Tonix Pharma Gets IND Clearance To Begin Clinical Trials Of TNX-102 SL In Treatment Of Long COVID

(RTTNews) - Tonix Pharmaceuticals Holding Corp. (TNXP) announced FDA has cleared the Investigational New Drug application to support a phase 2 clinical trial with TNX-102 SL1 as a potential treatment for a subset of patients with Long COVID whose symptoms overlap with fibromyalgia. The phase 2 study will be a double-blind randomized, placebo-controlled 14-week trial to evaluate the safety and efficacy of sublingual TNX-102 SL 5.6 mg daily at bedtime in the treatment of patients with multi-site pain. There is currently no approved drug for the treatment of Long COVID.

The company said the trial will be conducted at approximately 30 sites to enroll approximately 470 patients who will be randomized in a 1:1 ratio to treatment with TNX-102 SL or placebo tablets.