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Jump to Key Points This digest highlights FDA activity in September related to therapeutics and devices for psychiatric illness. For information on approvals in other specialties during 2026, see our FDA Drug Approvals page.
FDA Weighs Safety Framework for Psychedelics
Clinicians, researchers, and advocates urged the FDA at a 4-hour hearing to issue definitive access and safety recommendations for psychedelic drugs. Key areas of discussion included gaps in provider training, questions around patient monitoring, risk management, and long-term safety tracking. Earlier this month, FDA officials published a paper that proposed a framework for developing new psychedelic drugs for conditions such as depression and posttraumatic stress disorder.
Lysergide (LSD) Drug Scores Second Breakthrough Therapy Status
The FDA granted DT120 (LSD, Definium Therapeutics) a second Breakthrough Therapy designation, this time for major depressive disorder (MDD). The designation rests on the phase 3 Emerge study, in which a single 100-µg dose produced an 8.1-point placebo-adjusted improvement in depression scores at 6 weeks, with effects lasting through week 12. The designation was followed days later by company reports that the drug reduced symptoms of generalized anxiety disorder (GAD) in a second late-stage trial. Definium reports it plans to pursue a broad FDA label covering both GAD and MDD.
Device Earns Breakthrough Status for Stimulant Use Disorder
NeuroElectric Therapy (NET) Recovery’s transcutaneous alternating current stimulator, the NET Device, received FDA Breakthrough Device Designation to reduce psychostimulant use in adults with stimulant use disorder, the company announced. No drug or device is yet FDA-approved for cocaine or methamphetamine use disorder, notably because more than half of recent US overdose deaths involved stimulants. The device is FDA-cleared for the management of opioid withdrawal. The company is currently planning a trial to support marketing authorization.
- FDA hearing urged clearer psychedelic access/safety guidance; gaps in training, monitoring, risk mgmt.
- FDA paper proposed framework for psychedelic drug development in depression, PTSD.
- LSD drug DT120 gained 2nd Breakthrough Therapy status for MDD.
- Phase 3: single 100-µg dose improved depression scores by 8.1 points vs placebo at 6 weeks.
- NET Device earned Breakthrough Device status for stimulant use disorder; no approved cocaine/meth treatments.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
