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6h ago

FDA Approves First New Fibromyalgia Treatment in 15 Years

U.S. availability is slated for Q4 2025 under patents that extend into the next decade.

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Fibromyalgia is a chronic pain condition that affects ten million adults in the US, with 80% of those affected women. Credit: Jo Panuwat D/Shutterstock.com.
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(Stock.Adobe.com)

Overview

  • Two pivotal Phase III trials, RELIEF (503 adults) and RESILIENT (457 participants), demonstrated significant reductions in daily pain scores versus placebo over 14 weeks.
  • Tonmya is a non-opioid, patented sublingual cyclobenzaprine formulation designed for once-daily bedtime dosing to promote rapid absorption and minimize long-acting metabolites.
  • Across three Phase III studies involving over 1,400 patients, Tonmya was generally well tolerated, with oral numbness, abnormal taste and drowsiness among the most common side effects.
  • Tonix holds U.S. patents securing market exclusivity until 2034, with potential extensions to 2044 under related applications.
  • Fibromyalgia patient groups welcomed the approval as a crucial new option for the condition, which affects an estimated ten million U.S. adults.