NRx Pharmaceuticals, Inc. (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has taken a significant step towards ensuring the safety of ketamine products by filing a Citizen Petition with the U.S. Food and Drug Administration (FDA). The petition seeks the removal of Benzethonium Chloride (BZT), a preservative found in ketamine products, due to its potential toxicity and lack of recognition as safe for certain uses.
The company's action is rooted in concerns over BZT's safety profile. According to NRx Pharmaceuticals, BZT is not Generally Recognized as Safe (GRAS) for parenteral use or Generally Recognized as Safe and Effective (GRASE) for topical use. Studies have shown that BZT can be toxic to epithelial cells and nerves, raising significant health concerns for patients using ketamine products containing this preservative. Ketamine is currently used to treat conditions such as suicidal depression and PTSD, making the safety of its formulation a critical issue for vulnerable populations.
In support of its petition, NRx Pharmaceuticals highlights its development of a preservative-free ketamine formulation, which boasts three-year room temperature stability and sterility. This formulation is backed by a newly filed patent, underscoring the company's commitment to providing safer alternatives. Furthermore, NRx is pursuing a labeled indication for suicidal depression under the FDA Commissioner’s National Priority Voucher Program, emphasizing the importance of addressing mental health crises with safe and effective treatments.
The implications of this petition are far-reaching. If successful, it could lead to the removal of BZT from all ketamine products in the U.S., aligning with broader federal efforts to eliminate toxic additives from the drug supply. This move not only has the potential to improve patient safety but also sets a precedent for the scrutiny of preservatives and additives in pharmaceutical formulations. For more information on NRx Pharmaceuticals' initiatives, visit https://ibn.fm/h6yS7.
