What happened
A Food and Drug Administration advisory panel on Tuesday voted against approving the use of MDMA, a psychedelic drug commonly known as ecstasy or molly, to treat post-traumatic stress disorder. The committee voted 9-2 that data submitted by Lykos Therapeutics did not prove that MDMA combined with talk therapy was effective at treating PTSD.
Who said what
Panel members “praised the promise” of MDMA to treat PTSD, which hasn’t seen a new drug in nearly 25 years, but “struggled with gaps in the research data” and the “potential for abuse,” The Washington Post said. Lykos’ two late-stage trials found vast improvements in a sizable majority of participants who got MDMA, but its data was “uncommonly messy,” and the study participants were largely able to tell if they took a placebo or ecstasy, marring the results.
Lykos CEO Amy Emerson said the company is “disappointed in the vote” but will continue working with the FDA to meet the “urgent need for new, effective and accessible therapies” for the 13 million Americans living with PTSD.
What next?
The FDA expects to issue its final decision in mid-August.