QUTENZA
QUTENZA is a topical TRPV1 channel agonist indicated for the treatment of neuropathic pain in adult patients. It is specifically approved for managing pain associated with postherpetic neuralgia and diabetic peripheral neuropathy of the feet. The medication provides a localized therapeutic approach for patients suffering from these chronic nerve-related conditions.
How QUTENZA Works
Capsaicin acts as an agonist for the transient receptor potential vanilloid 1 (TRPV1) receptor, an ion channel-receptor complex located on pain-sensing nerve fibers in the skin. Topical administration initially stimulates these cutaneous nociceptors, which may be associated with painful sensations. This process is followed by pain relief mediated by a reduction in TRPV1-expressing nerve endings, which lasts until the nerve fibers eventually reinnervate the treated area.
Details
- Status
- Prescription
- First Approved
- 2009-11-16
- Routes
- TOPICAL
- Dosage Forms
- PATCH
QUTENZA Approval History
What QUTENZA Treats
3 indicationsQUTENZA is approved for 3 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Neuropathic Pain
- Postherpetic Neuralgia
- Diabetic Peripheral Neuropathy
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Active Pipeline
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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.
QUTENZA FDA Label Details
ProIndications & Usage
FDA Label (PDF)QUTENZA is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and for neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet. QUTENZA is a TRPV1 channel agonist indicated for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.