US EditionUSFDA Approves Tonix Pharma Tonmya for Fibromyalgia in Adults
Tonmya, a non-opioid analgesic approved by the FDA, significantly reduced fibromyalgia pain by about 30% in clinical trials involving over 1,000 patients.
- On August 15th, the US Food and Drug Administration approved Tonmya , a non-opioid bedtime treatment for adults with fibromyalgia in the United States.
- A long approval drought left clinicians with limited options, as no new FDA-approved fibromyalgia therapy had been approved in over 15 years while the condition affects ten million adults in the US, with women making up around 80% of sufferers.
- In clinical trials, RELIEF and RESILIENT of nearly 1,000 patients combined showed approximately 59.7% of Tonmya-treated patients reported treatment-emergent adverse events versus 46.3% with placebo, including oral hypoesthesia in 17.3% versus 0.4%.
- Tonmya will be available in the fourth quarter of 2025, with patents from the US Patent and Trademark Office ensuring market exclusivity until at least 2034.1.
- Following the approval, Tonmya targets nonrestorative sleep to ease symptoms, offering a first-in-class non-opioid sublingual analgesic option for 10 million patients with fibromyalgia.
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FDA approves first-in-class drug for fibromyalgia - Juta MedicalBrief
The FDA has approved cyclobenzaprine hydrochloride sublingual tablets (Tonmya, Tonix Pharmaceuticals), a first-in-class, non-opioid treatment for adults with fibromyalgia, a chronic pain syndrome that affects more than 10m Americans, around 80% of whom are women. Medscape reports that the medication, taken once-daily at bedtime, targets non-restorative sleep, a root cause of pain, fatigue and brain fog in fibromyalgia, and is the first new FDA-a…
Tonmya is FDA Approved to Treat Fibromyalgia: CEO Seth Lederman Talks - Health Rising
A Non-Opioid Drug for Fibromyalgia Soon to Hit the US Market For the first time in 15 years, a drug has been approved for fibromyalgia in the U.S. On August 15th, the FDA approved Tonmya for use in fibromyalgia (FM). It’s been a long wait – 15 years – since the last drug was approved for FM. I felt like pinching myself. Health Rising has been following the Tonmya (formerly TNX-102) saga for at least five years. Tonmya seemed as dead as a duck at…
TNX-102 SL Now Fourth FDA-Approved Treatment for Fibromyalgia
This approval brings the total to 4 of medications approved to treat fibromyalgia; in addition to cyclobenzaprine HCl sublingual tablets (TNX-102 SL; Tonmya; Tonix Pharmaceuticals), there are pregabalin (Lyrica; Viatris), duloxetine (Cymbalta; Eli Lilly), and milnacipran (Savella; AbbVie).
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