NRx Pharmaceuticals Gains FDA Clearance for 240-Participant NRX-101 TMS Phase 2/3 Trial
NRXP•FDA cleared NRx to begin a randomized, double-blind phase 2/3 trial of NRX-101 combined with robotic-enabled transcranial magnetic stimulation in depression with suicidality. The study will enroll 240 participants at a US academic hospital, three HOPE clinics and two military facilities, backed by non-dilutive funding targeting 400 patients.
1. FDA Clearance and Trial Design
NRx Pharmaceuticals has received FDA clearance to initiate a randomized, double-blind, placebo-controlled phase 2/3 trial evaluating NRX-101 (D-cycloserine/lurasidone) combined with robotic-enabled transcranial magnetic stimulation in adults with treatment-resistant major depressive disorder and suicidality. The three-arm study will compare NRX-101 plus active TMS, NRX-101 plus sham TMS and placebo plus TMS across 240 enrolled participants.
2. Trial Sites and Enrollment
The trial is slated to enroll participants at a leading US academic hospital and three HOPE Therapeutics clinics, with additional cohorts at two US military treatment facilities pending IRB approvals. The study is identified as MIND1 and will be overseen by Professor Josh Brown, who led earlier DARPA-funded Phase 1 and 2 studies.
3. Funding and Strategic Implications
NRx Defense Systems, a subsidiary of NRx Pharmaceuticals, aims to secure non-dilutive funding to support up to 400 patient enrollments. Positive outcomes could fast-track adoption of a short-term, noninvasive treatment to enhance force readiness among military and first responders.
