NRx Pharmaceuticals Seeks FDA Priority Voucher for Accelerated Review of NRX-100 Ketamine Formulation
TL;DR
NRx Pharmaceuticals seeks FDA's CNPV for NRX-100, aiming to reduce review time to 1-2 months, potentially leading the $5 billion ketamine market by 2033.
NRx Pharmaceuticals has submitted the CMC portion for NRX-100, a preservative-free ketamine, under FDA's CNPV program for accelerated review by late 2025.
NRx Pharmaceuticals' NRX-100 could revolutionize treatment for suicidal depression and PTSD, addressing urgent U.S. health needs with a faster, preservative-free ketamine solution.
NRx Pharmaceuticals is pioneering a preservative-free ketamine treatment, NRX-100, with potential to transform mental health care and chronic pain management.
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NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) has taken a significant step towards accelerating the availability of its NRX-100 ketamine formulation by applying for the FDA Commissioner’s National Priority Voucher (CNPV) program. This move could potentially reduce the review time for NRX-100 from the standard 10–12 months to just 1–2 months, marking a pivotal moment in the treatment of conditions such as suicidal depression and PTSD.
The company’s application is based on the belief that NRX-100 meets all the criteria set forth by FDA Commissioner Marty Makary for treatments addressing urgent U.S. health needs. With the chemistry, manufacturing, and controls (CMC) portion of its application already submitted and feedback received from the FDA, NRx is on a clear path towards the potential accelerated review of its full New Drug Application (NDA) by late 2025.
In addition to seeking the priority voucher, NRx Pharmaceuticals is also advancing a citizen petition to withdraw preservative-containing ketamine products from the market. The company has filed a patent for its preservative-free manufacturing process, aiming to secure a significant share in the ketamine market, which is projected to reach up to $5 billion annually by 2033.
The implications of NRx Pharmaceuticals’ efforts are profound, offering hope for faster access to innovative treatments for some of the most pressing mental health challenges facing the U.S. today. The potential acceleration in the review process for NRX-100 could set a precedent for how treatments for urgent health needs are prioritized and brought to market in the future.
Curated from InvestorBrandNetwork (IBN)
