TONMYA (cyclobenzaprine hydrochloride)
Tonmya is a medication used to help adults who have fibromyalgia. It provides a therapeutic option for managing this condition in the adult population. This drug is specifically used for those diagnosed with fibromyalgia to help address their symptoms.
How TONMYA Works
While the exact way this drug treats fibromyalgia is not fully understood, it works by interacting with several different receptors in the body, such as serotonin and histamine receptors. It also shares characteristics with tricyclic antidepressants, including the ability to increase norepinephrine levels and produce sedative effects.
Details
- Status
- Prescription
- First Approved
- 2025-08-15
- Patent Cliff
- 2034
- Routes
- SUBLINGUAL
- Dosage Forms
- TABLET
TONMYA Approval History
What TONMYA Treats
1 indicationsTONMYA is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Fibromyalgia
TONMYA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to TONMYA
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01151787 | CEPH03242010 | Ph 3 | terminated | Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TONMYA FDA Label Details
Indications & Usage
TONMYA is indicated for the treatment of Fibromyalgia.
TONMYA Patents & Exclusivity
Patents (4 active)
Exclusivity
Pro Intelligence Preview
Deep insights for TONMYA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 4 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 3 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.