NDASUBLINGUALTABLET
Approved
Aug 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
6/8 — Strong
TONMYA (cyclobenzaprine hydrochloride) by Tonix Pharmaceuticals is cyclobenzaprine hydrochloride relieves skeletal muscle spasm of local origin without interfering with muscle function. Approved for chronic migraine. First approved in 2025.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TONMYA is a sublingual tablet formulation of cyclobenzaprine hydrochloride approved in August 2025 for chronic migraine treatment. It works as a skeletal muscle relaxant acting primarily at the brainstem to reduce tonic motor activity through modulation of gamma and alpha motor systems. This is a novel indication repositioning a traditional muscle relaxant class into preventive migraine therapy.
Launch7.9 years to LOE
Early-stage launch from emerging sponsor (Tonix) in crowded migraine market; expects rapid team scaling for field presence and market education.
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…
Worked on TONMYA at Tonix Pharmaceuticals? Share your interview experience or compensation data (+7 days Pro)
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.