NRx Pharmaceuticals Intends To Submit New Drug Application For NRX-100 By June Following Successful Type-C FDA Guidance Meeting
Benzinga Newsdesk 7 months ago
NewsFDA
NRXP has received confirmatory minutes from an in-person Type C guidance meeting at the headquarters of the US Food and Drug Administration. The meeting was attended by leaders of the FDA Division of Psychiatry Products,
NRXP has received confirmatory minutes from an in-person Type C guidance meeting at the headquarters of the US Food and Drug Administration. The meeting was attended by leaders of the FDA Division of Psychiatry Products, the FDA Office of Neuroscience, and the FDA Center for Drug Evaluation and Research.
The minutes support FDA's willingness to review NRx's application for New Drug Approval of NRX-100 (preservative-free ketamine) based on Substantial Evidence of Effectiveness derived from existing adequate and well controlled trials. No additional clinical trials were requested. NRx agreed with FDA to submit existing patient-level data for review.