The FDA has approved cyclobenzaprine hydrochloride sublingual tablets (Tonmya, Tonix Pharmaceuticals), a first-in-class, non-opioid treatment for adults with fibromyalgia, a chronic pain syndrome that affects more than 10m Americans, around 80% of whom are women.
Medscape reports that the medication, taken once-daily at bedtime, targets non-restorative sleep, a root cause of pain, fatigue and brain fog in fibromyalgia, and is the first new FDA-approved therapy for the treatment of fibromyalgia in more than 15 years.
Tonmya (formerly TNX-102 SL) is expected to be available in the fourth quarter of this year.
In two double-blind, randomised, placebo-controlled, phase 3 trials (RELIEF and RESILIENT) of nearly 1 000 patients with fibromyalgia, sublingual cyclobenzaprine significantly reduced daily pain scores compared with 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 three months, compared with placebo.
Results of the RESILIENT trial were published online in Pain Medicine.
A third phase 3 trial (RALLY) of more than 500 patients with fibromyalgia demonstrated greater but non-significant treatment effect with sublingual cyclobenzaprine compared with 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.
Medscape article – FDA Approves First-in-Class Drug for Fibromyalgia (Open access)
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