The FDA has declined to approve a therapy utilizing 3,4-Methylenedioxymethamphetamine for patients with post-traumatic stress disorder, citing insufficient data for approval, according to developer Lykos Therapeutics.

This decision aligns with the FDA's expert panel's previous vote. During the panel's June meeting, advisers raised concerns about the clinical trials conduct, including inadequate documentation of potential substance abuse among participants, issues with trial design, and the need for more robust evidence.

The FDA has requested an additional phase 3 trial to further evaluate the drug's safety and efficacy. Lykos plans to seek a meeting with the FDA to discuss potential reconsideration and recommendations for resubmission.

The proposed treatment involved 3,4-Methylenedioxymethamphetamine (MDMA) capsules administered in conjunction with psychotherapy sessions conducted by licensed mental health providers. Lykos reported enrolling over 190 patients in two phase 3 trials, comparing MDMA-assisted therapy to placebo. The company claimed a significant reduction in post-traumatic stress disorder (PTSD) scores for most subjects receiving the active treatment compared to placebo.

Walter Dunn, MD, PhD, assistant professor at UCLA's Department of Psychiatry, noted that while the decision is disappointing for some, the FDA's request for additional data aims to improve understanding of the treatment.

The Institute for Clinical and Economic Review had previously reported insufficient evidence to demonstrate the benefits of MDMA-assisted PTSD treatment.

This decision occurs amid broader research into psychoactive compounds for various mental health conditions, including PTSD, anxiety, and depression. The FDA's stance on this particular application may not necessarily impact other psychedelic research programs, as methodologies and trial designs vary across studies.