The US Food and Drug Administration (FDA) has refused to approve Lykos Therapeutics’ midomafetamine (MDMA) capsules for the treatment of post-traumatic stress disorder (PTSD) in adults.
In a complete response letter (CRL) for the new drug application (NDA), the federal agency said that the capsule cannot be approved based on the limited submitted data.
It further directed the company to initiate an additional Phase III trial to assess the safety and efficacy of MDMA.
The decision is aligned with the issues raised during the FDA Advisory Committee meeting in June 2024.
MDMA, an entactogen, is seen to support psychotherapy by reducing the brain’s fear response enabling the patients to become more resilient to painful memories.
Lykos conducted randomised, double-blind, placebo-controlled clinical trials to assess the effectiveness and safety of midomafetamine (MDMA) treatment in combination with psychological intervention.
It will continue with work with the FDA to address the concerns. The company is planning to seek a meeting with the agency and request a reconsideration and to discuss the recommendations for a resubmission.
Lykos Therapeutics CEO Amy Emerson said: “The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades.
“While conducting another Phase III study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the Advisory Committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature.”
Additionally, Lykos acknowledged the unique research questions that this novel therapy raises.
Notably, Lykos negotiated a Special Protocol Assessment (SPA) with the FDA in 2017. It also received Breakthrough Therapy designation on the same year.
In February 2024, the FDA accepted the company’s NDA for the MDMA capsules.
