The FDA has approved cyclobenzaprine hydrochloride sublingual tablets, a first-in-class, non-opioid 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.
Ref
Efficacy and Safety of Sublingual Cyclobenzaprine for the Treatment of Fibromyalgia: Results From a Randomized, Double-Blind, Placebo-Controlled Trial- https://pubmed.ncbi.nlm.nih.gov/37165930/
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