FDA Staff Questions Safety of MDMA Treatment for PTSD

FDA staff raised concerns about the available safety data and limitations in the study design for midomafetamine (MDMA) to treat post-traumatic stress disorder (PTSD) in briefing documents released ahead of an FDA Psychopharmacologic Drugs Advisory Committee (PDAC) meeting.

If eventually approved by the agency, Lykos Therapeutics’ MDMA could become a first-in-class treatment for PTSD, which affects an estimated 5% of the U.S. population in any given year, according to the Veterans’ Administration National Center for PTSD. While PTSD can be treated with selective serotonin reuptake inhibitors (SSRIs), FDA staff noted that response rates with these drugs rarely exceed 60%, and typically less than 20% to 30% of patients achieve full remission.

“Thus, there remains an unmet need for additional options for safe and effective therapies to treat PTSD,” the FDA reviewers wrote.

The agency will ask the PDAC to discuss several major points during the June 4 meeting. The committee will first focus on efficacy, including the potential effect of functional unblinding on the interpretability of efficacy results, the durability of effects, and the role of psychotherapy in the treatment paradigm. It will assess the adequacy of the safety characteristics of MDMA, and review the potential for patient impairment or serious harm from treatment. In addition, the PDAC will weigh in on a proposed risk mitigation strategy to prevent serious patient harms related to MDMA treatment.

Two phase III trials conducted have assessed the efficacy and safety of MDMA in PTSD. Both studies, MAPP1 and MAPP2, were randomized, double-blind, placebo-controlled trials that included 91 and 104 participants with PTSD, respectively. Participants received three dosing sessions of MDMA with additional psychological support sessions before and after dosing.

In both trials, the MDMA arm experienced statistically significantly greater improvement in PTSD symptoms based on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score.

In MAPP1, the MDMA and psychotherapy group saw an average drop in CAPS-5 score of 24.4 points, while those receiving psychotherapy alone saw an average drop of 13.9 points. In MAPP2, patients in the MDMA arm had a least-squares mean change of -23.7 in CAPS-5 score compared with -14.8 for those in the placebo arm (P
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