FDA Sets Date for Advisory Committee Meeting for Midomafetamine for PTSD

The FDA will convene a meeting of the Psychopharmacologic Drugs Advisory Committee on June 4, 2024, to review data for midomafetamine to treat patients with post-traumatic stress disorder (PTSD). PTSD is a mental health condition affecting about 13 million Americans each year, yet currently available treatments provide only modest efficacy; there are high treatment discontinuation rates.

Developed by Lykos Therapeutics, midomafetamine is 3,4-methylenedioxymethamphetamine (MDMA) — commonly known as ecstasy — a class of psychoactive compounds. The FDA’s target action date is Aug. 11, 2024. If approved, this would be the first psychedelic-assisted therapy for post-traumatic stress disorder.

“This will be the first MDMA-assisted therapy and psychedelic-assisted therapy to be reviewed by the Psychopharmacologic Drugs Advisory Committee, a significant milestone in the field of psychedelic medicine, resulting from decades of clinical research and advocacy,” Amy Emerson, CEO of Lykos Therapeutics, said in a news release.

IPD Analytics LLC predicts the wholesale acquisition cost will be between $5,000 and $10,000 per drug course and the drug will be administered by physicians.

The committee will discuss the overall benefit-risk profile of the product, including the potential public health impact. Committtee members will review results from two phase 3 studies (MAPP1 and MAPP2) evaluating the efficacy and safety of MDMA.

MAPP1 and MAPP2 both met the primary endpoint as measured by the change from baseline in Clinician-Administered PTSD Scale for DSM-5 and the key secondary endpoint of improvement in functional impairment associated with PTSD.

Results from MAPP2 were published in Nature Medicine in September 2023. In the trial, 45 of 52 (86.5%) patients treated with midomafetamine achieved a clinically meaningful benefit, and 37 of 52 (71.2%) patients no longer met criteria for PTSD by study end.

In both trials, treatment was not significantly affected by disease severity, risk of hazardous alcohol or substance use disorder, severe adverse childhood experiences or dissociative subtype. Both studies had a low drop out rate: 1.9% for the those treated with midomafetamine in MAPP2.

No serious adverse events were reported in the MDMA group in both studies. Common treatment-related adverse events included mild increases in blood pressure and pulse. Midomafetamine did not appear to increase the risk of suicidal ideation.

In January 2024, a new reimbursement code went into affect for psychedelic therapies. The American Medical Association approved in May 2023 a Current Procedural Terminology (CPT) III code for psychedelic therapies.

Midomafetamine is also being studied in patients with PTSD in Europe. Lykos recently announced that it had completed a phase 2 study (MP18) in Europe. The study included 21 patients treated in sites in the Netherlands, United Kingdom, Czech Republic, Germany, and Norway. The study included an optional fMRI sub-study assessing changes in brain activity in subjects with PTSD.

“There is an urgent need for new and effective evidence-based treatments for PTSD in Europe where the reported PTSD prevalence is up to 6.7%,” Eric Vermetten, M.D., Ph.D., professor of psychiatry at Leiden University Medical Center and lead investigator of the study, said in a news release.