D-Keine/E+ via Getty Images This article was updated at 535p ET with results of the second vote. A panel of advisors to the U.S.
FDA declined to endorse Lykos Therapeutics' application to market to psychedelic drug MDMA, also known as ecstasy, as a treatment for post-traumatic stress disorder. The Psychopharmacologic Drugs Advisory Committee held votes on two questions. The first dealt was the drug's efficacy in PTSD, while the second asked whether the benefits of MDMA with an FDA risk evaluation and mitigation strategy (REMS) outweigh its risks for PTSD.
The first vote was 9-2 that data did not demonstrate MDMA is effective. The second vote was 1-10 against. Lykos has proposed a treatment regimen of three sessions of MDMA administration along with psychotherapy for a single 4-month course of treatment.
In briefing documents provided ahead of the meeting, FDA scientists said that based on clinical trial data, patients "experience rapid, clinically meaningful, durable improvement in their PTSD symptoms." However, they also cautioned that "several factors make these data challenging to interpret and complicate the benefit-risk assessment for this application. Chief among these factors is the nature of the treatment itself.
First, [MDMA] produces profound alterations in mood, sensation, suggestibility, and cognition. As a result, studies are nearly impossible to blind." FDA reviewers also expressed concerns about safety.
"For example, the cardiac safety profile of [MDMA] is not .
