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Tonmya – First New Fibromyalgia Drug in 16 Years, But Questions Remain

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Category: Medical Info and Drug Trials
Published on Sunday, 17 August 2025 14:29
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Tonix Pharmaceuticals has gained FDA approval for Tonmya, the first new fibromyalgia medicine since 2007. Taken under the tongue at bedtime, Tonmya (cyclobenzaprine HCl) is designed to improve non‑restorative sleep which is a core feature of fibromyalgia rather than directly targeting pain.
 
In two Phase 3 trials involving nearly 1,000 patients, it was reported that it modestly outperformed placebo in reducing daily pain after 14 weeks, with more people achieving at least a 30% improvement. Its sublingual delivery may offer faster; more consistent absorption compared with older treatments processed through the liver. Side effects were reported as tolerable within the trials.
 
However, real‑world effectiveness and durability are still unproven. Cyclobenzaprine, the base molecule, has been tried before and shown benefits that faded over time. The FDA approval is based on relatively short studies, so it is unclear how well the drug will work beyond a few months and what it will cost. Experts also note fibromyalgia’s complexity means no single drug helps everyone.
 
While Tonmya offers a welcome new option after a long treatment drought, patients and clinicians may wish to view it as one tool among many, best combined with lifestyle, sleep, and other self-management approaches.

Additionally approval by the FDA in America does not mean it will be approved within the UK. It will require to pass regulatory approval once more before we see it being prescribed by the NHS. 

The active ingredient Cyclobenzaprine was previously available in the UK but is not currently licensed. It has been used previously for fibromyalgia patients. 
 
 
 

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