FDA approves Tonmya for fibromyalgia treatment

Key takeaways:

The approval is supported by data from multiple phase 3 clinical trials evaluating Tonmya’s safety and efficacy.

This is the first FDA-approved therapy for fibromyalgia in more than 15 years.

Editor’s note: This is a developing news story. Please check back soon for updates.

The FDA approved Tonmya, a first-in-class, non-opioid, once-daily bedtime analgesic, for the treatment of fibromyalgia in adult patients, according to a press release from Tonix Pharmaceuticals.

Tonmya is the first FDA-approved therapy for fibromyalgia in more than 15 years.

The approval is supported by results from two double-blind, randomized, placebo-controlled, phase 3 clinical trials that included nearly 1,000 patients. Tonmya (cyclobenzaprine HCl sublingual tablets) achieved the primary stu