Study Highlights Pharmacokinetic Advantages of TONMYA for Fibromyalgia Treatment

Study Highlights Pharmacokinetic Advantages of TONMYA for Fibromyalgia Treatment

By, Admin 8 March 2026

Tonix Pharmaceuticals Holding Corp. has published new pharmacokinetic research supporting the design of TONMYA, its FDA-approved treatment for Fibromyalgia.

The study, published in the peer-reviewed journal Clinical Pharmacology in Drug Development, evaluates the pharmacokinetic profile of TNX-102 SL, the investigational name for TONMYA’s sublingual cyclobenzaprine formulation.

Importantly, the therapy received approval from the U.S. Food and Drug Administration on August 15, 2025, marking the first new prescription medicine approved for fibromyalgia in more than 15 years.

Why the Sublingual Formulation Matters?

Traditional oral formulations of Cyclobenzaprine are swallowed and undergo first-pass metabolism in the liver. This process generates high levels of the long-lasting metabolite norcyclobenzaprine, which may reduce treatment durability and increase side effects.

The sublingual design of TONMYA addresses this limitation.

Key formulation advantages include:

  • Rapid transmucosal absorption under the tongue
  • Bypassing first-pass hepatic metabolism
  • Lower exposure to the metabolite norcyclobenzaprine
  • Higher exposure to the active parent drug during sleep

According to Seth Lederman, CEO of Tonix Pharmaceuticals Holding Corp., a proprietary basifying agent in the formulation enables effective transmucosal delivery—something that earlier liquid formulations failed to achieve.

Key Findings from the Phase 1 Studies

The publication summarizes results from two randomized, open-label Phase 1 studies conducted in healthy volunteers.

Study 1: Comparing Sublingual vs Oral Cyclobenzaprine

The first study evaluated three sublingual formulations of cyclobenzaprine HCl 2.8 mg against an oral 5 mg immediate-release tablet.

Major findings:

  • Sublingual formulations showed rapid absorption
  • Relative bioavailability was 154% higher than oral cyclobenzaprine
  • Absorption lag time was ~3 minutes vs ~37 minutes for oral dosing
  • Early drug exposure (first hour AUC) was 783% higher

Among the formulations tested, the potassium phosphate dibasic formulation—later designated TNX-102 SL, demonstrated the most favorable pharmacokinetic profile and was selected for further development.

Study 2: Dose and Food Effect Evaluation

The second study evaluated TNX-102 SL at 2.8 mg and 5.6 mg.

Key observations:

  • The drug showed dose proportionality between both strengths
  • No food effect was observed, even with high-fat meals
  • The metabolite norcyclobenzaprine showed an elimination half-life of approximately 60 hours

Researchers believe reduced exposure to this metabolite contributes to the improved durability and tolerability observed in later Phase 3 trials.

Safety Profile

Across both Phase 1 studies, sublingual cyclobenzaprine HCl was generally well tolerated.

Key safety findings:

  • No serious adverse events reported
  • All treatment-emergent adverse events were mild or moderate
  • Most common events included:
    • Oral hypoesthesia
    • Abnormal taste

No clinically meaningful changes were observed in laboratory tests, vital signs, or ECG results.

Understanding Fibromyalgia

Fibromyalgia is a chronic pain disorder linked to amplified pain signaling within the central nervous system.

The condition affects an estimated 6–12 million adults in the United States, with approximately 90% of patients being women.

Common symptoms include:

  • Chronic widespread pain
  • Non-restorative sleep
  • Fatigue
  • Morning stiffness
  • Cognitive dysfunction (“fibro fog”)
  • Anxiety and depression

Many patients report significant impairment in daily activities and quality of life, and dissatisfaction with currently available treatments.

TONMYA’s Market Exclusivity

The proprietary formulation behind TONMYA is protected by multiple patents issued by the United States Patent and Trademark Office.

These include technologies such as:

  • Protectic™ protective eutectic system
  • Angstro-Technology™ formulation

Together, the patents are expected to provide U.S. market exclusivity until approximately 2034–2035.

Expanding the Pipeline

Beyond fibromyalgia, Tonix Pharmaceuticals Holding Corp. is evaluating TNX-102 SL in additional indications.

Current development programs include:

  • Major Depressive Disorder
  • Acute Stress Disorder

The company also maintains a broader pipeline targeting central nervous system and immunology disorders, reflecting its focus on diseases with significant unmet medical need.

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