Summary

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• This summary is based on the review of two randomized controlled trials. ^[1-2]
• Tonmya (cyclobenzaprine hydrochloride sublingual tablets) is indicated for the treatment of fibromyalgia in adults.
• In patients with fibromyalgia, cyclobenzaprine hydrochloride sublingual tablets demonstrated greater reductions in daily pain scores at week 14 compared with placebo (Least Square (LS) mean change -1.9 [95% confidence interval (CI) -2.1, -1.7] vs -1.5 [95% CI -1.7, -1.3]; P = 0.01) and in the primary pain endpoint (mean standard error [SE], -1.8 [0.12] vs -1.2 [0.12]; P < 0.001).
• Secondary outcomes showed that cyclobenzaprine hydrochloride sublingual tablets was associated with improvements in Fibromyalgia Impact Questionnaire–Revised (FIQR) scores, Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance and Fatigue scores, and daily sleep quality; one study additionally reported significant improvements in Patient Global Impression of Change (PGIC) (P ≤ 0.001), FIQR Symptoms and Function domains (P ≤ 0.001), PROMIS instruments (P ≤ 0.001), and daily diary sleep quality scores (P ≤ 0.001).
• No significant differences in effectiveness outcomes among different population types or subgroups were reported.
• In patients with fibromyalgia, treatment-emergent Adverse Events (AEs) were reported in 59.7% with cyclobenzaprine hydrochloride sublingual tablets vs 46.3% with placebo; common systemic Treatment-Emergent Adverse Events (TEAEs) included COVID-19 (4.3% vs 3.1%), headache (3.0% vs 1.8%), and somnolence (3.0% vs 1.3%).
• Local administration-site AEs with cyclobenzaprine hydrochloride sublingual tablets included oral hypoesthesia (17.3% and 23.4% vs 0.4%), oral paresthesia (5.6% and 6.9% vs 0.4% and 0.9%), and product taste abnormal (4.4% and 11.3% vs 0.4% and 0.9%).