NDASUBLINGUALTABLET
Approved
Aug 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
5/8 — Partial
TONMYA (cyclobenzaprine hydrochloride) by Tonix Pharmaceuticals is cyclobenzaprine hydrochloride relieves skeletal muscle spasm of local origin without interfering with muscle function. First approved in 2025.
Drug data last refreshed 13h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TONMYA (cyclobenzaprine hydrochloride) is a centrally-acting skeletal muscle relaxant administered as a sublingual tablet that relieves muscle spasm of local origin by reducing tonic somatic motor activity at the brainstem level. The drug works by influencing both gamma and alpha motor systems without acting directly at the neuromuscular junction, making it ineffective for spasticity due to central nervous system disease. It is indicated for acute, localized skeletal muscle spasm.
Growth7.5 years to LOE
Recent 2025 approval positions TONMYA in early commercial expansion with growing market penetration; commercial team size expected to scale with adoption.
Mechanism of Action
Cyclobenzaprine hydrochloride relieves skeletal muscle spasm of local origin without interfering with muscle function. It is ineffective in muscle spasm due to central nervous system disease. Cyclobenzaprine reduced or abolished skeletal muscle hyperactivity in several animal models. Animal studies…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.