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Tonix Pharmaceuticals, Set to File an NDA for Tonmya for the Management of Fibromyalgia, is Planning Expected Launch in 2H 2025
Tonix Pharmaceuticals (NASDAQ:TNXP)is preparing to file a New Drug Application (NDA) for Tonmya, its fibromyalgia management drug, in the second half of 2024. The company anticipates FDA approval and commercial launch in the second half of 2025. Tonmya, a non-opioid sublingual tablet, has shown significant improvements in fibromyalgia pain, sleep quality, and other symptoms in clinical trials.
The fibromyalgia market, valued at over $3 billion globally in 2023, has not seen a new FDA-approved drug in over 15 years. Tonix aims to compete in this growing market, which is expected to expand at a 3.8% CAGR from 2024 to 2030. With Tonmya's unique mechanism of action and promising clinical results, Tonix is positioned to potentially disrupt the market currently dominated by generic versions of previous blockbuster drugs.
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