Tonix Pharmaceuticals (NASDAQ:TNXP) met its target enrollment of 470 patients in its Phase 3 study of TNX-102 SL for the management of fibromyalgia.
TNX-102 SL is a non-opioid analgesic, administered daily at bedtime. Patients will receive a 2.8 mg dose, or placebo, for two weeks, after which the dose will be increased to 5.6 mg, or placebo, for 12 weeks. The primary endpoint is daily diary pain severity score change from baseline to week 14.
Tonix expects an interim analysis of the first 50% of randomized participants evaluable for efficacy in September 2020. Based on the current sample size, topline data are expected in the fourth quarter of 2020.
“The completion of enrollment in our Phase 3 RELIEF trial is a significant accomplishment for Tonix as well as for the fibromyalgia community,” Dr. Seth Lederman, Tonix’s president and CEO, said in a statement.
“We are developing a new, non-addictive treatment option for fibromyalgia because there are still inadequate therapy options for this disorder despite its prevalence as one of the most common chronic pain conditions,” he added.
