First New Fibromyalgia Treatment in Over 15 Years Receives FDA Approval

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For the first time in more than 15 years, the U.S. Food and Drug Administration (FDA) has approved a new treatment for fibromyalgia, a chronic pain condition that affects over 10 million adults in the U.S., most of them women. The new medicine, called Tonmya (cyclobenzaprine HCl sublingual tablets), offers a much-needed option for patients living with daily pain, fatigue and sleep problems.

“The FDA approval of Tonmya as a first-line treatment for fibromyalgia represents a landmark advancement for the millions of people in the U.S. suffering from the debilitating pain this condition causes,” Seth Lederman, M.D., chief executive officer of Tonix Pharmaceuticals, said in a statement.

Tonmya is a nonopioid medication taken once daily at bedtime. It comes as a small tablet that dissolves under the tongue, allowing it to be absorbed quickly into the bloodstream. Unlike older medicines, Tonmya was designed specifically to address both pain and poor sleep, two of the most challenging aspects of fibromyalgia.

The approval was based on results from two large phase 3 clinical trials involving nearly 1,000 patients, and bolstered by data from the new phase 3 RESILIANT trial. In these studies, people who took Tonmya reported:

• Less pain after three months compared with those who took a placebo
• Meaningful improvements in daily symptoms, with many experiencing at least a 30% reduction in pain
• Better sleep and function, helping with overall quality of life

Across three clinical trials with more than 1,400 patients, Tonmya was generally well tolerated. The most common side effects were mild and included mouth numbness or tingling, drowsiness, dry mouth and canker sores.

Experts say this approval is an important step forward. For years, patients and doctors have had very limited treatment options, leaving many struggling to manage symptoms. Tonmya provides a new approach that targets nonrestorative sleep and pain, offering renewed hope to millions living with fibromyalgia.

Tonmya is expected to be available in the U.S. by the end of this year.