FDA Panel Votes Against MDMA for PTSD Treatment Amid Data Concerns and Allegations

The potential approval of midomafetamine, a drug also known as MDMA, to treat post-traumatic stress disorder (PTSD) encountered a significant setback on Tuesday. A panel of the Food and Drug Administration's (FDA) external advisors voted against the treatment, with nine voters opposing and only two in favor.

Concerns Over Data and Effectiveness

The committee's decision was based on the question of whether there was sufficient data to demonstrate the drug's effectiveness in treating PTSD. Midomafetamine, commonly known as ecstasy in illegal street drug use, faced scrutiny regarding its therapeutic benefits.

Impact on FDA's Decision

While the FDA is not bound to adhere to the committee's votes, it typically considers the panel's feedback. In some cases, pharmaceutical companies are required to conduct additional studies before resubmitting their drugs for FDA approval. The FDA is anticipated to make a final decision on the current submission for trialing MDMA by Lykos Therapeutics on August 11.

Panelists' Concerns and Criticisms

During the Psychopharmacologic Drugs Advisory Committee's meeting, several panel members raised concerns about the inadequacies in the study data provided by Lykos Therapeutics. Questions were raised about the study designs, results, and the drugmaker's failure to collect requested data. Additionally, there were apprehensions about the sustainability of PTSD treatment with midomafetamine.

Controversies and Company's Response

Claims were made about therapists potentially abusing patients during drug trials while under the influence of MDMA. Furthermore, the Institute for Clinical and Economic Review highlighted allegations that therapists might have discouraged negative patient reports, potentially biasing the results. In response, Lykos Therapeutics assured the committee that it had thoroughly investigated the accusations and had implemented measures to prevent such misconduct. The company also pledged to collaborate with the FDA to establish training and safeguards to protect vulnerable patients post-approval.

FDA's Response and Ongoing Inspections

The FDA refrained from addressing specific allegations raised by the committee, stating that inspections regarding the claims were ongoing. Dr. Teresa Farchione from the FDA informed the committee that the reports were considered unverified until the FDA conducted its own inspections, urging the committee not to factor them into their votes.