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Tonix's TNX 102-SL Could Offer New Hope of Pain Relief Without Narcotics for Fibromyalgia Sufferers
This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice. CHATHAM, NJ / ACCESSWIRE / December 9, 2024 / Fibromyalgia, the chronic pain condition that plagues approximately ten million Americans is in need of new drug treatment options. The existing approved drugs on the market often aren't enough. Unfortunately, many patients, at the direction of their doctors, end up taking opioids as a last resort to manage fibromyalgia. Click here for a 6-minute video of Seth Lederman, MD, reviewing the status of TNX 102-SL for fibromyalgiaOpioids come with their own set of problems. Opioids can be addictive and, over time, life-threatening. Of patients prescribed opioids for chronic pain, 21% to 29% misuse them, while about 8% to 12% develop opioid use disorder.Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is on a mission to bring a better drug for fibromyalgia to the market, which is estimated to grow to a value of $4.13 billion globally in 2032 from $2.8 billion in 2024. The biopharmaceutical company submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in October for TNX-102 SL (cyclobenzaprine HCl sublingual tablets), Tonix's drug candidate for the management of fibromyalgia.Tonix expects to hear a decision on NDA acceptance by the FDA in mid-December. If the NDA is accepted, Tonix said the FDA could commit to a decision on approval in 2025, which means TNX-102 SL could be on the market as early as next year, giving fibromyalgia sufferers a much-needed new non-opioid option. As it stands, Tonix believes 85% of fibromyalgia patients fail their first-line therapy, and 79% are on multiple therapies.Fast Track Status The FDA previously granted TNX-102 SL Fast Track designation which expedites the review of important new drugs intended to treat \"serious conditions\" and address unmet medical needs. Fast Track designation has the goal of bringing new treatments to patients sooner. In granting Fast Track, FDA recognized fibromyalgia a...