FDA Advisors Reject MDMA-Based Therapy For PTSD

NPR reports:

A panel of experts advising the Food and Drug Administration on the use of the psychedelic MDMA for post-traumatic stress disorder found on Tuesday that the available evidence fails to show that the drug is effective or that its benefits outweigh its risks.

It represents a major setback for proponents of the drug and its sponsor Lykos Therapeutics, potentially jeopardizing FDA approval of the treatment.

Following public comment and discussion, the panel voted 9-2 that MDMA – in combination with talk therapy – is not effective for treating PTSD. And they voted 10-1 that the benefits of MDMA treatment don’t outweigh its risks.

Read the full article.

A key FDA advisory committee rejected the use of a psychedelic drug to help patients struggling with PTSD, questioning the trials and its effectiveness.

The FDA must now decide whether it will follow suit and reject the use of what’s known as MDMA.@milesobrien has more. pic.twitter.com/Taf2iZVj5u

— PBS NewsHour (@NewsHour) June 4, 2024