Tonix Pharma Fibromyalgia Treatment Associated with Improvement in Pain, Sleep, Fatigue
- Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) has announced the poster presentation of previously reported results from its Phase 3 RELIEF trial evaluating the TNX-102 SL tablet for the management of fibromyalgia.
- Fibromyalgia is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory, and mood issues.
- Data were presented at the 2021 American Society of Clinical Psychopharmacology Annual Meeting.
- The trial met its pre-specified primary endpoint with TNX-102 SL, significantly reducing daily pain compared to placebo. It was associated with a higher rate than placebo of more than 30% pain responders in participants with fibromyalgia.
- TNX-102 SL at 5.6 mg also showed activity in key secondary endpoints measuring improvements in sleep quality, mitigation of fatigue, and fibromyalgia-specific functional recovery.
- In addition, TNX-102 SL was well tolerated and was not associated with side effects seen with other approved oral fibromyalgia treatments, including weight gain, insomnia, nausea, or sexual dysfunction.
- "The sublingual formulation of TNX-102 SL for transmucosal absorption showed promise at the 2.8 mg dose in prior fibromyalgia studies, but we believe RELIEF provides evidence that 5.6 mg is the right dose for this patient population," said President and CEO Seth Lederman.
- The company is also conduction a second pivotal Phase 3 trial, RALLY, with interim data expected in the third quarter of 2021, followed by topline data in the first quarter of 2022.
- Price Action: TNXP shares are up 1.61% at $1.26 during the premarket session on the last check Thursday.
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