Single-Dose Pharmacokinetic Assessment of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets): Results From Randomized, Open-Label Studies in Healthy Volunteers.

In a previous Phase 3 FM study, treatment with TNX‐102 SL 2.8 mg showed clinically meaningful efficacy across most secondary and sensitivity analyses, and the study's primary efficacy endpoint (30% responder analysis) showed a positive trend ( P = 0.095) but was not statistically significant. 15 Based on these results, we expected that a higher dose of TNX‐102 SL (i.e., 5.6 mg) would have the potential to establish substantial evidence of efficacy and maintain an acceptable safety and tolerability profile in patients with FM.

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