NRx: More Alignment with FDA on Initiation of Registrational Trials for Chronic Pain Therapy

 

• "Study May Proceed" letter received from FDA
• IND preclinical requirements are consistent with studies already in progress to support treatment of Bipolar Depression
• Potential to initiate registrational studies in 2024, pending receipt of data from already-completed DOD-funded trial of D-cycloserine

https://www.biospace.com/article/releases/nrx-pharmaceuticals-announces-further-alignment-with-fda-on-initiation-of-registrational-trials-for-nrx-101-in-the-treatment-of-chronic-pain/