A recent advisory panel to the Food and Drug Administration (FDA) has cast significant doubt on the potential approval of MDMA-assisted therapy for post-traumatic stress disorder (PTSD)
The expert panel, after a thorough review and public discussion, concluded that the current evidence does not support the effectiveness of MDMA for treating PTSD nor does it justify the potential risks associated with its use.
Setback for Lykos Therapeutics
The panel’s decision marks a major setback for Lykos Therapeutics, the company sponsoring MDMA’s FDA approval. Despite presenting data from two randomised controlled trials indicating positive outcomes, the panel found the evidence insufficient. In one study, 67% of participants receiving MDMA no longer met the criteria for PTSD, compared to 32% in the placebo group. However, the panel remained unconvinced about the reliability and sufficiency of these findings.
Key concerns highlighted by the FDA staff and panel members included significant uncertainties and gaps in the data, questions about the drug’s potential for abuse, and a lack of robust evidence supporting the psychological methods used in conjunction with the drug. Moreover, FDA scientists mentioned ongoing investigations into some claims raised in external reports and petitions, although specific details were not disclosed.
The panel’s scepticism was further fueled by issues with the long-term data presented by Lykos. A follow-up observational study suggested that MDMA’s benefits could last up to six months, but this study faced scrutiny due to a high dropout rate and some participants seeking additional therapy or using illicit drugs during the study period.
The need for new PTSD treatment
Public comments during the meeting underscored the urgent need for new PTSD treatments, with some patients who participated in the trials describing the therapy as transformative. However, these personal testimonies did not sway the panel’s overall assessment.
Critics also voiced serious ethical concerns, pointing to past allegations of misconduct during the trials. There have been documented instances of inappropriate behaviour by therapists, raising fears that widespread use of MDMA in therapeutic settings could lead to similar issues.
A recent report from the Institute for Clinical and Economic Review concluded that there was insufficient evidence to determine the overall benefit of MDMA-assisted therapy, further questioning the integrity of the trial data.
Despite these setbacks, Lykos Therapeutics maintains its view on the validity of its data and continues to defend the safety and efficacy of MDMA-assisted therapy. However, given the panel’s strong recommendations and the myriad of concerns raised, the path to FDA approval for MDMA as a PTSD treatment appears fraught with challenges.
