- The new FDA voucher program aims to speed approval of drugs aligned with national health priorities.
- NRX-100, a preservative-free ketamine, is also under an Abbreviated New Drug Application (“ANDA”) with a priority review request.
- NRx has submitted full CMC data and draft labeling for NRX-100, meeting key Commissioner’s National Priority Voucher pre-qualification criteria.
- The company’s U.S.-based manufacturing aims to reduce foreign supply chain dependence and address diversion concerns.
- A patent on the preservative-free process and a citizen petition to withdraw preserved ketamine could bolster NRx’s market position.
NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company developing innovative treatments for suicidal depression and PTSD, is accelerating its push toward regulatory approval of NRX-100, a preservative-free intravenous ketamine formulation. The company has filed an application under the newly created FDA Commissioner’s National Priority Voucher (“CNPV”) program, which promises significantly shortened review timelines for drugs that meet urgent U.S. health priorities (https://ibn.fm/VeYud).
The new CNPV program, announced by FDA Commissioner Marty Makary on June 17, is intended to bring promising treatments to market more quickly. Makary had previously identified psychedelic drugs for treatment of suicidal depression and PTSD as a national priority. For eligible drugs, the program…
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://ibn.fm/NRXP
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