Metaxalone
Metaxalone (metaxalone) is a small molecule pharmaceutical. Metaxalone was first approved as Skelaxin on 1982-01-01. It is used to treat muscle cramp, muscle rigidity, muscle spasticity, myositis, and pain amongst others in the USA.
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Commercial
Trade Name
FDA
EMA
Metaxalone (discontinued: Metaxalone, Skelaxin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Metaxalone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SKELAXIN | King Pharmaceuticals | N-013217 DISCN | 1982-01-01 | 2 products, RLD |
| METAXALONE | Primus Pharmaceuticals | N-022503 DISCN | 2015-06-01 | 1 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| metaxal | ANDA | 2025-01-31 |
| metaxalone | ANDA | 2025-08-05 |
| skelaxin | ANDA | 2021-03-09 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myositis | EFO_0000783 | D009220 | G72.49 |
| pain | EFO_0003843 | D010146 | R52 |
| muscle spasticity | — | D009128 | — |
| muscle cramp | — | D009120 | — |
| spasm | — | D013035 | M62.83 |
| muscle rigidity | — | D009127 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Metaxalone, Skelaxin, King Pharms | |||
| 7122566 | 2026-02-06 | U-915 | |
ATC Codes
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HCPCS
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Clinical
Clinical Trials
8 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | — | — | — | 2 | — | 2 |
| Low back pain | D017116 | — | M54.5 | — | — | — | 1 | — | 1 |
| Back pain | D001416 | — | M54 | — | — | — | 1 | — | 1 |
| Postoperative complications | D011183 | — | — | — | — | — | 1 | — | 1 |
| Spinal diseases | D013122 | — | M45-M49 | — | — | — | 1 | — | 1 |
| Pathologic constriction | D003251 | — | — | — | — | — | 1 | — | 1 |
| Spinal stenosis | D013130 | EFO_0007490 | M48.0 | — | — | — | 1 | — | 1 |
| Sciatica | D012585 | — | M54.3 | — | — | — | 1 | — | 1 |
| Spinal fusion | D013123 | — | — | — | — | — | 1 | — | 1 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | — | — | 1 | — | 1 |
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Indications Phases 3
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Indications Phases 2
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Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | — | — | 1 | 1 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | — | — | 1 | 1 |
| Endoscopy | D004724 | — | — | — | — | — | — | 1 | 1 |
| Colonic diseases | D003108 | — | — | — | — | — | — | 1 | 1 |
| Functional colonic diseases | D003109 | — | — | — | — | — | — | 1 | 1 |
| Prone position | D016684 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Metaxalone |
| INN | metaxalone |
| Description | Metaxalone is an aromatic ether. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1cc(C)cc(OCC2CNC(=O)O2)c1 |
Identifiers
| PDB | — |
| CAS-ID | 1665-48-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1079604 |
| ChEBI ID | 6797 |
| PubChem CID | 15459 |
| DrugBank | DB00660 |
| UNII ID | 1NMA9J598Y (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Skelaxin – Amneal Pharmaceuticals
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Skelaxin – Elan Corporation
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Skelaxin – Pfizer
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Estimated US medical usage
Metaxalone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 533 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,780 adverse events reported
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