Tonix completes clinical stage of Phase 3 RESILIENT study of TNX-102 SL

Tonix Pharmaceuticals Holding announced the completion of the clinical phase of the Phase 3 registration-quality, double-blind, placebo-controlled RESILIENT1 study of TNX-102 SL2 5.6 mg for the management of fibromyalgia. A total of 457 patients were enrolled in this multi-site study in the U.S. Topline results are expected in late December 2023. If successful, it is expected to be the final, well-controlled efficacy trial required for submission of a New Drug Application for approval by the U.S. Food and Drug Administration. “There are an estimated 6-12 million individuals in the U.S. suffering from this debilitating condition, most of whom are women,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “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.”