In a watershed U.S. regulatory milestone, the MAPS Public Benefit Corporation announced Tuesday that it has submitted a New Drug Application to the FDA for an investigational MDMA-assisted therapy for individuals with post-traumatic stress disorder.
Tag Archive for: MDMA
With the potential FDA approval of an MDMA-based therapy for PTSD on the horizon, biopharma stakeholders are eyeing psychedelics with fresh anticipation.
The Multidisciplinary Association for Psychedelic Studies (MAPS) plans to file for regulatory approval for the party drug MDMA as a treatment for post-traumatic stress disorder in the United States later this year, in a potential boost to the nascent psychedelic therapeutics industry.
Developers of psychedelics-based therapies say the industry is poised to explode, with several reporting strong clinical trial results and the FDA granting breakthrough status for two hallucinogenic drugs.
BioSpace sat down with Katy Powell, a psychiatric mental health nurse practitioner in Portland, Oregon, to discuss the relative risks and benefits associated with psychedelic-assisted therapy.
