A Good Night’s Sleep: Tonix Phase 3 Results Offer Hope for Fibromyalgia Sufferers
Tonix Pharmaceuticals (Nasdaq: TNXP) is offering new hope to the 6 – 12 million Americans living with fibromyalgia with a potential new frontline treatment that has a completely new mechanism of action, relative to the three drugs that have been approved.
The three currently FDA-approved medicines for fibromyalgia are Cymbalta®, Lyric®, and Savella®, but their long-term use is often problematic due to side effects and dissatisfaction regarding their efficacy, reported by patients.
Tonix’s recent Phase 3 trial enrolled 457 fibromyalgia patients, and showed that the company’s candidate drug TNX-102 SL successfully improved sleep quality over placebo and achieved its primary endpoint of daily pain reduction.
Seth Lederman, MD, CEO of Tonix, said, “We believe the overall success of the trial and the strength of the effect on the primary endpoint are due to the kind of sleep fibromyalgia patients experience when they are taking TNX-102 SL therapy.”
Tonix plans to submit a New Drug Application (NDA) to the FDA under the 505(b)(2) regulatory approval pathway in the second half of 2024. The company said it is on track to supply the US market upon FDA approval.
A core pathology of the fibromyalgia syndrome prevents affected patients from being able to get restorative sleep. Traditional sleeping pills often impair the quality of sleep.
Tonix says that TNX-102 SL’s ability to facilitate restorative sleep is what drove the successful efficacy and tolerability outcomes in two successful Phase 3 trials in the management of fibromyalgia.
If approved by the FDA, TNX-102 SL would be the first new drug approved for fibromyalgia in more than a dozen years.
About Tonix Pharmaceuticals
Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system disorders.