FDA Approves Tonix's Tonmya: First New Fibromyalgia Treatment in Over 16 Years

The U.S. Food and Drug Administration (FDA) has granted approval to Tonix Pharmaceuticals' Tonmya (cyclobenzaprine HCl), marking the first new treatment for fibromyalgia in more than 16 years. This breakthrough comes as welcome news for the estimated 10 million patients in the United States suffering from this chronic condition characterized by widespread pain and poor sleep.

A Novel Approach to Fibromyalgia Treatment

Tonmya, a sublingual formulation of cyclobenzaprine, represents a departure from existing fibromyalgia therapies. Unlike its predecessors, which focus on pain reduction or mood alteration, Tonmya targets the nonrestorative sleep associated with fibromyalgia. This approach is based on the hypothesis, first proposed by Canadian psychologist Harvey Moldofsky 50 years ago, that fibromyalgia may be more of a sleep disorder than a pain issue.

Seth Lederman, CEO and co-founder of Tonix Pharmaceuticals, explained the rationale behind Tonmya's development: "It was an audacious proposal. But he was the inspiration for us to pursue sleep quality as a target of therapy. I do think that people with fibromyalgia will recognize that pain and sleep have a vicious cycle. It's self-reinforcing: Bad sleep, worse pain. Worse pain, worse sleep."

The sublingual delivery method is a key feature of Tonmya, designed to facilitate rapid absorption into the bloodstream when taken before bedtime. This approach aims to "reduce pain quickly and durably with a tolerable safety profile," according to Dr. Andrea Chadwick of the University of Kansas Health System.

Clinical Efficacy and Approval Process

Tonmya's approval was supported by two successful Phase III studies involving nearly 1,000 patients. These double-blinded, randomized, and placebo-controlled 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, compared to those on placebo.

Common side effects observed in the late-stage studies included mouth numbness, oral discomfort, drowsiness, fatigue, mouth pain, and canker sores. Despite these, the overall safety profile was deemed tolerable by researchers.

The road to approval was not without challenges. Tonix faced a setback in 2023 when Tonmya failed to relieve pain in patients with fibromyalgia-type long COVID. However, the company persevered, and the successful outcomes in the primary fibromyalgia trials ultimately led to FDA approval.

Market Impact and Future Prospects

Tonix Pharmaceuticals plans to launch Tonmya in the U.S. market in the fourth quarter of this year. The company will initially target the 3 million people in the U.S. who have been diagnosed with fibromyalgia, with potential for expansion to an additional 7 million undiagnosed individuals.

The approval has already had a positive impact on Tonix's stock, with shares increasing by more than 10% in anticipation of the FDA's decision. The company intends to market Tonmya independently, adding 70 sales representatives to its current staff of 10.

As the first new non-opioid treatment for fibromyalgia since the approvals of Pfizer's Lyrica, Eli Lilly's Cymbalta, and AbbVie's Savella between 2007 and 2009, Tonmya enters a market with significant unmet needs. Its unique mechanism of action and delivery method position it as a potential game-changer in the field of fibromyalgia treatment.