Tonix Pharma Secures U.S. Patent for Tosymra® Intranasal Migraine Treatment

Tonix Pharmaceuticals Holding Corp., a fully-integrated biopharmaceutical company, recently announced the issuance of U.S. Patent No. 12,090,139 by the United States Patent and Trademark Office. The new patent, titled "Formulations Comprising Triptan Compounds," is crucial for the company's product Tosymra® (sumatriptan nasal spray) 10mg. This patent, which is expected to expire in 2030, details a pharmaceutical composition and a method for treating migraines through intranasal administration, as well as an intranasal delivery system.

Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, stated, "We believe this patent further solidifies Tosymra® in the market as a differentiated drug with a unique administration method. We are thrilled to have these additional issued patent claims, which add to the intellectual property protection existing for Tosymra®."

Migraines are a significant public health concern, affecting nearly 40 million people in the United States alone. Recognized as the second leading cause of disability worldwide, migraines involve debilitating attacks that can last from four to 72 hours. Symptoms typically include severe pulsating headaches, nausea, vomiting, and sensitivity to light (photophobia) and sound (phonophobia).

Tonix Pharmaceuticals Holding Corp. is dedicated to developing innovative therapies for pain management and addressing public health challenges. The company's development portfolio is primarily focused on central nervous system (CNS) disorders. A key product in their pipeline is TNX-102 SL, aimed at managing fibromyalgia. The FDA has already granted Fast Track designation to TNX-102 SL, which is also being explored as a treatment for acute stress reaction.

Another significant product in Tonix's CNS portfolio is TNX-1300, a biologic currently in Phase 2 development for treating cocaine intoxication. TNX-1300 has received Breakthrough Therapy designation, highlighting its potential impact. In their immunology portfolio, Tonix is developing TNX-1500, a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154). This product aims to prevent organ transplant rejection and treat autoimmune diseases.

Tonix is also working on treatments for rare diseases, such as TNX-2900 for Prader-Willi syndrome, and infectious diseases, including a vaccine for mpox, TNX-801. Recently, the U.S. Department of Defense (DoD) awarded Tonix a contract worth up to $34 million over five years to develop TNX-4200. This small molecule antiviral agent targets CD45 and aims to improve the medical readiness of military personnel in biological threat environments.

The company owns and operates a state-of-the-art infectious disease research facility in Frederick, Maryland, which plays a crucial role in advancing their development projects. Tonix's commercial subsidiary, Tonix Medicines, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the acute treatment of migraines in adults.

It is important to note that all of Tonix's product development candidates, including those mentioned, are investigational new drugs or biologics and have not yet received approval for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines, while other trademarks belong to their respective owners.

Tosymra® is a prescription medication indicated for the acute treatment of migraine headaches with or without aura in adults. However, it is not suitable for treating other types of headaches such as hemiplegic or basilar migraines, nor is it used for preventing migraines. The safety and effectiveness of Tosymra® in individuals under 18 years of age have not been established.

Tosymra® can cause serious side effects, including heart attack and other heart problems, which may be fatal. People with risk factors for heart disease should undergo a heart exam before using Tosymra®. Users should stop taking Tosymra® and seek emergency medical help if they experience symptoms of a heart attack. The medication should not be used by individuals with certain medical conditions or those taking specific medications, as outlined by healthcare providers. Common side effects of Tosymra® include tingling, dizziness, feelings of warmth or heaviness, and application site reactions.

For further information, patients are advised to consult their healthcare providers and review the Patient Information and Instructions for Use. Additionally, negative side effects of prescription drugs should be reported to the FDA.