Lykos Therapeutics’ PTSD Treatment Receives Rejection from the FDA

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Lykos Therapeutics (Lykos) has received a rejection from the US Food and Drug Administration (FDA) regarding its midomafetamine (MDMA) treatment for post-traumatic stress disorder (PTSD). Upon rejecting the treatment due to the “data submitted to date,” the FDA asked Lykos to conduct another Phase III trial. Lykos is expected to ask the FDA to reconsider its decision.

Previously, the FDA’s Psychopharmacologic Drugs Advisory Committee (AdCom) published its negative opinion on the treatment in June. The capsules were involved in two votes. The first found that “available data did not show MDMA’s efficacy in PTSD,” which received a 9-2 vote. While the second found “the benefits of the drug do not outweigh its risks,” which received a 10-1 vote.

Regarding AdCom’s opinion, Lykos released the following statement:

“The company and other stakeholders have expressed concerns around the structure and conduct of the AdCom meeting, including the limited number of subject matter experts on the panel and the nature of the discussion, which at times veered beyond the scientific content in the briefing documents.”

Following the FDA’s rejection, Lykos plans to request a meeting with the organisation. Amy Emerson, Chief Executive Officer of Lykos has stated that “While conducting another Phase III study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the Advisory Committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature."

The evidence that Lykos presented during the FDA AdCom meeting includes positive data from two Phase III trials, MAPP1 (NCT03537014) and MAPP2 (NCT04077437). Concerns regarding the trial design, especially its functional blinding, were raised. However, Lykos insists that it took steps to minimise the impact of functional blinding, saying, “The weight of evidence suggests a very low likelihood that the observed MDMA effect can be adequately explained by functional unblinding”.