Tonix Pharmaceuticals has concluded the Phase III RESILIENT study’s clinical phase of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6mg to manage fibromyalgia.
The double-blind, placebo-controlled, registration-quality and multi-site trial has enrolled 457 patients to evaluate the safety and efficacy of TNX-102 SL in managing this condition.
This two-arm study randomised subjects across 33 sites in the US.
The initial two weeks of treatment include a run-in period in which subjects begin on TNX-102 SL 2.8mg (one tablet) dose or placebo.
Later, all participants increased their dose to TNX-102 SL 5.6mg or two placebo tablets for the remaining 12 weeks.
Daily diary pain severity score change to week 14 from baseline for TNX-102 SL 5.6mg against placebo is the trial’s primary endpoint. It will be analysed by mixed model repeated measures with multiple imputations.
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Topline results from the trial are anticipated by the end of December.
If successful, RESILIENT is anticipated to serve as the final, well-controlled efficacy trial required for submitting a new drug application (NDA) to receive approval from the US Food and Drug Administration (FDA).
Tonix Pharmaceuticals CEO Seth Lederman said: “TNX-102 SL is a centrally-acting, non-opioid analgesic bedtime medication designed to be used on a chronic basis for the management of fibromyalgia.
“We believe TNX-102 SL works by improving sleep quality, which leads to improvement of other symptoms. In previous studies, TNX-102 SL showed broad coverage across the symptoms of fibromyalgia, including chronic widespread pain, fatigue and sleep disturbance.”