Tonix Pharma Announces U.S. Patent for Subcutaneous Zembrace® SymTouch® for Migraines

Tonix Pharmaceuticals Holding Corp. has recently announced the issuance of U.S. Patent No. 12,097,183 by the United States Patent and Trademark Office. The patent, titled "Pharmaceutical Composition for Treating Migraine," pertains to the use of a pre-filled autoinjector containing Zembrace® SymTouch® (sumatriptan succinate injection) for treating migraines. This patent is expected to extend market exclusivity for Zembrace® SymTouch® into 2036, excluding any potential patent term extensions.

Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, expressed enthusiasm about this new patent, emphasizing that it strengthens their exclusive rights to market and sell Zembrace® SymTouch®. The drug is an FDA-approved, non-oral treatment option for adult patients suffering from acute migraine episodes.

In parallel with this patent announcement, Tonix Pharmaceuticals has initiated a new educational campaign titled "Does Your Migraine Pill Work Every Time?" This campaign aims to inform patients and healthcare providers about the benefits of non-oral migraine treatments, such as nasal sprays and injectable medications. These types of treatments do not depend on the digestive system for absorption, potentially offering faster relief from migraine symptoms, sometimes in as little as ten minutes.

Managing migraines effectively often requires patients to advocate for themselves. Understanding the limitations of oral medications, which can be impacted by conditions like gastroparesis, is crucial. Gastroparesis, a condition that slows or disrupts the digestive process, can hinder the absorption of oral migraine medications, leading to delayed or incomplete relief. Tonix aims to empower patients with this knowledge, thus improving their approach to migraine treatment and enhancing their overall quality of life.

To further support this educational initiative, Tonix will be launching a new website, www.gpmigraine.com. This resource will provide patients with detailed information on the relationship between gastroparesis and migraines, helping them understand why their oral medications might not be effective.

Dr. Lederman emphasized the company's commitment to educating both patients and healthcare providers about gastroparesis and the advantages of non-oral migraine treatments. He hopes that this education will inspire patients to consider optimizing their migraine management strategies with alternative treatment methods.

Migraines affect nearly 40 million individuals in the United States and are recognized as the second leading cause of disability globally. Migraine attacks are characterized by intense, pulsating headaches that can last from four to 72 hours, often accompanied by nausea, vomiting, and heightened sensitivity to light and sound.

Tonix Pharmaceuticals is a fully integrated biopharmaceutical company focused on developing treatments for pain management and public health challenges. Their development pipeline includes several candidates targeting central nervous system disorders, rare diseases, and infectious diseases. Notably, they are preparing to submit a New Drug Application to the FDA for TNX-102 SL, a candidate for fibromyalgia management. Additionally, Tonix is developing TNX-1300 for cocaine intoxication and TNX-1500, a monoclonal antibody for preventing organ transplant rejection and treating autoimmune diseases.

Tonix also markets Zembrace® SymTouch® and Tosymra® (sumatriptan nasal spray) for the treatment of acute migraines in adults. Recently, they were awarded a contract by the U.S. Department of Defense to develop TNX-4200, a small molecule antiviral agent aimed at improving military medical readiness in biological threat environments. The company operates a state-of-the-art infectious disease research facility in Frederick, MD, which plays a crucial role in advancing their development efforts.

In summary, Tonix Pharmaceuticals is making significant strides in migraine treatment through patent protection, educational campaigns, and a diverse development pipeline aimed at addressing various medical needs.