FDA Panel Advises Against MDMA As Treatment For PTSD
Although advisers noted the promise of psychedelic use for patients who suffer trauma, they agreed clinical trials so far haven't yielded convincing results. California-based Lykos Therapeutics said it would continue to work with the FDA to ease doubts.
CNN:
FDA Advisers Vote Against First MDMA Therapy To Treat PTSD
A federal advisory committee on Tuesday voted overwhelmingly against of the use of MDMA, commonly known as ecstasy, as a treatment for post-traumatic stress disorder. The novel treatment has the potential to transform a field with significant need, but the committee had concerns about the integrity of the particular trials up for review. After hearing presentations from the US Food and Drug Administration, treatment sponsor Lykos Therapeutics and members of the public, the independent committee voted on recommendations to be made to the FDA. (McPhillips, 6/4)
Vox:
"I Don't Think We're Quite There Yet": Why An FDA Advising Committee Voted Against MDMA For PTSD
Testimony submitted to the FDA by a participant in a MAPS phase 3 trial reportedly claimed that at least three people who received MDMA during the trial reported a worsening of suicidality in the ensuing weeks — a detail that didn’t show up in the published journal articles about the trial (Lykos responded that all adverse events were reported to the FDA). Further, the same participant alleges that their trial therapists repeatedly told them that they were “helping make history,” and reminded them that their “responses and behaviors during and after the trial could jeopardize legalization.” (Jarow, 6/4)
Politico:
The Psychedelic Medicine Revolution Just Took A Big Loss
In a statement after the advisory committee votes, Lykos CEO Amy Emerson said the firm was disappointed but “committed to continuing to collaborate with the FDA with their ongoing review.” She added that Lykos would work with the FDA to answer questions raised at the committee meeting. She said Lykos was in ongoing discussions with the FDA about a risk evaluation and mitigation strategy program that would seek to reduce the chance of adverse events stemming from its treatment. (Schumaker, 6/4)
The Washington Post:
What To Know About PTSD As FDA Weighs MDMA Therapy
PTSD is a mental health condition that can develop after a shocking, scary or dangerous event. The FDA is deciding whether MDMA, better known as ecstasy, can help. (Masih and Jeong, 6/5)
