A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia
Latest Information Update: 15 Apr 2025
At a glance
- Drugs Cyclobenzaprine (Primary)
- Indications Fibromyalgia
- Focus Registrational; Therapeutic Use
- Acronyms RELIEF
- Sponsors Tonix Pharmaceuticals Inc
- 07 Apr 2025 According to a Tonix Pharmaceuticals media release, company presented data from this study and RESILIENT study, in a poster presentation session at the American Academy of Pain Medicine (AAPM) 2025 Annual Meeting, held April 3-6, 2025, in Austin, Texas.
- 04 Mar 2025 According to a Tonix Pharmaceuticals media release, company presented data in an oral presentation at the 7th International Congress on Controversies in Fibromyalgia, held March 3-4, 2025, in Vienna, Austria.
- 23 Dec 2024 According to a Tonix Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on marketing approval for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia.