The U.S. Food and Drug Administration’s decision to reject MDMA-assisted therapy for post-traumatic stress disorder sent ripples through the psychedelic industry.

The FDA issued a complete response letter to Lykos Therapeutics on Friday for its new drug application for midomafetamine capsules, an MDMA-assisted therapy for PTSD in adults. The agency requested another Phase 3 trial to further study the drug’s safety and efficacy. The decision came just before the August 11 deadline for the agency’s ruling on the application.

The decision follows a contentious FDA Advisory Committee hearing in June, where panelists recommended against approval.

Study concerns

For the most part, official responses from psychedelic companies and other interested parties were relatively diplomatic, ranging from disappointment to cautious optimism about future prospects as the push to legalize continues.

Still, some industry observers have raised concerns about the process, claiming that “unverified accusations” from activist groups and a report by the Institute for Clinical and Economic Review (ICER) may have influenced the committee’s decision. Critics argued that Lykos was not given adequate time to address what they characterize as misinformation discussed during the hearing.

The controversy deepened when a prominent medical journal retracted three MDMA-related studies just a day after the FDA’s decision. The journal cited “protocol violations amounting to unethical conduct” at one of the study sites, as well as issues with disclosure of potential conflicts of interest.

“Several of the authors are affiliated with either the Multidisciplinary Association for Psychedelic Studies (MAPS) or MAPS Public Benefit Corporation (MAPS PBC), a subsidiary that is wholly owned by MAPS,” the notices stated. “As is stated in the Funding declaration, MAPS fully funded and provided the MDMA that was used in this trial, and MAPS PBC organised the trial.”

Allison A. Feduccia, a researcher who contributed to all three studies, accepted the journal’s decision but took issue with “the wording of the retraction notice.” Several other authors, however, openly disagreed with the retractions, including Rick Doblin, founder and president of MAPS.

Lykos also disagreed with the journal retractions. The company in a written response said that it “believes the identified issues should have been addressed through corrections” rather than retractions.

Lykos emphasized that “these are not the efficacy data that was submitted to the FDA, and this was not the basis for their decision to issue a Complete Response Letter.”

The company acknowledged a lapse in disclosure regarding a 2015 Phase 2 study.

“Originally, the publication authors chose to retain these data for sake of completeness, but that should have been disclosed to the journal and was not,” Lykos stated. They added, “We did not disclose the violations to the journal itself, an additional step we should have taken and regret not doing.”

Lykos said it has filed an official complaint with the Committee on Publication Ethics (COPE) “to review the process through which the journal came to this decision.” The company maintains that the articles “remain scientifically sound and present important contributions to the study of potential treatments for PTSD.”

Reactions

Here’s a sampling of how industry leaders responded to the news:

Rick Doblin, founder and president, Multidisciplinary Association for Psychedelic Studies (MAPS)

“MAPS and our supporters have been advocating for the development and supporting the FDA-approved research of MDMA-assisted therapy for more than 38 years; MAPS will continue working towards safe, legal access to this therapy for the more than 350 million people living with PTSD worldwide.

“Our collective commitment to MDMA-assisted therapy remains unwavering. MAPS remains fully focused on supporting culturally appropriate research, rigorous science, and drug policy reform that empowers citizen advocacy in all areas of the world including those with high incidences of trauma and limited resources.”

Amber Capone, CEO and co-founder, Veterans Exploring Treatment Solutions (VETS)

“While this is not the victory for psychedelic-assisted therapy we hoped for, we know that no battle is won without facing adversity. This development is merely another hurdle in our ongoing mission to end the veteran suicide epidemic.

“Roughly 20 veterans die by suicide every day. A recent study estimates the number could be as high as 44. This is unacceptable. The potential of MDMA-assisted therapy to help veterans heal from post-traumatic stress disorder (PTSD) remains paramount. We will not allow bureaucratic processes to deter us from advocating for approval of this transformative treatment.”

Domenic Suppa, COO, Rose Hill

“Although the FDA’s issuance of a CRL for the new drug application for MDMA-assisted therapy may initially present a hurdle, we at Rose Hill will not deviate from our efforts to continue research into these groundbreaking psychedelic treatments. Jamaica has been on the right side of history and permits legal and regulated access to psychedelics. Through our psychedelic-assisted retreats in Jamaica, we have seen the impact of psychedelic medicines and integrated therapy on individuals, particularly veterans.

“Our dedication to ensuring safe access to psychedelic-assisted therapies is as pressing as ever, and we are committed to facilitating access to these therapies for those in need. We are strongly positioned to support the FDA with our research partnerships and practical insights. Our commitment to individuals who are seeking efficacious mental health solutions remains resolute.”

Joe Perekupka, CEO, Freespira

“The FDA’s recent decision on MDMA underscores the complex landscape of mental health treatments. At Freespira, we recognize the urgent need for additional effective PTSD treatments but support the FDA’s commitment to patient safety when reviewing potential new treatments.”

Payton Nyquvest, founder and CEO, Numinus Wellness

“While this is a blow to all the incredibly positive and encouraging work that has been done to advance safe access to psychedelic therapy, which MAPS and Lykos have led the charge for, we remain unwavering and committed to doing all we can to make these important therapies available for all those suffering who need it most. We’re confident that further study will continue to show the efficacy of MDMA, and with many psychedelic compounds at the late stages of research, the pipeline of treatments to address severe conditions remains strong.”

Liam Bedard, executive director, PsyCan

“While the FDA’s decision is a setback for the approach taken by Lykos, this result cannot be generalized to MDMA-assisted therapy or psychedelic-assisted therapies at large. There are dozens of ongoing studies investigating MDMA, novel MDMA formulations, and a range of other psychedelic medicines as therapies for a variety of indications in clinical trials overseen by academic institutions and companies here in Canada and around the world.

“Several psychedelic drugs have received FDA designations enabling additional consultation on clinical design earlier in their respective trial phases, which are not precluded by the issues raised in Lykos’ case.”

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