NDASUBLINGUALTABLET
Approved
Aug 2025
Lifecycle
Launch
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 1h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TONMYA is a sublingual tablet formulation of cyclobenzaprine hydrochloride, a centrally-acting skeletal muscle relaxant that relieves muscle spasm of local origin by reducing tonic somatic motor activity at the brainstem level. It is indicated for acute musculoskeletal conditions and does not act at the neuromuscular junction or directly on skeletal muscle. The drug exhibits tricyclic antidepressant-like pharmacology including anticholinergic effects and norepinephrine potentiation.
Launch7.7 years to LOE
Early-stage launch product with 17 linked positions across commercial, R&D, and regulatory functions; team building and market penetration phase underway.
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.