Tonix Pharmaceuticals Holding Corp., a fully integrated biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has approved Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults.

Tonmya is a first-in-class, non-opioid, once-daily bedtime analgesic with a unique sublingual formulation designed for rapid absorption into the bloodstream. It is the first new FDA-approved therapy for fibromyalgia in more than 15 years.

“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,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.

“At Tonix, we recognized 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.”

“The chronic pain of fibromyalgia is debilitating to every aspect of a person’s life, including causing sleep disturbance and fatigue, all of which can negatively impact someone’s ability to carry out their daily activities,” said Sharon Waldrop, a person with lived experience and founder of the Fibromyalgia Association. “For over 15 years, this community has been underserved and waiting for new treatment options. This approval is a promising step forward and brings renewed hope to millions.”

The FDA approval was supported by efficacy results from two double-blind, randomized, placebo-controlled Phase 3 clinical trials enrolling nearly 1,000 patients in total.

“For many years, rheumatologists like myself and other healthcare professionals have had to manage fibromyalgia with limited options that do not adequately meet treatment needs for the majority of patients,” said Philip Mease, Director of Rheumatology Research at Providence Swedish Medical Center and Clinical Professor at the University of Washington School of Medicine. “Tonmya is a novel treatment approach that targets nonrestorative sleep that is characteristic of fibromyalgia and can impact core symptoms, specifically pain.”

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