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US FDA Staff Flags Concerns on MDMA-Assisted PTSD Treatment

Earlier today, staff from the U.S. health regulatory body expressed concerns regarding the interpretation of data from trials on the psychedelic drug MDMA…

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Earlier today, staff from the U.S. health regulatory body expressed concerns regarding the interpretation of data from trials on the psychedelic drug MDMA for treating post-traumatic stress disorder (PTSD). These concerns emerged ahead of an upcoming meeting of the agency’s advisory panel.

The comments have set the stage for in-depth discussions on the benefits and risks of this therapy by the U.S. Food and Drug Administration’s (FDA) advisory panel, scheduled for Tuesday. This marks the first time the FDA is reviewing the therapeutic use of MDMA, a substance commonly known as ecstasy or molly.

The FDA is seeking recommendations from its advisers on a capsule version of MDMA developed by Lykos Therapeutics, which was previously known as MAPS Public Benefit Corporation. While the FDA is not obliged to follow the advisers’ recommendations, it typically does.

A primary concern among the reviewers is that patients in the trials could discern whether they received MDMA or a placebo due to the drug’s distinct psychedelic effects. This recognition could potentially skew the assessment of the drug’s efficacy.

Despite these concerns, there is a significant unmet need for new PTSD treatments. PTSD, prevalent among individuals who have experienced traumatic events, including war veterans, often does not respond adequately to existing medications.

“Although this application presents a number of complex review issues, it does include two positive studies,” noted the FDA staff.

Currently, MDMA is illegal in the U.S., and the FDA has not yet approved its therapeutic use. Approval of this drug would represent a landmark development for psychedelic research, supporting claims that substances like MDMA can effectively treat mental health disorders and have therapeutic applications beyond their illicit use.

The FDA staff indicated that if MDMA were approved, Lykos would need to gather additional safety data, including liver function tests, due to instances of liver toxicity observed during the trials.

Lykos conducted studies on MDMA with a total of 194 patients across two late-stage trials. Each study involved three treatment cycles, with each cycle comprising one medication session and three subsequent talk therapy sessions conducted under healthcare provider supervision.

Patients who received MDMA doses in conjunction with therapy sessions demonstrated a significant reduction in PTSD symptoms compared to those who received a placebo. This reduction was measured through structured interviews designed to assess the severity of PTSD symptoms.

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