Politico February 14, 2024
Erin Schumaker, Daniel Payne, Carmen Paun and Ruth Reader

The Food and Drug Administration has accepted Lykos Therapeutics’ new drug application for psychedelic-assisted therapy, teeing up 2024 as a potentially transformative year for psychedelic medicine.

The FDA granted the application priority review, meaning the agency will review it over six months instead of the standard 10-month timeline. The agency set a target date of Aug. 11 to decide whether to approve the application.

Lykos’ application is for talk therapy combined with MDMA, commonly called ecstasy, as a treatment for post-traumatic stress disorder.

The company, formerly known as the MAPS Public Benefit Corp., rebranded last month. MAPS’ research arm has studied MDMA as a PTSD treatment for more than 30 years. Its application marks the first time the FDA has...

Today's Sponsors

Venturous
Got healthcare questions? Just ask Transcarent

Today's Sponsor

Venturous

 
Topics: Biotechnology, FDA, Govt Agencies, Mental Health, Pharma, Pharma / Biotech, Provider
A Tale of Two Mental Health Crises
For teens' mental health, strong friendships matter more than social media use, study finds
VA Layoffs Could Disrupt Behavioral Health Services
Navigating Complex Payer Processes in Behavioral Health
Inside Caron Treatment Centers’ Addiction Research: Exploring GLP-1s and Genetic Markers

Share This Article