Fibromyalgia & musculoskeletal pain
Efficacy and Safety of Sublingual Cyclobenzaprine for the Treatment of Fibromyalgia: Results From a Randomized, Double‐Blind, Placebo‐Controlled Trial
Authors' conclusion
In this phase III, randomized, controlled trial of patients with FM, treatment with TNX-102 SL was associated with significant reductions in daily pain and was safe and well tolerated.
Study context
- Population
- Patients with fibromyalgia (FM)RELIEF trial
- Participants
- 503 patients
- Comparison
- TNX-102 SL 2.8 mg for 2 weeks, then 5.6 mg for 12 weeks, vs placebo
- TNX-102 SLn = 248
- Placebon = 255reference
- Primary endpoint
- Change from baseline in the weekly average of daily pain scores
- Follow-up
- Week 14
Methodological detailsdouble-blind, placebo-controlled, phase III
- Double-blind
- Placebo-controlled
- Phase III
Primary result
As reported in the abstract
Daily pain, LS mean change from baseline
TNX-102 SL
−1.9
LS mean change · 95% CI −2.1–-1.7
Placebo
−1.5
LS mean change · 95% CI −1.7–-1.3
P = 0.01
Secondary outcomes
Patient Global Impression of Change (PGIC) · week 14
- TNX-102 SL not associated with significant improvement in PGIC
Fibromyalgia Impact Questionnaire Revised (FIQR), Patient-Reported Outcomes Measurement Information System (PROMIS) scores and daily sleep quality
- TNX-102 SL associated with improvements in FIQR scores, PROMIS scores and daily sleep quality
Safety
Treatment-emergent AEs
Oral hypoesthesia (most common AE)
Oral paresthesia
Product taste abnormal
Original publication
Efficacy and Safety of Sublingual Cyclobenzaprine for the Treatment of Fibromyalgia: Results From a Randomized, Double‐Blind, Placebo‐Controlled Trial. Arthritis Care Res (Hoboken). Published 4 July 2023. doi:10.
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