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Tonix Pharmaceuticals submits NDA for TNX-102 SL, a non-opioid, centrally-acting analgesic for fibromyalgia, after two Phase 3 studies showed significant pain reduction. If approved, TNX-102 SL would be the first new drug for fibromyalgia in over 15 years.

Tonix Pharmaceuticals submitted a New Drug Application (NDA) to the FDA for TNX-102 SL, a non-opioid treatment for fibromyalgia, based on two Phase 3 studies showing significant pain reduction. If approved, it would be the first new fibromyalgia drug in over 15 years, targeting non-restorative sleep characteristic of the condition.

Tonix Pharmaceuticals CEO, Dr. Seth Lederman, participated in the 'RECOVER Treating Long COVID (TLC) - Navigating the Pathway Forward' workshop, discussing clinical trial endpoints for Long COVID therapeutics. Lederman highlighted the potential of Patient Global Impression of Change (PGIC) as a primary endpoint for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)-type Long COVID, drawing parallels to Progression-Free Survival (PFS) in cancer drug development.

Tonix Pharmaceuticals CEO Seth Lederman participated in the 'Endpoints' panel at the RECOVER Treating Long COVID workshop, discussing clinical trial endpoints for potential Long COVID therapeutics. Lederman recommended validating Patient Global Impression of Change (PGIC) as a primary endpoint for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)-type Long COVID trials, drawing parallels to the regulatory pathway for cancer drugs.

Tonix Pharmaceuticals presented data on TNX-102 SL, a sublingual cyclobenzaprine HCl, at the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems. The eutectic formulation of TNX-102 SL is expected to provide market exclusivity until at least 2034. The U.S. FDA New Drug Application (NDA) submission is on track for October 2024, with a 2025 PDUFA date for FDA decision. The Phase 3 RESILIENT study results showed significant improvement in fibromyalgia pain and sleep quality.

Tonix Pharmaceuticals presented TNX-102 SL data at PDDS 2024, highlighting its eutectic formulation technology, pharmacokinetic properties, and market exclusivity until 2034. The U.S. FDA NDA submission is scheduled for October 2024, with a 2025 PDUFA date. The Phase 3 RESILIENT study results showed significant improvement in fibromyalgia pain and sleep quality.

Tonix Pharmaceuticals appoints Thomas Englese as EVP of Commercial Operations, with a focus on advancing TNX-102 SL for fibromyalgia ahead of an NDA submission in October 2024.

Tonix Pharmaceuticals launches educational campaign on non-oral migraine treatments, highlighting faster relief via nasal and injectable options, addressing gastroparesis' impact on oral medication efficacy.

Tonix Pharmaceuticals received FDA's conditional acceptance for Tonmya™, a sublingual tablet for fibromyalgia management, following positive Phase 3 trials. Tonmya significantly reduced pain and improved symptoms. An NDA submission is planned for 2024, aiming for U.S. market exclusivity until 2034/2035.

TNX-102 SL, a non-opioid analgesic, showed significant pain reduction over placebo in a Phase 3 trial and positive effects across secondary endpoints. Tonix Pharmaceuticals plans to submit an NDA to the FDA in 2024 for fibromyalgia treatment. The company also develops treatments for Long COVID, cocaine intoxication, and other diseases, with several products in clinical trials.