Tonix Pharmaceuticals (NASDAQ:TNXP) CEO Dr. Seth Lederman recently recently shared groundbreaking news during an interview with Steve Darling from Proactive. The company has achieved highly positive results in their clinical trial targeting Fibromyalgia, a chronic pain disorder affecting approximately 10 million Americans and for which satisfactory treatments are often lacking. TNX 102 SL, Tonix's drug candidate, demonstrated remarkable efficacy in the second phase three clinical trial.
The primary pain endpoint achieved an exceptionally low p-value of 0.00005. What's even more promising is that TNX 102 SL is a non-opioid medication with no recognized addictive potential. In addition to addressing pain, the drug also effectively tackled other Fibromyalgia symptoms such as fatigue and sleep disturbances. Lederman informed Proactive that the company's next steps involve filing a new drug application (NDA) for FDA approval.
They anticipate a pre-NDA meeting scheduled for the first half of 2024. This groundbreaking development places Tonix Pharmaceuticals at the forefront of Fibromyalgia treatment innovation, providing hope to millions of individuals suffering from the condition. Further updates on this transformative drug are eagerly anticipated in 2024.