The U.S. Food and Drug Administration (FDA) has approved Tonmya (cyclobenzaprine hydrochloride) sublingual tablets as a daily treatment for adults with fibromyalgia, marking the first new therapy for the condition in more than 15 years.
Tonmya is a first-in-class, nonopioid analgesic designed for once-daily use at bedtime. Its approval is based on results from two phase 3 clinical trials involving nearly 1,000 patients. Findings showed the medication significantly reduced daily pain scores compared with placebo after 14 weeks.
More participants in the Tonmya group also achieved a clinically meaningful reduction—defined as at least 30 percent improvement—in pain levels after three months.
Across three phase 3 studies including more than 1,400 participants, Tonmya demonstrated a favorable safety profile. The most commonly reported side effects, occurring in at least 2 percent of patients, included mouth numbness, oral discomfort, altered taste, drowsiness, tingling or burning sensations in the mouth, fatigue, dry mouth, oral pain, and canker sores.
Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, the manufacturer of Tonmya, emphasized the importance of the FDA’s decision.
“Fibromyalgia has long lacked new treatment options,” Lederman said in a statement.
“We believe Tonmya offers a novel approach to managing chronic pain and has the potential to improve quality of life for patients living with this complex condition.”
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