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Qutenza (CAPSAICIN)
Qutenza is a capsaicin-based small molecule that targets the transient receptor potential cation channel subfamily V member 1. It is FDA-approved for treating various types of pain, including arthritic pain, backache, neuralgia, postherpetic neuralgia, and sprains and strains. Qutenza is owned by Averitas, a company that acquired the rights from ACORDA, the original developer. The commercial status of Qutenza is patented, with no generic manufacturers available. Key safety considerations include potential skin irritation and allergic reactions.
At a glance
| Generic name | CAPSAICIN |
|---|---|
| Sponsor | Averitas |
| Drug class | capsaicin |
| Target | Transient receptor potential cation channel subfamily V member 1 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2009 |
Approved indications
- Arthritic Pain
- Backache
- Neuralgia
- Postherpetic neuralgia
- Sprains and Strains
Common side effects
- Application site erythema
- Application site pain
- Application site pruritus
- Application site papules
- Nasopharyngitis
- Application site edema
- Nausea
- Sinusitis
- Vomiting
- Bronchitis
- Application site swelling
- Application site dryness
Serious adverse events
- Deep partial-thickness (second-degree) burns
- Full-thickness (third-degree) burns
- Scarring
- Accidental exposure with eye pain
- Accidental exposure with cough
Key clinical trials
- Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome (PHASE2)
- Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain (PHASE1,PHASE2)
- The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster (NA)
- Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer (PHASE1)
- Qutenza 8% Capsaicin Topical System for the Treatment of Neuropathic Axial Lower Back Pain and Lumbosacral Radiculopathy
- Alcohol Neurolysis and Capsaicin for Postamputation Pain (PAP) (NA)
- Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia. (PHASE3)
- Pain Biomarker Study (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Qutenza CI brief — competitive landscape report
- Qutenza updates RSS · CI watch RSS
- Averitas portfolio CI