FDA Approves Tonmya for Adult Fibromyalgia

The FDA has approved Tonmya (cyclobenzaprine HCl sublingual tablet) for the treatment of fibromyalgia in adults, making it the first new FDA-approved treatment for the disease in more than 15 years, according to a recent news release. Tonmya is expected to be available for patients in the fourth quarter of 2026.

Fibromyalgia is a chronic, incurable disease that causes increased sensitivity to pain and tenderness throughout the body. The pain, often described by patients as aching, burning or throbbing, is most felt in the arms, legs, chest, abdomen, back and buttocks. Other symptoms may include fatigue, digestive issues and brain fog.

Approximately 10 million people in the United States have fibromyalgia, 80% of whom are women. Fibromyalgia patients also have double the medical costs compared with the general U.S. population due to increased specialist visits, diagnostic testing and indirect costs related to lost productivity.

“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,” Philip Mease, M.D., director of Rheumatology Research at the Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, said 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.”

Tonmya is administered as a 2.8 mg sublingual tablet once daily at bedtime, according to the prescribing information. It is a tertiary amine tricyclic that bypasses first-pass liver metabolism and enters the bloodstream through mucosal membranes under the tongue.

The starting dose of 2.8 mg is given on days 1 to 14. On day 15 and thereafter, patients can take 5.6 mg, which is the maximum recommended dosage. For geriatric patients and patients with hepatic impairment, the recommended dosage is 2.8 mg daily. Patients should avoid eating or drinking for at least 15 minutes after taking Tonmya. If a dose is missed, it should be taken the following evening.

The safety and effectiveness of Tonmya were determined during the RELIEF and RESILIENT trials, in which at least 30% of participants reported clinically meaningful improvement in their pain after three months on Tonmya, when compared to placebo, according to an investor call held this morning.

Researchers enrolled 1,474 patients ages 18 to 65 who met the 2016 American College of Rheumatology (ACR) criteria for diagnosis of fibromyalgia, the prescribing information says.

Adverse reactions occurred in at least 2% of patients, with the most common being oral hypoesthesia (23%), oral discomfort (9%) and abnormal product taste (9%).

“I know firsthand how the chronic pain of fibromyalgia significantly disrupts my patients’ lives,” Andrea L. Chadwick, M.D., MSc, FASA, Anesthesiology, Pain, and Perioperative Medicine at The University of Kansas Health System, said in the news release. “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.”

Tonix has not yet disclosed pricing for Tonmya.