Lykos Therapeutics, a U.S.-based biotech firm, has expressed concern over the impact of the FDA’s August 9 decision to reject its New Drug Application (NDA) for midomafetamine (MDMA) as a treatment for post-traumatic stress disorder (PTSD) in adults. This ruling is seen as a pivotal moment for the emerging psychedelics industry, as the FDA issued a complete response letter (CRL) requesting an additional Phase III trial to further substantiate the drug’s safety and efficacy.
In response to the setback, Lykos plans to reorganize significantly, which will include a workforce reduction of approximately 75%. The streamlined team will concentrate exclusively on advancing midomafetamine’s clinical development, managing medical affairs, and liaising with the FDA. Notably, Dr. Rick Doblin, founder and president of the Multidisciplinary Association for Psychedelic Studies (MAPS) and a prominent advocate for psychedelic research, has resigned from the Lykos board. He stated, “I can speak more freely as a public advocate by resigning from the Lykos Board.”- Flcube.com
