An independent advisory panel of the Food and Drug Administration rejected the use of MDMA-assisted therapy for post-traumatic stress disorder on Tuesday, highlighting the unparalleled regulatory challenges of a novel therapy using an illegal drug commonly known as Ecstasy. Before the vote, members of the panel raised concerns about the designs of the two studies…
The Food and Drug Administration is weighing whether to approve the use of MDMA, also known as Ecstasy, for treatment of post-traumatic stress disorder. An independent advisory panel of experts will review studies on Tuesday and is expected to vote on whether the treatment would be effective and whether its benefits outweigh the risks. The…
The Food and Drug Administration on Friday raised concerns about the health effects of MDMA as a treatment for post-traumatic stress disorder, citing flaws in a company’s studies that could pose major obstacles to approval of a treatment anticipated to help people struggling with the condition. The agency said that bias had seeped into the…
