WILMINGTON, DE — NRx Pharmaceuticals (Nasdaq: NRXP) received U.S. Food and Drug Administration clearance to begin a late-stage clinical trial evaluating whether its investigational NRX-101 therapy can improve outcomes for patients with treatment-resistant depression undergoing transcranial magnetic stimulation, potentially expanding noninvasive treatment options for military personnel and first responders.
The placebo-controlled Phase 2/3 trial, known as MIND1, will study NRX-101 — a fixed-dose combination of D-cycloserine and lurasidone — in adults with major depressive disorder and suicidality who are treated with either robotic-assisted transcranial magnetic stimulation, or TMS, or sham TMS, the company announced.
NRx said the randomized portion of the study is expected to enroll 240 participants at a U.S. academic teaching hospital and three planned clinical sites operated by HOPE Therapeutics. Additional participants are expected to be recruited through two U.S. military treatment facilities pending institutional review board approvals…