Company Hopes It Can Convince FDA to Reevaluate Drug as Treatment for PTSD in Future
The US Food and Drug Administration recently rejected a company’s proposed treatment for PTSD which would have prescribed the drug MDMA combined with talk therapy for federal approval, instead requesting “an additional Phase 3 trial to further study the safety and efficacy” of the proposed treatment. We have previously covered that there is a growing movement advocating for the use of psychedelics such as psilocybin and others as possible therapy drugs for patients, and this rejection is another sign of the legal roadblocks that the movement faces as it seeks wider approval, but it may not be a fatal one. In a press release by the company seeking approval, Lykos Therapeutics, the company highlighted that the FDA had concerns over the reliability of the data submitted by the company and possible bias from the trial participants, which the company plans to address and possibly work with the FDA to alleviate their concerns to avoid further trials which could delay the treatment’s approval by a number of years. It is worth noting that the FDA had further questions about the dual treatment procedures and what effect the talk therapy had in the effectiveness of the treatment, since it is harder to quantify the effectiveness of that treatment versus a drug by itself. Dr. Michael Bogenschutz, director of the NYU Langone Center for Psychedelic Medicine, said “It’s frustrating to people who were hoping that this treatment would be found to be safe and effective and become available. I think we just need to take a deep breath and be patient and let the data accumulate to show more definitively, one way or the other, whether, in this particular case, MDMA can become a bona fide medical treatment for PTSD. This was just one decision point along the road.” At the same time, the journal Psychopharmacology retracted three articles about MDMA-assisted psychotherapy that were published between 2019 and 2020 over ethical violations by one of the therapists in the study and the authors failing to fully disclose “potential competing interests,” although 4 of the 5 authors of the studies that were reached for comment disagreed with the retraction and the other agreed with the retraction but disagreed with the wording of the notice. In either case, it is clear that drugs such as MDMA, which remains a Schedule I drug under the Controlled Substance Act with “no currently accepted medical use and a high potential for abuse,” face an uphill battle before their legal use will be sanctioned by the federal government. Anyone seeking this experimental new form of treatment risks violating US law and opening themselves up to criminal prosecution for the time being.