30 Oct What’s Next for Psychedelic Medicines?

By Marissa Plescia, MedCity News

After the Food and Drug Administration’s recent decision to delay the approval of MDMA-assisted therapy for post-traumatic stress disorder, the path forward has become less straightforward for the field of psychedelic medicines. But this isn’t the end of the road, according to a panel of experts last week at the HLTH 2024 conference in Las Vegas.

The new drug application was submitted by Lykos Therapeutics and would have been the first new treatment option for PTSD in over two decades, according to the company. The drug would have been provided with talk therapy. The FDA requested in August that the company conduct an additional Phase 3 trial to evaluate the safety of the treatment. The agency’s choice came after an independent advisory committee cited several concerns, including badly designed studies and allegations of sexual misconduct during a mid-stage clinical trial, according to NBC News. Read more…