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Tonix Pharmaceuticals Plans to Expand TNX-102 SL Phase 3 Program Beyond PTSD to Include Fibromyalgia
Encouraging FDA Meeting Minutes Support Phase 3 Development of TNX-102 SL 5.6 mg in FibromyalgiaNEW YORK, April 04, 2019 (GLOBE NEWSWIRE) -- Tonix
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Encouraging FDA Meeting Minutes Support Phase 3 Development of TNX-102 SL 5.6 mg in FibromyalgiaNEW YORK, April 04, 2019 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company focused on developing pharmaceutical products to treat serious neuropsychiatric and central nervous system conditions, and biological products to improve biodefense, announced today the expansion of the TNX-102 SL 5.6 mg program beyond posttraumatic stress disorder (PTSD) to include Phase 3 development for TNX-102 SL* in fibromyalgia. TNX-102 SL or Tonmya®** is Tonix's lead Phase 3 program in PTSD with the Phase 3 RECOVERY trial actively enrolling military and civilian PTSD participants.In a recent Clinical Guidance meeting with the U.S. Food and Drug Administration (FDA), Tonix received clear guidance and support to advance the development of TNX-102 SL, a non-opioid centrally-acting analgesic, for the management of fibromyalgia. Acceptable study design features were discussed to establish the safety and efficacy of TNX-102 SL 5.6 mg in a pivotal study to support the fibromyalgia indication.A lower dose of TNX-102 SL (2.8 mg) taken daily at bedtime was studied previously in fibromyalgia in a Phase 2 study and a Phase 3 study. Both studies showed clinical benefits especially in the quality of sleep improvement, however, primary analyses on pain reduction were not statistically significant. Additional data developed by Tonix in the PTSD program showed that TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) demonstrated acceptable tolerability with additional clinical benefit in pain reduction for trial participants with PTSD. There were no serious and/or unexpected adverse events reported; the most common adverse events were mostly related to local administration site reactions, such as oral hypoaesthesia and abnormal product taste.Supported by the safety and efficacy findings in PTSD, Tonix believes that increasing the dose of TNX-102 SL from 2.8 mg to 5.6 mg in the new Phase 3 fibromyalgia study will likely provide the clinical evidence to support the 5.6 mg dose as the efficacious dose for the management of fibromyalgia. The registration of TNX-102 SL 5.6 mg for the fibromyalgia indication will be supported by two positive Phase 3 studies, and the long-term safety exposure data from th...