Amy Emerson is stepping down on the heels of the FDA last month rejecting Lykos Therapeutics’ MDMA-based therapy for post-traumatic stress disorder and the company laying off three-quarters of its staff.
Tag Archive for: Lykos Therapeutics
Psychedelic drug developers are undeterred by the FDA’s Complete Response Letter for Lykos’ MDMA therapy for PTSD, and experts expect the company will ultimately obtain approval.
Lykos Therapeutics will lay off 75% of its workforce, or about 100 employees, and founder Rick Doblin will leave the board, the company said on Thursday, days after the U.S. FDA declined approval for its MDMA-based PTSD treatment.
A day after the regulator denied approval of Lykos’ MDMA-assisted PTSD therapy, a medical journal pulled three studies related to the use of the psychedelic in the indication.
While an FDA advisory committee voted overwhelmingly against approving the psychedelic therapy, experts suggest it may still have a chance.
The U.S. health regulator’s staff reviewers raised concerns related to interpretation of results from trials for Lykos Therapeutics psychedelic drug MDMA to treat post-traumatic stress disorder.
The agency’s panel of independent advisers will on June 4 deliberate whether they should recommend approval for the first MDMA-assisted therapy for post-traumatic stress disorder, Lykos Therapeutics stated.