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Tonix Pharmaceuticals Announces Commitment to Supply Tosymra® (sumatriptan Nasal Spray) 10 mg for Treatment of Acute Migraine to Meet Potential Increased Demand Following GSK’s Planned Discontinuation of Imitrex® (sumatriptan) Nasal Spray After Januar...
Tonix Pharmaceuticals Announces Commitment to Supply Tosymra® (sumatriptan Nasal Spray) 10 mg for Treatment of Acute Migraine to Meet Potential Increased
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Tonix Pharmaceuticals Announces Commitment to Supply Tosymra® (sumatriptan Nasal Spray) 10 mg for Treatment of Acute Migraine to Meet Potential Increased Demand Following GSK’s Planned Discontinuation of Imitrex® (sumatriptan) Nasal Spray After January 2024 \n Tosymra Nasal Spray 10 mg is a Proprietary Acute Migraine Treatment Approved Under the 505(b)2 Pathway Based on Bioequivalence to Imitrex (sumatriptan) Injection 4 mg GlaxoSmithKline Recently Notified FDA that it will Discontinue Imitrex Nasal Spray 5 mg and 20 mg Products after January 2024 CHATHAM, N.J., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it is committed to meeting potential increased demand for Tosymra® (sumatriptan) nasal spray 10 mg after GlaxoSmithKline’s (GSK) planned discontinuation of Imitrex (sumatriptan) nasal spray 5 mg and 20 mg products after January, 2024. On August 8, 2023, GSK informed the U.S. Food and Drug Administration (FDA) of its plan to discontinue Imitrex nasal spray 5 mg and 20 mg doses after January 31, 2024. The notification is posted on the FDA Drug Shortages website.1 Tonix is preparing for potential increased demand for Tosymra (sumatriptan nasal spray) 10 mg to help avoid possible drug shortages for patients who suffer from migraines. Tosymra nasal spray is approved on the basis of bioequivalence to Imitrex injection 4 mg. Drug shortages have presented an ongoing challenge for the U.S. healthcare system, reaching near-record levels2 in recent months, causing treatment delays and rationing. Tonix is ready to step in to alleviate potential shortages in sumatriptan, a widely used treatment option for acute migraine. “In response to FDA outreach, we have confirmed our commitment to meet potential increased demand for sumatriptan nasal spray from patients who suffer from migraines,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “While Tosymra nasal spray and Imitrex nasal spray are not substitutable at the pharmacy, we plan to alert providers to the possibility of prescribing Tosymra for patients who may benefit from a nasal spray formulation of sumatriptan.” The American Headache Society Consensus Statement on migraine treatments re...