FDA Sets September Meeting To Discuss Psychedelic And Other Treatments For PTSD

The U.S. Food and Drug Administration (FDA) has scheduled a public meeting for September 6, 2024, to gather input on potential new treatments for post-traumatic stress disorder (PTSD), including the use of psychedelic drugs. This meeting marks a significant step in the ongoing exploration of psychedelics as viable therapies for mental health conditions, particularly PTSD, a disorder that affects millions of people, including many veterans.

Lykos Therapeutics' Setback

The FDA’s decision to hold this “hybrid public meeting,” offering both virtual and in-person attendance options, comes shortly after the agency’s surprising rejection of a new drug application from Lykos Therapeutics. The application sought approval for an MDMA-based therapy for PTSD, a treatment that has shown promise in various studies but was unexpectedly halted by the FDA earlier this month. The rejection led Lykos to reduce its workforce by 75% and initiate a reorganization plan, underscoring the high stakes involved in the regulatory process for psychedelic treatments.

Public Commentary On Psychedelic Therapies

According to the FDA’s notice, the upcoming meeting will include a panel discussion featuring federal partners, aimed at exploring efforts to accelerate the development of treatments for PTSD, including those involving psychedelics. The agency is opening the floor to public commentary, inviting veterans, individuals with PTSD experience, patient advocates, researchers and drug developers to participate.

Limited Speaking Opportunities For Meeting Participants

However, the opportunity to speak at the meeting is limited. As Green Market Report writes, only 30 participants will be selected to present their views, with each allotted just three minutes. Those interested in speaking must register by September 3 and the FDA will notify the chosen participants on September 4. For those unable to attend or who are not selected, written comments can be submitted until September 20.

Potential Impact On Psychedelic Research And Regulation

The meeting highlights the growing interest in psychedelic treatments for PTSD, an area that has gained momentum in recent years due to the potential of substances like MDMA and psilocybin to offer relief where traditional therapies have often fallen short. The FDA’s willingness to engage in public discourse on the matter signals a shift in the regulatory landscape, one that could pave the way for more open discussions and eventual approval of psychedelic therapies.

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