Tonix launches its new fibromyalgia drug in US

 Following its FDA approval in the summer, Tonix Pharma's fibromyalgia therapy Tonmya has been launched onto the market in the US, becoming the first new drug for the painful condition in more than 16 years.

Tonmya (cyclobenzaprine HCl) is a new 5.6 mg sublingual (under-the-tongue) formulation of a well-established tricyclic muscle relaxant drug, and has been introduced with a wholesale acquisition cost of $1,860 per month (60 tablets), which will fall to $930 (30 tablets) for older patients and those with mild liver impairment.

Fibromyalgia is a common condition causing chronic pain, fatigue, poor sleep, and cognitive dysfunction that is estimated to affect more than 10 million people in the US, with women accounting for around 80% of all cases.

Tonmya – which uses a lower dose than other oral cyclobenzaprine formulations and is the first drug in the class to be approved for fibromyalgia – is designed to be taken at bedtime to reduce pain and aid sleep.

It uses a lower dose of cyclobenzaprine than the pill formulations used to aid sleep and as a muscle relaxant. The lower dose, combined with the under-the-tongue delivery that bypasses what's known as first-pass metabolism in the liver, reduces the risk of side effects.

Tonix's marketing application to the FDA was based on two late-stage studies, in which the drug significantly reduced daily pain compared to placebo at 14 weeks, alongside improvements in patient-reported symptoms, sleep disturbance, and fatigue.

"The availability of Tonmya is a momentous day for Tonix, providing […] people living with fibromyalgia a novel treatment that has been shown to address the debilitating, core symptom of this disease, widespread pain," said the company's chief executive, Seth Lederman.

"After more than 15 years without innovation for this disease, we are honoured to bring this new treatment option to patients in partnership with the full fibromyalgia community, including researchers, patients, and investigators," he added.

Tonmya joins a number of already-available treatment options for fibromyalgia, including Pfizer's Lyrica (pregabalin), Eli Lilly's Cymbalta (duloxetine), and AbbVie's Savella (milnacipran), which are all also available as lower-cost generics in the US.

That means Tonmya is entering a market at a premium to what is currently available, raising questions about its market potential, but one analyst cited by Reuters has suggested the drug could eventually reach peak US sales of $800 million a year.

Tonix prepared for the launch of Tonmya by acquiring two sumatriptan-based drugs (Zembrace SymTouch and Tosymra) for migraine, allowing it to build up a commercial team. It will self-market the new drug in the US. The two products brought in just over $3 million in the third quarter.

Tonix is also studying a 5.6 mg sublingual formulation of cyclobenzaprine, which is due to start a phase 2 trial in major depressive disorder (MDD) in mid-2026, targeting the disturbed sleep of depression.

https://pharmaphorum.com/news/tonix-launches-its-new-fibromyalgia-drug-us