Tonix Pharmaceuticals CEO Discusses New Drug Application for Fibromyalgia Treatment

Proactive - Interviews for investors

Dr. Seth Lederman, CEO of Tonix Pharmaceuticals joined Steve Darling from Proactive to share news about the company's submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration for its drug TNX-102 SL, a non-opioid analgesic designed to treat chronic pain associated with fibromyalgia. TNX-102 SL demonstrated statistically significant pain reduction in two Phase 3 studies and was well tolerated by patients. Dr. Lederman highlighted that the drug was granted Fast Track designation by the FDA in July 2024, a process aimed at speeding up the review of new treatments for serious conditions that address unmet medical needs. If approved, TNX-102 SL would be the first new class of fibromyalgia medication in over 15 years, offering hope to a large patient population that has struggled with limited treatment options. The drug, designed to be taken at bedtime on a daily basis, targets the non-restorative sleep characteristic of fibromyalgia, which Tonix believes is key to alleviating the condition's widespread pain. The company has also announced it has received its first payment from the Defense Threat Reduction Agency within the U.S. Department of Defense, to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. The previously announced award is for up to 34 million dollars over five years. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #FibromyalgiaTreatment #SethLederman #NDA #FDAApproval #DrugDevelopment #BiotechNews #TNX102SL #AntiviralDrugs #PharmaNews #DODContract #ClinicalTrials #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews