Health
Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the American Academy of Pain Medicine (AAPM) 2025 Annual Meeting
TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for transmucosal delivery and durable activity in treating fibromyalgia TNX-102 SL demonstrated statistically significant improvement in the primary endpoint of reduction in fibromyalgia pain in two pivotal double-blind randomized Phase 3 studies FDA Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia If approved by FDA, it would become the first member of a new c
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"image","alt":"Tonix Pharmaceuticals Holding Corp.","displaySize":"","headline":null,"caption":"Tonix Pharmaceuticals Holding Corp.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":140,"url":"https://media.zenfs.com/en/globenewswire.com/7794549bf2784a219c2135212e93833d"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/bONNVXBcHa.udDsOM80N_g--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE5NjtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/7794549bf2784a219c2135212e93833d","width":300,"height":140}},"lazy":false},{"type":"text","content":"TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for transmucosal delivery and durable activity in treating fibromyalgia","length":138,"tagName":"p"},{"type":"text","content":"TNX-102 SL demonstrated statistically significant improvement in the primary endpoint of reduction in fibromyalgia pain in two pivotal double-blind randomized Phase 3 studies","length":174,"tagName":"p"},{"type":"text","content":"FDA Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia","length":122,"tagName":"p"},{"type":"text","content":"If approved by FDA, it would become the first member of a new class of non-opioid analgesic drugs for fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years","length":185,"tagName":"p"},{"type":"text","content":"CHATHAM, N.J., April 07, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates presented data in a poster presentation at the AAPM 2025 Annual Meeting, held April 3-6, 2025, in Austin, Texas. A copy of the Company’s poster, titled “Sublingual Cyclobenzaprine (TNX-102 SL) for Fibromyalgia: Efficacy and Safety in Two Randomized, Placebo-Controlled Trials” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.","length":607,"tagName":"p"},{"type":"text","content":"“Designed as a bedtime treatment to target non-restorative sleep and provide durable benefits, TNX-102 SL has shown statistically significant, robust activity in reducing fibromyalgia pain in two pivotal Phase 3 studies,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Fib...