METAXALONE
Metaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.
Details
- Status
- Prescription
- First Approved
- 2010-03-31
- Patent Cliff
- 2043
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
METAXALONE Approval History
What METAXALONE Treats
9 FDA approvalsOriginally approved for its first indication in 2010 . Covers 9 distinct patient populations.
- Other (9)
Other
(9 approvals)- • Approved indication (Mar 2010)Letter
- • Approved indication (Jun 2013)
- • Approved indication (Feb 2015)Letter
- • Approved indication (Jun 2015)Label Letter
- • Approved indication (Nov 2016)
- • Approved indication (Jun 2017)
- • Approved indication (Aug 2017)
- • Approved indication (Sep 2018)
- • Approved indication (Oct 2020)
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03068897 results posted | 2017-7566 | Ph 4 | completed | Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain |
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.
METAXALONE FDA Label Details
Indications & Usage
FDA Label (PDF)Metaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.
METAXALONE Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for METAXALONE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2043
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • 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.