FDA Approves First-in-Class Drug for Fibromyalgia

The FDA has approved cyclobenzaprine hydrochloride sublingual tablets (Tonmya, Tonix Pharmaceuticals), a first-in-class, nonopioid treatment for adults with fibromyalgia , a chronic pain syndrome that affects more than 10 million Americans , roughly 80% of whom are women.

The medication, taken once-daily at bedtime, targets nonrestorative sleep, a root cause of pain, fatigue, and brain fog in fibromyalgia. It's the first new FDA-approved therapy for the treatment of fibromyalgia in over 15 years. Tonmya (formerly TNX-102 SL) is expected to be available in the fourth quarter of this year.

In two double-blind, randomized, placebo-controlled, phase 3 trials ( RELIEF and RESILIENT ) of nearly 1000 patients with fibromyalgia, sublingual cyclobenzaprine significantly reduced daily