US EditionUSFDA Approves Tonix Pharma Tonmya for Fibromyalgia in Adults
Tonmya, a non-opioid analgesic taken once daily at bedtime, significantly reduces fibromyalgia pain and targets poor-quality sleep, offering new relief after 15 years without novel treatments.
- The FDA approved Tonmya, Tonix Pharmaceuticals' new treatment, as a first-in-class, nonopioid fibromyalgia therapy expected in the fourth quarter of 2025.
- Following decades of limited options, fibromyalgia causes widespread pain, sleep disturbance, fatigue and cognitive issues, and Tonmya targets nonrestorative sleep linked to these core symptoms, addressing a need unmet for over 15 years.
- In two Phase III trials, the RELIEF trial and RESILIENT trial demonstrated significant daily pain reductions at 14 weeks, with RESILIENT results published on July 8 in Pain Medicine.
- About 59.7% of Tonmya-treated patients experienced adverse events versus 46.3% of placebo-treated patients, with oral hypoesthesia among the most common, and trials reported no serious side effects.
- Approval positions Tonmya as the fourth FDA‑approved fibromyalgia treatment, joining pregabalin , duloxetine and milnacipran , with U.S. Patent and Trademark Office grants securing market exclusivity until at least 2034.
11 Articles
11 Articles
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).
Coverage Details
Bias Distribution
- 100% of the sources are Center
Factuality
To view factuality data please Upgrade to Premium
