Tonix Pharmaceuticals completes enrollment in Phase 3 RESILIENT trial

Tonix Pharmaceuticals announced that it has completed enrollment of its potentially final, confirmatory Phase 3 RESILIENT trial of TNX-102 SL 5.6 mg in fibromyalgia and expects topline data next quarter. A total of 457 participants were randomized. If successful, the company believes this will 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. “The completion of enrollment in our Phase 3 RESILIENT trial is a significant milestone for both Tonix and the fibromyalgia community,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “Currently-approved treatments have not fully met the needs of fibromyalgia patients and there has not been a new FDA-approved therapy for the condition since 2009. TNX-102 SL has the potential to be a new non-addictive, non-opioid bedtime medication with broad spectrum symptom coverage and which can be used on a chronic basis for the management of fibromyalgia. With all other clinical, nonclinical and CMC requirements for an NDA submission achieved, we are looking forward to the upcoming data readout and an expeditious filing of an NDA.”