- 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 compresses the final review timeline from roughly 10–12 months down to 1–2 months. This streamlined pathway will be available to a limited number of companies aligned with public health priorities such as addressing the health crisis in the U.S., increasing domestic drug manufacturing, and the development of more innovative treatments.
NRX-100 appears to fit that profile. Developed as a preservative-free formulation of ketamine, the drug targets severe psychiatric conditions that have received renewed national attention. Suicide and PTSD have been highlighted by federal officials, including the U.S. president and Cabinet members, as areas requiring urgent intervention.
NRx emphasized that it has already submitted the Chemistry, Manufacturing, and Controls (“CMC”) portion of the application and received an FDA information request, which it has addressed. The company also submitted proposed labeling and reports stability and sterility data that suggest a three-year shelf life at room temperature, an important logistical benefit for hospital and clinical settings.
Jonathan C. Javitt, MD, MPH, Chairman and CEO of NRx, said the CNPV aligns with the company’s strategy. “As previously determined by FDA, our products are innovative treatments that address the current health crisis of suicidal depression and PTSD, and address an unmet medical need,” Javitt explained. “The FDA’s announcement has now validated our company’s focus on manufacturing and CMC by identifying CMC as a pre-requisite to the CNPV program. The timelines announced for the CNPV program are consistent with NRx’s previous guidance of FDA decisions (PDUFA date) by year-end 2025.”
In parallel, the company has filed an Abbreviated New Drug Application (“ANDA”) for NRX-100 with a request for priority review. The two pathways, CNPV and ANDA, are expected to complement one another, according to the company. Should the CNPV be granted, the drug could enter a Commissioner-led review program with integrated oversight from key FDA offices.
The formulation also has manufacturing and market advantages. NRX-100 is produced domestically in West Columbia, South Carolina, addressing concerns over reliance on international ketamine supply chains. The company has added anti-diversion measures to limit misuse, an important step in addressing the growing scrutiny around ketamine’s off-label use.
To further solidify its market position, NRx is pursuing a citizen petition to withdraw preservative-containing versions of ketamine, citing toxicity from benzethonium chloride. If successful, this could clear regulatory space for NRX-100 while reinforcing its safety claims. The company has also filed a patent on its preservative-free manufacturing process.
Ketamine is already approved for anesthesia and has seen expanded use in off-label psychiatric treatment. The current generic ketamine market, valued at around $750 million, is projected to grow to $3–5 billion by 2033. A preservative-free product with clear regulatory backing could appeal to both hospital buyers and psychiatric treatment centers seeking safer and more standardized formulations.
The FDA previously granted Fast Track designation to NRX-101, a combination therapy of NRX-100 and another compound, further indicating regulatory interest in the company’s approach to treating high-risk psychiatric conditions.
For more information, visit the company’s website at www.NRxPharma.com.
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://ibn.fm/NRXP
