Tonix Pharmaceuticals stock rises as TONMYA becomes available for fibromyalgia
Investing.com -- Tonix Pharmaceuticals (NASDAQ:TNXP) stock rose 8% after the company announced that its first-in-class fibromyalgia treatment TONMYA is now commercially available by prescription in the United States.
TONMYA (cyclobenzaprine HCl sublingual tablets) is a non-opioid analgesic taken once daily at bedtime for adults with fibromyalgia. The treatment was approved by the FDA on August 15, 2025, marking the first innovation for fibromyalgia treatment in over 15 years.
The drug’s approval was based on two Phase 3 clinical trials involving nearly 1,000 patients, where TONMYA significantly reduced daily pain scores compared to placebo at 14 weeks. A greater percentage of participants taking TONMYA also experienced a clinically meaningful improvement in pain after three months.
"The availability of TONMYA is a momentous day for Tonix, providing the estimated 10 million people living with fibromyalgia a novel treatment that has been shown to address the debilitating, core symptom of this disease, widespread pain," said Seth Lederman, CEO of Tonix Pharmaceuticals.
The most common adverse events in clinical trials included oral hypoesthesia, oral discomfort, abnormal product taste, and somnolence, among others. Across three Phase 3 trials with over 1,400 patients, TONMYA was generally well tolerated.
The latest Phase 3 trial results, published in Pain Medicine, included data on primary endpoints measuring pain and secondary endpoints measuring patient-reported symptoms, function, sleep disturbance, and fatigue.
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