Lykos Therapeutics, a leading biotech company in the psychedelic field, has announced that it will be the first to have an FDA advisory meeting for a psychedelic treatment. The meeting with the Psychopharmacologic Drugs Advisory Committee is scheduled to take place on June 4. Lykos is seeking FDA approval to use MDMA (commonly known as ecstasy) to treat patients suffering from post-traumatic stress disorder (PTSD).

This groundbreaking meeting marks the first time in 25 years that the FDA will formally debate a new treatment for PTSD. Lykos, formerly known as MAPS PBC, has been at the forefront of the psychedelic space and was the first company in the field to apply for FDA approval, with their application successfully accepted for review.

CEO Amy Emerson expressed her excitement about this milestone, highlighting the significant need for effective treatments for patients with PTSD. The data that will be reviewed during the FDA advisory committee meeting will primarily come from Lykos' impressive portfolio, including six Phase 2 studies, two pivotal Phase 3 studies, and a long-term follow-up study.

Both Phase 3 trials conducted by Lykos met their primary endpoint by demonstrating an improvement in PTSD symptoms compared to patients who received a placebo and psychological intervention. This success, along with the rapid growth and investment in the psychedelic field, led to Lykos raising a substantial $100 million in private financing earlier this year.

The FDA is expected to decide on the approval of Lykos' MDMA-assisted therapy by mid-August. If approved, Lykos will still have to wait for the Drug Enforcement Agency (DEA) to reschedule MDMA to a lower category. Currently, MDMA is classified as a Schedule 1 substance, alongside heroin, marijuana, and Quaalude. However, there have been recent discussions and movements towards rescheduling substances like marijuana, with the potential for medicinal benefits.

Once MDMA is rescheduled, efforts will shift to individual states for any required legislation to allow its use. Some states already have policies in place that align with the DEA's lead, while others will need to pass new legislation to greenlight the usage of MDMA in PTSD treatment.

The FDA advisory meeting for Lykos Therapeutics' MDMA-assisted therapy represents a significant step forward in the evolving field of psychedelic medicine. If successful, this could provide hope for countless individuals suffering from PTSD, opening up new avenues for treatment and relief.