TNX-102 SL is a small, rapidly-disintegrating, under the tongue (sublingual) product candidate containing 2.8 mg of cyclobenzaprine HCl. The unique patented formulation has been designed to optimize the delivery and absorption of cyclobenzaprine for the therapeutic benefit of improving sleep quality, while minimizing the potential residual ...

2024年6月17日 · Phase 3 data showed TNX-102 SL (sublingual cyclobenzaprine HCI; Tonmya) significantly reduced daily pain and improved broad fibromyalgia symptoms. Tonix Pharmaceuticals presented a poster of their pivotal trial, RESILIENT, at the Annual European Congress of Rheumatology (EULAR) 2024 in Vienna, Austria.

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2024年10月16日 · The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD).

• TNX-102 SL is a novel sublingual investigational formulation of low dose (2.8 mg) cyclobenzaprine designed for rapid absorption and routine bedtime use • We recently completed a Phase 2b trial (BESTFIT) of TNX-102 SL, which was the first large scale evaluation of this therapeutic approach in fibromyalgia patients

Objective: To evaluate the efficacy and safety of TNX-102 SL, a once-nightly sublingual formulation of cyclobenzaprine, in reducing pain in patients with fibromyalgia (FM). Methods: RELIEF was a double-blind, randomized, placebo-controlled trial. Overall, 503 patients received TNX-102 SL 2.8 mg for 2 weeks, followed by 5.6 mg for 12 weeks (248 ...

2023年12月20日 · TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite...

2024年9月23日 · Results from the confirmatory Phase 3 RESILIENT study of TNX-102 SL demonstrated statistically significant improvement in primary endpoint of fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality

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2024年11月15日 · TNX-102 SL, a sublingual cyclobenzaprine HCl formulation, is safe and effective for treating fibromyalgia symptoms, according to study results presented at the American College of Rheumatology (ACR) Convergence 2024, held from November 14 to 19, in Washington, DC.