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.