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 cos

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