforcement Administration (DEA) regulatory requirements. 

It also tackles the role of psychotherapy within a psychedelic treatment, what folks in the community often describe as integration, or the therapeutic process of a patient going through therapy with a professional to integrate their experience into everyday life, ensuring that it’s not just a one-time trip, but an ongoing treatment plan. 

If anyone has thoughts on the draft guidance, the FDA accepts public comments for 60 days.