FDA Approves Sublingual, Nonopioid Daily Treatment for Fibromyalgia

WEDNESDAY, Aug. 20, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved Tonmya (cyclobenzaprine hydrochloride) sublingual tablets for the treatment of fibromyalgia in adults.

The approval is the first for a fibromyalgia treatment in more than 15 years. It is a first-in-class, nonopioid, once-daily bedtime analgesic.

The approval was based on two phase 3 clinical trials of nearly 1,000 patients, which showed that Tonmya significantly reduced daily pain scores versus placebo at 14 weeks. Compared with those receiving placebo, a greater percentage of participants taking Tonmya experienced a clinically meaningful (≥30 percent) improvement in their pain after three months. Across three phase 3 trials involving more than 1,400 patients, Tonmya was generally well tolerated, with the most common adverse events (incidence, ≥2 percent) being numbness in the mouth, oral discomfort, abnormal product taste, drowsiness, tingling or burning in the mouth, oral pain, fatigue, dry mouth, and aphthous canker sores.

“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,” Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, said in a statement. “We are hopeful that effectively treating pain with Tonmya could help improve the lives of people with this chronic syndrome.”

Approval of Tonmya was granted to Tonix Pharmaceuticals. 

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