Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced an agreement with a group purchasing organization that provides coverage for TONMYA to approximately 35 million U.S. commercial lives, representing about 20% of roughly 177 million commercial lives in the country.

The agreement, effective May 1, 2026, includes standard utilization management criteria for TONMYA, a cyclobenzaprine HCl sublingual tablet approved by the FDA for treating fibromyalgia in adults. The drug launched commercially in November 2025.

"This agreement is an important milestone in expanding patient access to TONMYA," said Seth Lederman, President and Chief Executive Officer of Tonix Pharmaceuticals. The company continues to pursue additional coverage across commercial and government channels.

TONMYA received FDA approval on August 15, 2025, marking the first new prescription medicine approved for fibromyalgia in more than 15 years. The drug is indicated for treatment of fibromyalgia in adults as a daily bedtime medicine for long-term use.

The company reports that TONMYA is currently covered under Medicaid in 38 states for approximately 55 million lives, representing 73% of roughly 75 million Medicaid lives. Tonix continues discussions with Medicare and Medicaid for additional coverage.

Fibromyalgia affects more than 10 million adults in the U.S., with approximately 90% being women. The chronic pain disorder results from amplified sensory and pain signaling within the central nervous system, causing symptoms including chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness.

The company offers a patient support program for eligible, commercially insured patients through local pharmacies and a digital pharmacy service. Tonix's patents for TONMYA are expected to provide U.S. market exclusivity until 2034/2035.