Responder Compared to Mean Change Analyses in a Fibromyalgia Phase 2b Clinical Study of Bedtime Rapidly Absorbed Sublingual Cyclobenzaprine (TNX-102 SL)

• Fibromyalgia is characterized by symptoms that include widespread pain and sleep disruption • Clinical studies that rely on patient self-reported outcome measures such as pain scales may be analyzed by responder analysis (comparisons of proportions of treated patients achieving a predefined clinically meaningful improvement threshold) and by group mean changes • In a phase 2b trial of TNX-102 SL,* a proprietary eutectic sublingual (SL) tablet formulation of low-dose cyclobenzaprine HCl (2.8 mg) in fibromyalgia patients (BESTFIT), we compared responder analyses to group mean change analyses for the evaluation of changes in pain and fibromyalgia symptoms