American biopharmaceutical company Tonix Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults.     

Fibromyalgia is a chronic pain disorder caused by amplified sensory and pain signaling within the central nervous system. It afflicts an estimated 10 million adults in the US, approximately 80 percent of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep (waking up tired and unrefreshed), fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled.  

Tonmya is the first new FDA-approved therapy for the treatment of fibromyalgia in over 15 years.  It is a first-in-class, non-opioid, once-daily bedtime analgesic with a unique sublingual (under the tongue) formulation that is designed for rapid absorption into the bloodstream.

“The FDA approval of Tonmya as a first-line treatment for fibromyalgia represents a landmark advancement for the millions of people in the US suffering from the debilitating pain this condition causes,” said Seth Lederman, CEO of Tonix Pharmaceuticals.

“At Tonix, we recognised the transformative potential of pursuing a new approach with Tonmya for fibromyalgia, a chronic overlapping pain condition (COPC), that has gone without innovation for many years. We are hopeful that effectively treating pain with Tonmya could help improve the lives of people with this chronic syndrome,” he added.

The approval was based on results from two double-blind, randomised, placebo-controlled, Phase 3 clinical trials of nearly 1,000 patients in total that evaluated Tonmya as a bedtime treatment for fibromyalgia. Across both Phase 3 trials, Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks, the primary endpoint. Additionally, a greater percentage of study participants taking Tonmya experienced a clinically meaningful improvement in their pain after three months, compared to placebo.

Across three Phase 3 clinical trials with over 1,400 patients evaluated, Tonmya was generally well-tolerated. The most common adverse events included oral hypoesthesia (numbness in the mouth), oral discomfort, abnormal product taste, somnolence (drowsiness), oral paresthesia (tingling, pricking or burning in the mouth), oral pain, fatigue, dry mouth, and aphthous ulcer (canker sore).

Tonmya is expected to be available for adult patients in the US with fibromyalgia beginning in the fourth quarter of this year.