/>iWe at Budding Trends have been optimistic, and then cautiously optimistic, that the legalization of psychedelics was close. This month, however, the U.S. Food and Drug Administration dealt a blow to our predictions. FDA decided not to approve Lykos Therapeutics, Inc.’s MDMA-assisted PTSD therapy at this time. Instead, FDA asked Lykos to further study the efficacy of the treatment. More specifically, FDA asked Lykos to conduct another Phase 3 trial to determine the drug’s efficacy and safety. Lykos intends to request reconsideration from FDA.
Some see this as a “huge blow to the field,” considering it a bellwether for other psychedelic drugs. Lykos’ CEO has called the decision “deeply disappointing” and stated that many of the requests from the agency “can be addressed with existing data, post-approval requirements or through reference to the scientific literature.” It is also, of course, disappointing to those individuals suffering from PTSD who may benefit from these treatments.
FDA’s Psychopharmacologic Drugs Advisory Committee vote earlier this summer made things difficult for the FDA, which historically sides with its advisors. Ultimately, it appears the FDA determined “there are significant limitations to the data contained in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication.” But, the FDA also stated to NPR that it would “continue to encourage research and drug development that will further innovation for psychedelic treatments and other therapies.”
Others in the industry have more of a Lloyd Christmas outlook. This is not an outright denial of MDMA therapies, and it certainly is not a referendum on the psychedelics industry as a whole.
According to NPR, Dr. Mason Marks, law professor and senior fellow with Project on Psychedelics Law and Regulation at Harvard Law School’s Petrie-Flom Center, didn’t see this as “any sign that progress is going to be slowed;” instead, he stated that “it might intensify because the other companies might see an opportunity to really get in there and compete.” Marks was concerned that the limitations of the trial could have required the FDA to impose so many restrictions that it would have been “impractical” for the treatment to reach its intended audience.
Doug Drysdale, CEO of Cybin – a psilocybin-based drug development company – stated that he thought the decision would just be a “delay,” believing that the program was “fixable” and would “likely lead to an approval at some point.” He went on to state that while the decision was “disappointing for patients,” there was “no real readthrough . . . to other psychedelic programs. What Lykos is doing is quite different and unique to them, and ultimately, the [Complete Response Letter] came because the NDA submission was just incomplete.”
The CEO Of LSD-focused MindMed, Rob Barrow, was likewise optimistic, positing that the FDA’s decision “reinforces the need for rigor and the highest quality studies and ethics and safety in these studies to ensure that, if we’re successful in illustrating p-value and clinical response, that we can make sure that transitions into a strong case for approval.”
Do we still think psychedelics likely are on the path to legalization in some form? Lykos’s bid to use psychedelics to treat PTSD was the furthest along to obtain FDA approval, but there are still other options. So, yes, we’re telling you there’s a chance.
