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This roundup highlights a number of actions taken in May by the FDA related to therapeutics for psychiatric illness. For information on approvals in other specialties during the first quarter of 2026, see the Medscape Medical News FDA Drug Approvals page.
FDA Clears Combined Drug-Device Depression Trial
On May 7, the FDA approved the launch of a phase 2/3 clinical trial to study the efficacy of NRX-101, a fixed-dose combination of D-cycloserine-lurasidone, when added to transcranial magnetic stimulation for treatment-resistant depression and suicidality. The randomized, placebo-controlled MIND1 study will include approximately 240 participants at multiple sites, manufacturer NRx Pharmaceuticals said in a statement. Additional participants will be recruited from military treatment facilities, the company added. NRX-101 is also under study for bipolar depression with suicidality, for which it received FDA Breakthrough Therapy Designation in 2018.
Posttraumatic Stress Disorder (PTSD) Neuromodulation Device Receives Clearance
The FDA awarded de novo approval on May 26 to a wearable neuromodulation device for the treatment of PTSD, manufacturer Neurovalens announced in a statement. The device, Modius Spero, delivers low-level electrical stimulation to specific brain regions to help address PTSD symptoms and is the first neuromodulation device approved for PTSD symptoms under the de novo pathway, the company reported. It will be available to veterans through the US Department of Veterans Affairs beginning this summer.
FDA Renews Psychopharmacologic Advisory Committee
On May 29, the FDA announced it is renewing the Psychopharmacologic Drugs Advisory Committee by the Commissioner of Food and Drugs for an additional 2 years. The committee reviews and evaluates the safety and efficacy of existing and investigational psychiatric medications. The renewal, announced in the Federal Register, extends the charter of the nine-member committee to June 4, 2028.
