Tonix Discontinues Development For Fibromyalgia Drug After Phase 3 Trial Fails

Tonix Discontinues Development For Fibromyalgia Drug After Phase 3 Trial Fails
tonixlogoNew York based Tonix Pharmaceuticals announced it will halt the development of its TNX-102 SL drug candidate for the treatment of fibromyalgia after it failed to achieve target endpoints in the AFFIRM Phase 3 clinical study. The 12-week randomized, double-blind, placebo-controlled trial had 519 participants enrolled at 35 centers in the U.S. Earlier trial results appeared promising. TNX-102 SL - Tonmya for Fibromyalgia Background In June, the U.S. Food and Drug Administration (FDA) conditionally accepted the proposed trade name Tonmya for TNX-102 SL as a candidate for managing fibromyalgia. The company said a request for proprietary name review for Tonmya would be submitted once a fibromyalgia New Drug Application (NDA) was approved by the FDA. TNX-102 SL is a  sublingual (under the tongue) formulation of cyclobenzaprine HCL 2.8 mg intended to be taken daily at bedtime. Because non-restorative sleep a characteristic fibromyalgia symptom that contributes to the development of widespread pain and other symptoms, the therapy is designed to increase restful sleep. The drug acts on multiple neurotransmitter systems intrinsic to sleep physiology, with potent blocking activity at the serotonin 2A receptor, the alpha-1 adrenergic receptor, and the histamine-1 receptor. It is designed to deliver cyclobenzaprine to the bloodstream rapidly and to bypass first-pass hepatic metabolism. Cyclobenzap
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