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Soma (CARISOPRODOL)
Carisoprodol's mechanism for relieving acute musculoskeletal pain is unclear, but it involves altered interneuronal activity in the spinal cord and brain.
Soma (Carisoprodol) is a small molecule muscle relaxant originally developed by Meda Pharms and currently owned by Mylan Specialty LP. It was FDA approved in 1959 for the treatment of backache, muscle spasm with pain, and spasticity. As an off-patent medication, Soma is available as a generic from 22 manufacturers. Key safety considerations include its potential for dependence and abuse. Commercially, Soma is widely available as a generic.
At a glance
| Generic name | CARISOPRODOL |
|---|---|
| Sponsor | Mylan Speciality Lp |
| Drug class | Muscle Relaxant [EPC] |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1959 |
Mechanism of action
The exact way carisoprodol works to relieve pain is not fully understood. However, studies in animals suggest that its muscle-relaxing effects are linked to changes in nerve cell activity in the spinal cord and a part of the brain called the descending reticular formation.
Approved indications
- Backache
- Muscle Spasm with Pain
- Spasticity
Common side effects
- Dizziness
- Drowsiness
- Nausea
- Vomiting
- Epigastric discomfort
- Tachycardia
- Postural hypotension
- Facial flushing
- Vertigo
- Ataxia
- Tremor
- Agitation
Drug interactions
- sodium oxybate
Key clinical trials
- Security and Efficacy of Dorilax® (Fixed Association of Paracetamol 350 mg, Carisoprodol 150 mg and Caffeine 50 mg) Plus Thermal Band Compared to Placebo Plus Thermal Band in the Treatment of Acute Low Back Pain. (PHASE3)
- Controlled Substance Treatment Agreements in an Internal Medicine Residents' Clinic (NA)
- Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back (PHASE3)
- A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol (PHASE3)
- A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back (PHASE3)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Soma CI brief — competitive landscape report
- Soma updates RSS · CI watch RSS
- Mylan Speciality Lp portfolio CI