Tonix Pharmaceuticals (NASDAQ:TNXP) CEO Seth Lederman joins Proactive's Stephen Gunnion after the company received FDA Fast Track designation for its drug candidate, TNX-102, aimed at managing fibromyalgia.
Lederman expressed delight at the FDA's recognition of TNX-102, highlighting that this designation will expedite interactions with the FDA as they seek marketing approval, expected in 2025. He explained that fibromyalgia is a serious chronic pain condition affecting mostly women, with about 10 million patients in the United States alone.
Discussing the market opportunity, Lederman mentioned that over 2 million people are currently diagnosed and treated for fibromyalgia, indicating a significant market potential. TNX 102 stands out in the market due to its impact on pain, sleep, and fatigue, with fewer side effects compared to existing treatments.
Recent trials showed statistically significant improvements in these areas, positioning TNX 102 as a promising treatment. Tonix Pharmaceuticals (NASDAQ:TNXP) is preparing a new drug application, aiming for a submission in the second half of 2024 and anticipating FDA approval in 2025.
The Fast Track designation may also lead to a priority review, potentially reducing the review time to six months.