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Skelaxin (METAXALONE)
Skelaxin works by inhibiting the action of neurotransmitters that stimulate muscle contraction.
Skelaxin (METAXALONE) is a small molecule muscle relaxant developed by King Pharms, approved by the FDA in 1962 for the treatment of spasticity. As a muscle relaxant, it works by reducing muscle tone and spasms. Skelaxin is available as a generic medication, with multiple manufacturers, and is used to alleviate symptoms of spasticity. Key safety considerations include potential drowsiness, dizziness, and liver function monitoring. Commercially, Skelaxin is off-patent, allowing for generic competition.
At a glance
| Generic name | METAXALONE |
|---|---|
| Sponsor | Pfizer |
| Drug class | Muscle Relaxant [EPC] |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1962 |
Mechanism of action
Mechanism of Action:The mechanism of action of metaxalone in humans has not been established, but may be due to general central nervous system (CNS) depression. Metaxalone has no direct action on the contractile mechanism of striated muscle, the motor end plate, or the nerve fiber.
Approved indications
- Spasticity
Common side effects
- drowsiness
- dizziness
- headache
- nervousness or irritability
- nausea
- vomiting
- gastrointestinal upset
- hypersensitivity reaction
- rash with or without pruritus
- leukopenia
- hemolytic anemia
- jaundice
Key clinical trials
- Assess the Effect of Metaxalone 640 mg (M640) Compared to Tizanidine 8 mg on Truck Driving Ability and Cognition (PHASE4)
- Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions. (PHASE4)
- Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg (PHASE4)
- Pain Control After Lumbar Spine Fusion (PHASE4)
- Opioid Free vs. Standard Perioperative Pain Regimen for Anterior Cervical Discectomy and Fusion (ACDF) Surgery (PHASE4)
- Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain (PHASE4)
- The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 11918559 | 2039-07-29 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |