The Pearl Psychedelic Institute is deeply disappointed in the decision that FDA rendered at the end of the day on Friday, August 9th which stated that there was not adequate data in Lykos’ NDA to make a decision about approving midomafetamine, the company’s capsule form of MDMA being evaluated for the treatment of PTSD. The full explanation from FDA has not been released to any organization but Lykos at this point, but Lykos plans to appeal the decision and ask FDA to reconsider. At this point, FDA is stating that another Phase 3 study will be required which would mean Lykos having to raise tens of millions of dollars for a study that will take years. However, the worst part of this outcome is that millions of people suffering from the life-threatening effects of PTSD (including veterans, domestic violence and abuse survivors) will not have legal access to this treatment for the foreseeable future.
We at the Pearl are aware of the criticisms that were leveled at Lykos, MAPS, and the design and conduct of the studies by those detractors who seem determined to delay or avoid the approval of MDMA-assisted therapy for PTSD for various reasons. It is difficult to understand the criticisms about the study design and conduct when FDA was closely partnering with Lykos for more than a decade to effectively address these criticisms, especially throughout Phase 3. Although the sexual misconduct of one treatment team at one Canadian site during Phase 2 was egregious and unforgivable, this should not detract from the legitimacy of the results of the other hundreds of patients at the other sites that received this treatment in Phase 2 and Phase 3. The research indicates that MDMA-assisted therapy likely provides a safe and effective treatment for chronic, treatment-resistant PTSD. This means that when conventional therapies and medications have been largely ineffective, MDMA-assisted therapy demonstrated an ability to catalyze healing.
MDMA is not a new compound. It was first synthesized in 1912 and mental health practitioners first learned of its healing abilities in the late 1970s and by using it in various settings, it was noted that MDMA, when administered in the context of clinical supervision and psychotherapy, could profoundly alter the damage done by traumatic experiences. MDMA has been widely used recreationally since the mid-1980s and if MDMA could ignite an epidemic of abuse (like oxycontin, which was approved by FDA in 1995), such an epidemic would have occurred long ago.
It is also important to address the criticism about the psychotherapy component that Lykos used to facilitate the healing potential of MDMA. There are no currently accepted “evidence-based” psychotherapies for psychedelic work because these compounds have been Schedule 1 for over 50 years which means the ability to research them has been pretty close to impossible. The “evidence-based” psychotherapies currently available were developed for conventional interventions and it’s obvious that psychedelic-assisted therapy is entirely different. If there was such a thing as an “evidence-based” psychedelic-assisted therapy, it would closely resemble Lykos’ non-directive, supportive approach because this is essentially what was shown to be most effective when psychedelic research was in its heyday in the 1950s and 1960s.
It is sincerely hoped that FDA will allow Lykos to appeal for a reconsideration of this puzzling and disappointing decision. Given the fact that FDA itself was closely involved with the research design and the supervision of the research, it seems that the conservative approach would be to grant midomafetamine conditional approval and further research be conducted as a Phase 4 study which would be an effective way to gather further safety and efficacy data while beginning to make this treatment available to those suffering from PTSD. By doing this, we could continue to study and refine this treatment so that we could better learn how to use this powerful healing intervention safely, responsibly and effectively.
In the meantime, the Pearl Psychedelic Institute will continue to provide training and community education about psychedelic-assisted therapy as well as ketamine-assisted psychotherapy (KAP) and psychedelic integration services to those curious about these modalities and those seeking healing. Now is the time to stand up and make your voices heard about the need for new approaches to mental health treatment. Please consider making a donation to us so that we can continue to help push this important mission forward.
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