Following decades of limited treatment options, people living with fibromyalgia will soon have access to a novel therapy designed to tackle the condition’s most elusive symptom: Poor-quality sleep. The US Food and Drug Administration (FDA) has just approved Tonmya, a non-opioid, under-the-tongue bedtime treatment for fibromyalgia in adults, which is expected to be widely available within months. It’s the first drug approved for this complex and debilitating condition in more than 15 years.
Tonmya is a nightly cyclobenzaprine HCl sublingual tablet that's rapidly absorbed after placing it under the tongue, bypassing the digestive system for faster onset of action. In clinical trials, this quick delivery helped improve sleep quality and reduce next-day fibromyalgia pain – offering immediate relief as well as potentially longer-term symptom improvement.
The drug breaks ground as the first and only in a category of non-opioid analgesics to treat fibromyalgia.
“The FDA approval of Tonmya as a first-line treatment for fibromyalgia represents a landmark advancement for the millions of people in the US 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.”
According to the Centers for Disease Control and Prevention (CDC), fibromyalgia affects around 2% of the world's population, including at least four million adults in the US, up to three million in the UK and one million in Australia. It causes widespread pain throughout the body, as well as sleep problems, fatigue, cognitive issues and mental health problems. The cause of the condition is not known, but abnormal pain perception processing is the hallmark of it – and so far there's no cure, just pain management.
And fibromyalgia has long been misunderstood, poorly diagnosed – often dismissed as psychosomatic – and under-treated. Around 80% of sufferers are women.
“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 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.”
While FDA-approved medications like Lyrica (pregabalin), Cymbalta (duloxetine) and Savella (milnacipran HCI) help suffers manage their symptoms, they primarily target pain or mood issues, and often do little to improve non-restorative sleep – which exacerbates symptoms. This results in a feedback loop, where worse pain means poorer sleep, which in turn makes daytime symptoms much worse. By increasing restorative sleep, Tonmya may interrupt the pain-sleep-pain cycle at its root.
Importantly, Tonmya is non-opioid and non-sedating – two important factors considering that the chronic condition can impact people for years or even decades. Existing sedative medications can impair cognition and worsen "fibro fog" the next day. While they mask the pain, this new drug aims to modulate it, which could help regulate pain signals long-term. It also doesn't cause weight gain or gastrointestinal distress like oral medications such as pregabalin.
“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.”
Tonmya – which the FDA announced will be commercially available in the fourth quarter of 2025, is more than a milestone – it’s a long-overdue sign that fibromyalgia is finally being taken seriously, and provides sufferers with new hope. The release comes after two Phase III clinical trials that both delivered a statistically significant reduction in daily pain compared to a placebo. The most common side effect was mouth or tongue numbness, due to the drug's delivery method, which was temporary.
The drug is also currently in the trial stage for the treatment of post-traumatic stress disorder (PTSD), alcohol use disorder and Alzheimer's disease-triggered agitation.
“I know firsthand how the chronic pain of fibromyalgia significantly disrupts my patients’ lives,” said Andrea L. Chadwick, M.D., MSc, FASA, Anesthesiology, Pain, and Perioperative Medicine at The University of Kansas Health System. “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.”
Not surprisingly, market experts predict Tonmya could deliver its company more than US$800 million in annual sales within the decade.
“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, M.D., Director of Rheumatology Research at the Providence Swedish Medical Center and Clinical Professor at the University of Washington School of Medicine. “Tonmya is a novel treatment approach that targets non-restorative sleep that is characteristic of fibromyalgia and can impact core symptoms, specifically pain.”
The results of the Phase III studies were published in the journals Arthritis Care & Research and Pain Medicine.
Source: Tonix Pharmaceuticals
