Tonix Wins FDA Approval for Tonmya™, the First New Fibromyalgia Drug in 15 Years

Tonix Wins FDA Approval for Tonmya™, the First New Fibromyalgia Drug in 15 Years

By, Admin 18 August 2025

Tonix Pharmaceuticals has secured FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets) as a treatment for fibromyalgia in adults.

This is the first new FDA-approved therapy for fibromyalgia in more than 15 years — a major development for patients facing chronic pain, fatigue, and poor sleep.

Understanding Fibromyalgia

  • Prevalence: Affects an estimated 10 million adults in the US, most of them women.
  • Symptoms: Widespread pain, sleep disturbances, fatigue, stiffness, cognitive difficulties, and mood issues.
  • Impact: Leads to reduced quality of life and higher healthcare costs compared to the general population.
  • Cause: Thought to stem from increased central nervous system sensitivity.

What Makes Tonmya Different

  • Formulation: A sublingual version of cyclobenzaprine hydrochloride (previously studied as TNX-102 SL).
  • Rapid Absorption: Dissolves under the tongue for faster delivery into the bloodstream.
  • Fewer Side Effects: Designed to reduce production of a long-lasting metabolite linked with adverse events.
  • Dosing: Once-daily, non-opioid, taken at bedtime.

Tonix holds patents protecting Tonmya in the US until at least 2034, with pending applications that could extend exclusivity through 2044.

The Clinical Evidence

Approval was based on two Phase 3 trials with almost 1,000 patients.

  • Primary Outcome: Significant reduction in daily pain scores after 14 weeks compared to placebo.
  • Secondary Outcome: More patients on Tonmya achieved clinically meaningful improvements in pain.
  • Safety: Generally well tolerated across 1,400 patients studied in three trials.

Most common side effects included:

  • Mouth numbness or tingling
  • Altered taste
  • Drowsiness
  • Mouth discomfort or ulcers
  • Fatigue
  • Dry mouth

Market Impact

  • Unmet Need: Fibromyalgia patients have waited over a decade for a new therapy option.
  • Timing: Tonmya will be available in the US starting Q4 this year.
  • Positioning: As a non-opioid bedtime therapy, Tonmya offers an alternative approach in a field where treatment options remain limited.

Key Takeaway

Tonmya’s approval signals a long-awaited advancement in fibromyalgia care. With its unique sublingual delivery, pain-reducing efficacy, and non-opioid profile, it may reshape treatment strategies for millions of patients who have had few new options for over a decade.

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