The US Food and Drug Administration (FDA) has not approved an application by Lykos Therapeutics to use MDMA, also known as ecstasy, for treating post-traumatic stress disorder (PTSD). The FDA has requested a further Phase 3 trial to examine the safety and effectiveness of the treatment more closely.
Lykos Therapeutics had submitted positive results from two advanced clinical trials which combined MDMA with talk therapy to treat PTSD. These trials involved around 200 participants who underwent three eight-hour sessions of MDMA-assisted therapy under the supervision of two therapists, spaced about a month apart with additional talk therapy.
MDMA, a psychoactive drug known for enhancing feelings of emotional closeness and openness, is currently classified as a Schedule I controlled substance, indicating it has a high potential for abuse and no accepted medical use. This classification complicates its approval for medical purposes.
Despite the novel approach’s potential, an independent FDA advisory committee recently voted against the treatment, pointing to concerns over trial integrity and the clarity of results. The committee particularly noted incomplete safety data and possible biases in the efficacy results. They also questioned the individual impact of the talk therapy component, which is outside the FDA’s regulatory scope.
Lykos announced its intention to meet with the FDA to address these issues and to plan for the additional trial, which could take years. The company remains hopeful about resolving the FDA’s concerns and eventually gaining approval for the treatment.
Public Citizen, a consumer advocacy group, supported the FDA’s decision, emphasizing the need for rigorous evidence of safety and effectiveness in approving new drugs. However, some veterans’ groups expressed disappointment, highlighting the potential benefits of MDMA-assisted therapy and criticizing the FDA for not considering a more cautious, conditional approval that could allow further data collection.
About 5% of US adults experience PTSD annually, with existing treatments often limited in effectiveness. The rejection by the FDA thus underscores the challenges in integrating psychedelic drugs into mainstream mental health treatments despite their promising potential.
