Pharma Focus Europe

Tonix Pharmaceuticals Successfully Acquires Two FDA-Approved Migraine Products Already in the Market

Monday, July 03, 2023

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) and its subsidiary, Tonix Medicines, Inc., have recently completed the acquisition of two FDA-approved products from Upsher-Smith Laboratories, LLC. The acquired products are Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine in adults, with or without aura. These products generated approximately $23 million in product sales in 2022.

Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, expressed the significance of this acquisition for the company's transformation into a fully integrated biopharmaceutical company, particularly in the field of central nervous system disorders. The acquisition not only provides potential growth opportunities for the two acquired products but also strengthens Tonix's commercial capabilities in preparation for the potential launch of TNX-102 SL, a product candidate for fibromyalgia treatment, and aligns with TNX-1900, a product candidate for preventing chronic migraine headaches.

James Hunter, EVP of Commercial Operations at Tonix Pharmaceuticals and President of Tonix Medicines, highlighted the burden of migraine headaches and breakthrough migraines and believes that Zembrace SymTouch and Tosymra are well-suited to meet the unmet needs of patients who rely on traditional or emerging oral acute migraine medications. These products offer rapid-onset treatment, with Zembrace SymTouch providing migraine pain relief in as little as 10 minutes and Tosymra delivering relief with a single spray for some patients.

Zembrace SymTouch is the only actively promoted brand of sumatriptan autoinjector in the United States, while Tosymra utilizes Intravail permeation enhancer technology and is pharmacokinetically equivalent to 4 mg subcutaneous sumatriptan. Zembrace SymTouch is protected by a patent until 2036, and Tosymra has patent protection until 2031.

Migraine affects nearly 40 million people in the United States and is recognized as the second leading cause of disability globally. It is characterized by severe headaches lasting from four to 72 hours, often accompanied by symptoms such as nausea, vomiting, phonophobia, and photophobia.

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