Tonix Pharmaceuticals Completes Enrollment in Fibromyalgia Phase 3 Clinical Trial

Tonix Pharmaceuticals Completes Enrollment in Fibromyalgia Phase 3 Clinical Trial
Tonix Pharmaceuticals, a company developing next-gen therapies for disorders of the central nervous system, including fibromyalgia and post-traumatic stress disorder (PTSD), has completed enrollment in its Phase 3 AFFIRM clinical trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in fibromyalgia. TNX-102 SL is a proprietary sublingual (under the tongue) eutectic formulation of cyclobenzaprine (CBP) that is engineered to deliver a low dose of CBP to the bloodstream through mucosal membrane absorption. CBP works as an antagonist at the serotonin-2A, alpha-1 adrenergic, and histamine H1 receptors. Due to sublingual transmucosal absorption, the proprietary drug candidate avoids first-pass metabolism and decreases exposure to the active metabolite norcyclobenzaprine, a not-so-desirable molecule due to its long plasma half-life. The U.S. FDA has conditionally agreed to the name Tonmya for TNX-102 SL, but it is still an Investigational New Drug (IND) and has not yet been approved for any indication. The 12-week Phase 3 AFFIRM trial is currently being conducted in 35 U.S. locations. Its 500-patient goal per protocol has been achieved. The trial is a randomized, double-blind, placebo-controlled clinical study designed to assess the efficacy of TNX-102 SL for the management of fibromyalgia. The treatment is administered under the tongue once a day at bedtime over the course of 12 weeks. The primary outcome assessment for the AFFIRM study will be an FDA-cleared pain responder analysis, defined as the propo
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