Tonix Pharmaceuticals has received the US Food and Drug Administration’s (FDA) approval for Tonmya (cyclobenzaprine HCl sublingual tablets) to treat fibromyalgia in adults.
Tonmya, a tertiary amine tricyclic (TAT) and multifunctional agent, targets the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors.
Its patented sublingual tablet formulation offers rapid absorption and reduced production of norcyclobenzaprine, a long half-life active metabolite.
The FDA approved the drug as a non-opioid, once-daily bedtime analgesic option for the treatment of fibromyalgia in adults.
Fibromyalgia is a chronic pain disorder resulting from amplified sensory and pain signalling within the central nervous system that impacts daily life and quality of life.
Tonmya becomes the first new therapy approved by the FDA for fibromyalgia in over 15 years.
Tonix is planning to commercialise Tonmya in the US, starting in the fourth quarter of this year, offering a new option for adults suffering from fibromyalgia.
Tonix CEO Seth Lederman said: “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.
“At Tonix, we recognised 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 FDA approval of Tonmya is based on results from two double-blind, randomised, placebo-controlled Phase 3 clinical trials, RELIEF and RESILIENT.
The two-arm trials recruited 503 and 457 fibromyalgia adult patients in the US across 40 and 33 sites, respectively.
In the Phase 3 studies, Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks, thereby meeting the primary endpoint.
Also, a greater percentage of participants on Tonmya experienced a clinically meaningful improvement in pain after three months compared to those on placebo.
Tonmya was generally well tolerated, with common adverse events including oral hypoesthesia, oral discomfort, and somnolence.
