CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a biopharmaceutical company, is set to transition into a fully integrated pharmaceutical company by April 1, 2024.
The company announced its readiness to take over the distribution, selling, and marketing of two migraine treatments: Zembrace® SymTouch® and Tosymra®. Both medications are designed for the acute treatment of migraines in adults, with Zembrace® SymTouch® being a sumatriptan injection and Tosymra® a sumatriptan nasal spray.
Tonix's acquisition of these products on June 30, 2023, marked the beginning of establishing the necessary commercial infrastructure. The company's CEO, Seth Lederman, M.D., expressed that assuming commercial activities is a significant step in Tonix's growth, as it prepares for the potential 2025 launch of its fibromyalgia management drug, Tonmya™, pending FDA approval.
Zembrace® SymTouch® is currently the only actively promoted sumatriptan autoinjector in the U.S., distinct for its low dosage and rapid onset of pain relief, with patent protection extending to 2036. Tosymra® utilizes Intravail® technology and is equivalent to 4 mg subcutaneous sumatriptan, offering pain relief in as little as 10 minutes for some patients and is patented through 2031.
Tonmya™, a bedtime medication for fibromyalgia management, has shown promising results in two Phase 3 clinical trials, with the second trial, RESILIENT, yielding highly significant outcomes. The company aims to submit a New Drug Application to the FDA in the latter half of 2024.
Migraine affects nearly 40 million people in the U.S. and is a leading cause of disability worldwide. Tonix's commitment to addressing this condition is part of its broader focus on central nervous system disorders and the development of non-opioid, non-addictive treatments.
This move by Tonix Pharmaceuticals is based on a press release statement and represents an important milestone for the company as it expands its commercial capabilities and prepares for future product launches.
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