Tonix Pharmaceuticals announced an agreement with a leading group purchasing organization (GPO) that provides coverage to approximately 35 million U.S. commercial lives, representing approximately 20% of the roughly 177 million commercial lives in the U.S., for TONMYA (cyclobenzaprine HCl sublingual tablets), effective May 1, 2026. TONMYA is the first FDA-approved treatment for fibromyalgia in adults in more than 15 years, commercially launched in November 2025.
According to Dr. Seth Lederman, President and Chief Executive Officer of Tonix Pharmaceuticals, “This agreement is an important milestone in expanding patient access to TONMYA.” The company continues to pursue additional coverage across commercial and government channels. Tonix also continues discussions with Medicare and Medicaid. To date, TONMYA is covered under Medicaid in 38 states for approximately 55 million lives representing 73% of the roughly 75 million Medicaid lives.
Fibromyalgia is a chronic pain disorder afflicting more than 10 million adults in the U.S., approximately 90% of whom are women. Symptoms include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Fibromyalgia patients have experienced dissatisfaction with available therapies, with 85% of first-line treatments failing due to efficacy and tolerability issues.
TONMYA is a first-in-class non-opioid analgesic indicated as a daily bedtime medicine for long-term use. The drug was approved on August 15, 2025, by the FDA. The TONMYA Together Support Program offers a savings program to eligible, commercially insured patients through local pharmacies and through a digital pharmacy service. Patents are expected to provide TONMYA with U.S. market exclusivity until 2034 or 2035.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.biospace.com/press-releases/tonix-pharmaceuticals-secures-commercial-payer-coverage-for-tonmya-providing-access-for-35-million-u-s-patients