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Tonix Pharmaceuticals Announces FDA Orphan-Drug Designation for TNX-2900 for the Treatment of Prader-Willi Syndrome
CHATHAM, N.J., March 03, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"CHATHAM, N.J., March 03, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan-Drug Designation for TNX-2900* (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. “Orphan-Drug Designation by the FDA is an important milestone and further validates our efforts to investigate the utility of TNX-2900 for Prader-Willi syndrome,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “It underscores the urgent, unmet medical need for patients diagnosed with this disease, and will benefit us as we continue to advance our program.” As recently announced, Tonix entered into a sponsored research agreement with Inserm Transfert, the private subsidiary of Inserm, on behalf of Inserm (the French National Institute of Health and Medical Research) and Aix-Marseille Université to study oxytocin in the genetically engineered mouse model of Prader-Willi syndrome, a rare genetic disorder that causes distinct, but related pathological eating disorders in adults and newborns. In adults, Prader-Willi causes hyperphagia, or pathological over-eating, which leads to obesity and other complications associated with significant mortality. In newborns, Prader-Willi causes a deficiency in suckling, which has been shown to be normalized by oxytocin treatment. The FDA’s Office of Orphan Drug Products grants orphan status to the active moiety of drugs and biologics that demonstrate promise for the treatment of diseases or conditions affecting fewer than 200,000 people in the United States. Orphan drug designation provides Tonix Pharmaceuticals with certain development incentives, including tax credits for qualified clinical testing, exemptions from certain FDA application fees, and potential market exclusivity for seven years, if approved. *TNX-2900 is an investigational new drug and has not been approved for any indication. About Prader-Willi Syndrome Prader-Willi syndrome is recognized as the most common genetic cause of life-threatening childhood obesity1 and affects males and females with equal frequency and all races and ethnicities. The hallmarks of Prader-Willi syndrome are lack of suckling in infants and, in children and adults, severe h...