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News
The FDA had a busy September in psychiatric therapeutics. An LSD-based drug earned Breakthrough Therapy status for major depressive disorder after a phase 3 trial showed lasting antidepressant effects, and a non-invasive brain stimulation device scored Breakthrough Device Designation for stimulant use disorder — a condition with zero FDA-approved treatments. Meanwhile, the FDA is actively working to shape a safety and access framework for psychedelics.
September was a landmark month for psychiatric innovation at the FDA. Definium Therapeutics' DT120 — an LSD-based oral tablet — received its second Breakthrough Therapy designation, this time for major depressive disorder (MDD), following strong phase 3 results. The company also reported positive late-stage data for generalized anxiety disorder (GAD) and is now pursuing a broad FDA label covering both conditions.
On the device front, the NET Device — a transcutaneous alternating current stimulator — earned FDA Breakthrough Device Designation for stimulant use disorder. This is significant because no drug or device is currently FDA-approved for cocaine or methamphetamine addiction, even as stimulants are implicated in more than half of recent US overdose deaths.
Rounding out the month, the FDA held a 4-hour public hearing where clinicians, researchers, and advocates pushed for clear safety and access standards for psychedelic drugs, covering provider training, patient monitoring, and long-term safety tracking.
By the Numbers
Why it matters: These developments signal a rapidly evolving regulatory landscape for psychiatric treatments — from psychedelics to neurostimulation — targeting conditions that have long lacked effective therapies.
