A few months from now, the U.S. Food and Drug Administration (FDA) will be deciding whether MDMA can be prescribed as a treatment for post-traumatic stress disorder (PTSD”. MDMA, which is commonly known as ecstasy, is currently classified as a Schedule I drug under the Controlled Substances Act.
The agency’s approval of the drug’s use would be a significant breakthrough, particularly for the movement that has championed for psychedelic drugs to be used in managing a range of mental health conditions. On the other hand, FDA rejection of the drug’s use for these conditions would also be a major setback for the movement.
Various trials have demonstrated the drug’s potential for managing symptoms of post-traumatic stress disorder, with testimonies from some individuals who took part in the trials describing the therapy as transformational.
Despite this, some concerns are threatening to hinder the drug’s path into mainstream healthcare. A draft report released about two months ago by the Institute for Clinical and Economic Review (ICER) raised significant concerns about the validity of the findings from trials involving the drug. ICER is a nonprofit that assesses drug prices and clinical trials.
In its report, the nonprofit acknowledged that the data suggested that MDMA would be a crucial addition to treatment options for post-traumatic stress disorder. That said, the report questioned whether the findings told the whole story.
The report was accompanied by a citizen petition to the Food and Drug Administration, with the group of concerned individuals claiming possible ethical violations and misconduct that could compromise research on the psychedelic drug. In its petition, the group asked that the FDA arrange a public meeting to address the issues raised. If these claims are true, the likelihood of MDMA receiving approval from the FDA may reduce greatly.
Organizations at the forefront of research into MDMA also have a lot to lose, among them Lykos Therapeutics and the Multidisciplinary Association for Psychedelic Studies (MAPS). Lykos funded the clinical trials on the psychedelic drug, whose results are included in the company’s application to the federal agency requesting approval to market the medication for therapy-assisted post-traumatic stress disorder treatment.
Scientists and clinicians who were part of the trials have refuted accusations that their clinical data isn’t sound. The lead author of the published findings from MAPS’ phase 3 trials, Professor Jennifer Mitchell of the University of California-San Francisco, stated that she would support the findings.
The trials assessed the effectiveness of MDMA-assisted therapy in treating moderate and severe post-traumatic stress disorder. In their report, the researchers noted that roughly 71% of participants who received the MDMA treatment didn’t meet the diagnostic criteria for post-traumatic stress disorder.
Startups such as atai Life Sciences N.V. (NASDAQ: ATAI) that are conducting their own psychedelic drug-development programs will be watching how these issues leveled against the studies conducted by MAPS will play out and how the FDA rules about the MDMA new drug application.
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