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Clinical Trial Summary

The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia.

The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT02829814
Study type Interventional
Source Tonix Pharmaceuticals, Inc.
Status Terminated
Phase Phase 3
Start date July 2016
Completion date September 2016

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