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.

Tosymra鼻喷雾剂10 mg是根据505（b）2途径批准的专有急性偏头痛治疗，基于与Imitrex（舒马曲坦）注射液的生物等效性4 mg葛兰素史克最近通知FDA，它将停止使用Imitrex鼻喷雾剂5 mg和20 mg产品2024年1月-新泽西州查塔姆市9月。

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.

062023（GLOBE NEWSWIRE）-Tonix Pharmaceuticals Holding Corp.（纳斯达克股票代码：TNXP）（Tonix或该公司），一家拥有销售产品和开发候选人管道的生物制药公司，今天宣布，承诺在2024年1月之后葛兰素史克（GSK）计划停用Imitrex（舒马曲坦）鼻腔喷雾剂5 mg和20 mg产品后，满足Tosymra®（舒马曲坦）鼻腔喷雾剂10 mg潜在增加的需求。

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.

2023年8月8日，葛兰素史克通知美国食品和药物管理局（FDA）计划在2024年1月31日后停用Imitrex鼻腔喷雾剂5 mg和20 mg。该通知发布在FDA药物短缺网站上.1 Tonix正在准备增加对Tosymra（舒马曲坦鼻喷雾剂）10 mg的需求，以帮助避免偏头痛患者可能出现药物短缺。

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.

Tosymra鼻喷雾剂基于与Imitrex注射液4 mg的生物等效性获得批准。药物短缺对美国医疗保健系统提出了持续的挑战，最近几个月达到接近创纪录的水平2，导致治疗延误和配给。Tonix准备着手缓解舒马曲坦的潜在短缺，舒马曲坦是一种广泛使用的急性偏头痛治疗选择。

“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. .

Tonix总裁兼首席执行官Seth Lederman博士说：“为了回应FDA的宣传，我们已经确认我们承诺满足偏头痛患者对舒马曲坦鼻腔喷雾剂潜在增长的需求。”。