What is the framework for approval?
In 2017, the FDA granted “breakthrough” status to MDMA-assisted therapy. Status, the recognition of a drug’s therapeutic promise, aims to shorten regulatory times.
The original application was sponsored by the nonprofit Multidisciplinary Association for Psychedelic Studies, which earlier this year created a for-profit entity, Lykos Therapeutics, to commercialize MDMA if it gained approval. FDA approval.
The request presents an unusual challenge for the FDA, which typically does not regulate drug treatments associated with talk therapy, an essential part of Lykos’ regimen for treating post-traumatic stress disorder.
On June 4, an expert advisory panel will review Lykos’ clinical data, along with public comments and staff analyses, to make recommendations to the FDA. The agency often follows the group’s suggestions, and a final decision is expected by mid-August.
What do therapeutic sessions involve?
According to a report published in Nature Medicine, about 200 patients in the Lykos clinical trials underwent three sessions, lasting eight hours each, in which about half were given MDMA and the other half a placebo. The sessions were four weeks apart.