Tonix Pharmaceuticals Announces U.S. FDA Approval Of Tonmya™ (Cyclobenzaprine HCl Sublingual Tablets) As A New Therapy for Patients With Fibromyalgia

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 therapy taken once daily at bedtime. It has a unique sublingual formulation designed for rapid absorption and is the first new FDA-approved treatment for fibromyalgia in more than 15 years.

The approval was based on results from two double-blind, randomized, placebo-controlled Phase 3 trials that included nearly 1,000 patients. In these studies, Tonmya demonstrated a significant reduction in daily pain scores compared to placebo at 14 weeks, which was the primary endpoint. More patients receiving Tonmya also achieved a clinically meaningful reduction in pain of 30 percent or greater after three months compared with those on placebo.

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

Sharon Waldrop, a person with lived experience and founder of the Fibromyalgia Association, stated, “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. 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.”

Philip Mease, M.D., Director of Rheumatology Research at the Providence Swedish Medical Center and Clinical Professor at the University of Washington School of Medicine, said, “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. Tonmya is a novel treatment approach that targets nonrestorative sleep that is characteristic of fibromyalgia and can impact core symptoms, specifically pain.”

Andrea L. Chadwick, M.D., MSc, FASA, Anesthesiology, Pain, and Perioperative Medicine at The University of Kansas Health System, explained, “I know firsthand how the chronic pain of fibromyalgia significantly disrupts my patients’ lives. Treatments that are processed through the liver can result in metabolites that could affect a medicine’s efficacy and safety over time. Tonmya is administered sublingually which is designed to reduce pain quickly and durably with a tolerable safety profile.”

Safety data from three Phase 3 clinical trials involving more than 1,400 patients showed that Tonmya was generally well tolerated. The most common side effects, reported in at least 2 percent of patients and more frequently than placebo, included numbness or tingling in the mouth, oral discomfort, altered taste, drowsiness, fatigue, dry mouth, mouth pain, and canker sores.

The most recent Phase 3 trial, known as RESILIENT, was published in the journal Pain Medicine. It provided comprehensive data on both primary and secondary endpoints, assessing pain relief, patients’ overall impression of improvement, symptom management, functional outcomes, sleep disturbances, and fatigue. Tonix acknowledged the contributions of the patients, investigators, and regulatory authorities involved in the development and approval process. The company confirmed that Tonmya will be available to adult patients in the United States with fibromyalgia starting in the fourth quarter of this year.