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Home » Drug Information » FDA Approved Drugs » 2009
Medical Areas: Immunology | Neurology

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Qutenza (capsaicin)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: NeurogesX
Approval Status: Approved November 2009
Treatment Area: neuropathic pain associated with postherpetic neuralgia

General Information

Qutenza (capsaicin) 8% is a transdermal patch containing capsaicin in a localized dermal delivery system. The capsaicin in Qutenza is a synthetic equivalent of the naturally occurring compound found in chili peppers. Qutenza works by targeting certain pain nerves in the area of skin where pain is being experienced. It selectively binds to a protein known as TRPV1 that resides on the membranes of pain and heat sensing neurons.

Qutenza is specifically indicated for the management of neuropathic pain associated with postherpetic neuralgia.

Qutenza is supplied as an 8% formulation patch for transdermal administration. The recommended initial dose is a single, 60-minute application of up to four patches. Treatment with Qutenza may be repeated every three months or as warranted by the return of pain (not more frequently than every three months). Qutenza should only be administered by a physician or health care professional under the close supervision of a physician.

Clinical Results

FDA Approval
The FDA approval of Qutenza was based on two 12-week, double-blind, randomized, dose-controlled, multicenter studies. These studies enrolled patients with postherpetic neuralgia (PHN) persisting for at least 6 months following healing of herpes zoster rash and a baseline score of 3-9 on an I I-point Numerical Pain Rating Scale (NPRS): 0 (no pain) to 10 (worst possible pain). Qutenza and a control patch were each applied as a single 60-minute application. The patients who entered the study on stable doses of pain-control medications were required to keep dosing stable throughout the duration of the study. Prior to study patch application a topical anesthetic was applied to the treatment area for 60 minutes.

Study One
The Qutenza group demonstrated a greater reduction in pain compared to the control group during the primary assessment at Week 8. The percent change in average pain from baseline to Week 8 was - 18% for the low-dose control and -29% for Qutenza.

Study Two
The Qutenza group demonstrated a greater reduction in pain compared to the Control group during the primary assessment at Week 8. The percent change in average pain from baseline to Week 8 was -26% for the low-dose control and -33% for Qutenza.

Side Effects

Adverse events associated with the use of Qutenza may include, but are not limited to, the following:

  • Application site erythema
  • Application site pain
  • Application site pruritus
  • Application site papules

Mechanism of Action

Qutenza (capsaicin) 8% is a transdermal patch containing capsaicin in a localized dermal delivery system. The capsaicin in Qutenza is a synthetic equivalent of the naturally occurring compound found in chili peppers. Capsaicin is an agonist for the transient receptor potential vanilloid I receptor (TRPVI), which is an ion channel-receptor complex expressed on nociceptive nerve fibers in the skin. Topical administration of capsaicin causes an initial enhanced stimulation of the TRPVI -expressing cutaneous nociceptors that may be associated with painful sensations. This is followed by pain relief thought to be mediated by a reduction in TRPV 1expressing nociceptive nerve endings.

Literature References

Babbar S, Marier JF, Mouksassi MS, Beliveau M, Vanhove GF, Chanda S, Bley K Pharmacokinetic analysis of capsaicin after topical administration of a high-concentration capsaicin patch to patients with peripheral neuropathic pain. Therapeutic Drug Monitoring 2009 Aug;31(4):502-10.

Backonja M, Wallace MS, Blonsky ER, Cutler BJ, Malan P Jr, Rauck R, Tobias J; NGX-4010 C116 Study Group NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. Lancet Neurology 2008 Dec;7(12):1106-12

Watson CP, Tyler KL, Bickers DR, Millikan LE, Smith S, Coleman E A randomized vehicle-controlled trial of topical capsaicin in the treatment of postherpetic neuralgia. Clinical Therapeutics 1993 May-Jun;15(3):510-26

Additional Information

For additional information regarding Qutenza or postherpetic neuralgia, please visit the Qutenza web page.