New Fibromyalgia Treatment: FDA Approves Once-Daily Nonopioid Analgesic TNX-102 SL

The US Food and Drug Administration (FDA) has approved cyclobenzaprine hydrochloride sublingual tablets (Tonmya; Tonix Pharmaceuticals) for the treatment of fibromyalgia in adults, marking the first new therapy for the condition in more than 15 years, according to a company news release.

“The FDA approval of Tonmya as a first-line treatment for fibromyalgia represents a landmark advancement for the millions of people in the U.S. suffering from the debilitating pain this condition causes,” said Seth Lederman, MD, chief executive officer of Tonix Pharmaceuticals, in the news release. “At Tonix, we recognized the transformative potential of pursuing a new approach with Tonmya for fibromyalgia, a chronic overlapping pain condition that has gone without innovation for many years.”

How does Tonmya work?

Tonmya, previously known as TNX-102 SL, is a first-in-class, non-opioid, once-nightly analgesic formulated for sublingual administration, designed for rapid absorption and reduced production of the long half-life metabolite norcyclobenzaprine. According to Tonix, the drug’s mechanism targets nonrestorative sleep, a core feature of fibromyalgia, with potential to improve associated pain and functional impairment.

What were the trial results?

The approval was supported by efficacy data from 2 pivotal phase 3 randomized, double-blind, placebo-controlled trials (RELIEF and RESILIENT), which enrolled nearly 1000 adults with fibromyalgia. In both studies, participants receiving Tonmya experienced significantly greater reductions in daily pain intensity scores over 14 weeks compared with placebo. A higher proportion of patients in the active-treatment group also achieved at least a 30% improvement in pain.

“For many years, rheumatologists like myself and other healthcare professionals have had to manage fibromyalgia with limited options that do not adequately meet treatment needs for the majority of patients,” said Philip Mease, MD, director of rheumatology research at the Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, in the news release. “Tonmya is a novel treatment approach that targets nonrestorative sleep that is characteristic of fibromyalgia and can impact core symptoms, specifically pain.”

Safety findings across 3 phase 3 trials (n >1400) indicated that Tonmya was generally well tolerated. The most common adverse events (incidence ≥2% and higher than placebo) included oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

How will this approval impact the fibromyalgia patient population?

Fibromyalgia affects an estimated 10 million US adults, approximately 80% of whom are women. The disorder is characterized by chronic widespread pain, fatigue, nonrestorative sleep, cognitive dysfunction, and mood disturbances, and is associated with significant reductions in quality of life and increased healthcare utilization.

“I know firsthand how the chronic pain of fibromyalgia significantly disrupts my patients’ lives,” said Andrea L. Chadwick, MD, MSc, FASA, anesthesiology, pain, and perioperative medicine at The University of Kansas Health System. “Treatments that are processed through the liver can result in metabolites that could affect a medicine’s efficacy and safety over time. Tonmya is administered sublingually which is designed to reduce pain quickly and durably with a tolerable safety profile.”

Sharon Waldrop, founder of the Fibromyalgia Association and a person with lived experience with fibromyalgia said this is a major milestone for patients.

"For over 15 years, this community has been underserved and waiting for new treatment options. This approval is a promising step forward and brings renewed hope to millions.”

When will Tonmya be available in the U.S.?

Tonmya is expected to be commercially available in the United States in the fourth quarter of 2025.

Reference

Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals announces FDA approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia [news release]. GlobeNewswire. August 15, 2025. Accessed August 15, 2025. https://ir.tonixpharma.com/news-releases/news-release-details/tonix-pharmaceuticals-announces-fda-approval-tonmyatm