The Uncertain Path Forward for Psychedelic Medicine

August 15, 2024

cluster of mushrooms

(Wired) – After the FDA rejected its proposed MDMA treatment, Lykos Therapeutics is laying off 75 percent of its staff and its founder has left the company.

The FDA decision underscores the difficulty of getting regulatory approval for a psychedelic-based treatment. Not only was the FDA evaluating an illegal psychedelic for the first time, it was also reviewing the drug in combination with a type of psychotherapy developed by Lykos. Advisers struggled with disentangling the drug’s effects from the psychotherapy—a realm the FDA doesn’t regulate. (Read More)