Tonix Pharmaceuticals Announces U.S. Commercial Availability of TONMYA (cyclobenzaprine HCl sublingual tablets) as a First-in-Class Fibromyalgia Treatment

TONMYA is now available by prescription and available for pharmacy ordering nationwide

TONMYA is the first FDA-approved treatment for fibromyalgia in more than 15 years

TONMYA is a unique, non-opioid, once-daily bedtime analgesic that significantly reduces fibromyalgia pain and is generally well-tolerated

CHATHAM, N.J., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced today that TONMYA^TM (cyclobenzaprine HCl sublingual tablets) is now commercially available at pharmacies by prescription in the United States. TONMYA is a first-in-class treatment for fibromyalgia in adults as a non-opioid analgesic taken once daily at bedtime.

"The availability of TONMYA is a momentous day for Tonix, providing the estimated 10 million people living with fibromyalgia a novel treatment that has been shown to address the debilitating, core symptom of this disease, widespread pain,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “After more than 15 years without innovation for this disease, we are honored to bring this new treatment option to patients in partnership with the full fibromyalgia community including researchers, patients, and investigators. We are excited and motivated to make TONMYA accessible to as many patients as possible.”

The latest Phase 3 trial, RESILIENT, was published in Pain Medicine with data on primary endpoints measuring pain, and secondary endpoints measuring patient’s global impression of change, patient-reported symptoms and function, sleep disturbance, and fatigue.

“For years, fibromyalgia patients have struggled with limited treatment options that often fall short. The availability of TONMYA marks a meaningful advancement by targeting neurotransmitters thought to be involved in fibromyalgia,” said Andrea L. Chadwick, M.D., MSc, FASA, Anesthesiology, Pain, and Perioperative Medicine at The University of Kansas Health System.

"We’re truly excited about this new option for people living with fibromyalgia," said Sharon Waldrop, a person with lived experience and founder of the Fibromyalgia Association. "The availability of TONMYA provides new hope for our community and represents a crucial step forward in fibromyalgia treatment."

TONMYA was approved by the FDA on August 15, 2025.

The approval incorporated efficacy from two double-blind, randomized, placebo-controlled, Phase 3 clinical trials of nearly 1,000 patients in total that evaluated TONMYA as a bedtime treatment for fibromyalgia. Across both Phase 3 trials, TONMYA significantly reduced daily pain scores compared to placebo at 14 weeks, the primary endpoint. Additionally, a greater percentage of study participants taking TONMYA experienced a clinically meaningful (≥30%) improvement in their pain after three months, compared to placebo.