FDA Approves First New Fibromyalgia Treatment in Over 16 Years

The U.S. Food and Drug Administration (FDA) has approved Tonmya (cyclobenzaprine HCl), the first new treatment for fibromyalgia in more than 16 years. Developed by Tonix Pharmaceuticals, this breakthrough medication offers a novel approach to managing the chronic pain condition that primarily affects women.

A Long-Awaited Breakthrough

Tonix Pharmaceuticals, founded in 2010 with the specific goal of developing a fibromyalgia treatment, has achieved a significant milestone with the FDA's endorsement of Tonmya. The approval comes after a 15-year journey, marking a major advancement in the field of fibromyalgia treatment.

"I've been working on this particular idea for more than 25 years," said Seth Lederman, Tonix's CEO and co-founder. "It's a very hard condition to study and that's why we're so excited to finally be at the end."

Tonmya is a first-in-class medication formulated as a once-daily bedtime treatment taken sublingually for rapid absorption into the bloodstream. This unique delivery method distinguishes it from existing treatments and is designed to address the nonrestorative sleep associated with fibromyalgia.

Mechanism of Action and Clinical Efficacy

As a tertiary amine tricyclic antidepressant, Tonmya offers a new mechanism of action compared to existing fibromyalgia treatments. While drugs like Pfizer's Lyrica, Eli Lilly's Cymbalta, and AbbVie's Savella focus on pain signal reduction or altering brain chemistry, Tonmya targets the sleep disturbances often associated with the condition.

The FDA approval was based on two successful Phase 3 studies involving nearly 1,000 patients. These trials demonstrated that Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks. Additionally, a greater percentage of participants taking Tonmya achieved a clinically meaningful 30% or better improvement in their pain after three months.

Dr. Andrea Chadwick of the University of Kansas Health System highlighted the advantage of Tonmya's sublingual delivery: "It is designed to reduce pain quickly and durably with a tolerable safety profile. Treatments that are processed through the liver can result in metabolites that could affect a medicine's efficacy and safety over time."

Market Potential and Company Strategy

Tonix Pharmaceuticals plans to market Tonmya independently, with plans to expand its sales force from 10 to 80 representatives. The company is targeting the 3 million people in the U.S. diagnosed with fibromyalgia, with potential for expansion to an estimated additional 7 million undiagnosed individuals.

While the pricing strategy for Tonmya has not been announced, Lederman expressed flexibility in their approach: "We do believe that this could be—maybe should be—a big pharma drug. But we've also seen that the trend in the industry is that more and more—particularly in the [central nervous system] space—that companies have to launch the drug themselves."

The approval of Tonmya represents a significant step forward in fibromyalgia treatment, offering new hope to millions of patients who have long awaited more effective therapeutic options.