US FDA widens probe of MDMA-based drug studies, WSJ reports

[August 24, 2024]  (Reuters) - The U.S. FDA is ramping up its investigation of the clinical trials that tested an MDMA-based therapy, the Wall Street Journal reported on Friday, citing people familiar with the matter.

The Food and Drug Administration investigators this week interviewed four people about the clinical trials sponsored by Lykos Therapeutics, the report said.

Lykos did not immediately respond to a Reuters request for comment, while the FDA could not immediately be reached.

Commonly known as ecstasy or molly, MDMA has long been seen by advocates as a potential treatment for mental health disorders and to have therapeutic applications beyond its illicit use.

Lykos had said earlier this month the FDA declined to approve the therapy based on the mind-altering drug for patients with post-traumatic stress disorder and asked the company to conduct an additional late-stage trial to further study its safety and efficacy.

The company had then said it plans to request a meeting with the FDA to ask for reconsideration of the decision and to discuss the agency's recommendations for a resubmission seeking approval for the MDMA capsules.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

PTSD, a disorder caused by very stressful events, affects 13 million Americans and is commonly associated with war veterans. But natural disasters, abuse or other trauma may also trigger the condition in civilians.

Last week, Lykos said it would lay off 75% of its workforce, or about 100 employees, and founder Rick Doblin would leave the board.

(Reporting by Manya Saini in Bengaluru; Editing by Shilpi Majumdar)

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