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 pain scores compared to placebo at 14 weeks (the primary endpoint). 

In addition, a greater percentage of patients using the medication daily at bedtime experienced a clinically meaningful (≥ 30%) improvement in their pain after 3 months, compared to placebo.

Results of the RESILIENT trial were published online on July 8 in Pain Medicine. 

A third phase 3 trial (RALLY) of more than 500 patients with fibromyalgia demonstrated greater but nonsignificant treatment effect with sublingual cyclobenzaprine compared to placebo. 

Across all three trials, the medication was generally well tolerated with no serious side effects. The most common adverse events were local administration-site reactions including oral discomfort, dry mouth, and canker sores, as well as fatigue and drowsiness.

Full prescribing information is available online.