Qutenza^® (capsaicin) 8% patch

Proven Efficacy.

Qutenza^® has proven, long-lasting pain relief in two 12-week, pivotal postherpetic neuralgia trials.²

• The studies enrolled patients with PHN and a baseline score of 3 to 9 on an 11-point Numerical Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (worst possible pain).¹
• Approximately half of the patients in the studies were taking concomitant medications including anticonvulsants, non-SSRI antidepressants, or opioids at study entry.¹
• Qutenza^® and a low-dose control patch were administered as a single, 1-hour application.¹

A Single, 1-Hour, Localized Treatment Can Provide 3 Months of Relief From Pain Associated With PHN

Results from a 12-week, double-blind, randomized, dose-controlled, multicenter study of 402 postherpetic neuralgia patients. Individual patient results may vary.

Results from a 12-week, double-blind, randomized, dose-controlled, multicenter study of 416 postherpetic neuralgia patients. Individual patient results may vary.

Significant Number of Postherpetic Neuralgia Patients Experience Meaningful Reduction in Pain Severity

In the 2 pivotal postherpetic neuralgia trials, 44% and 47% of patients, respectively, had their pain reduced by 30% or more during the 12-week studies.²

Powerful Pain Reduction.¹ Long-Lasting Pain Relief.¹

• In the two 12-week, double-blind, randomized, dose-controlled, multicenter studies:
  • The Qutenza^® group demonstrated a greater reduction in pain compared to the low-dose control group during the primary assessment at week 8.¹
  • Approximately half of the patients in the studies were taking concomitant medications including anticonvulsants, non-SSRI antidepressants, or opioids at study entry.¹
  • Some patients experienced a decrease in pain as early as week 1, which persisted throughout the 12-week study period.¹
  • Patients who did not complete the study through the analysis week or who showed no improvement at that week were assigned 0% improvement.¹
  
• The percent change in average pain from baseline to week 8 was:
  • -29% (± 2%) for Qutenza^® vs -18% (± 2%) for low-dose control in Study 1¹
  • -33% (± 2%) for Qutenza^® vs -26% (± 2%) for low-dose control in Study 2¹

Safety Profile

Warnings and Precautions:

• Do not use near eyes or mucous membranes.¹
• Inhalation of airborne capsaicin can result in coughing or sneezing.¹
• If irritation of eyes or airway occurs, remove the affected individual from the vicinity of Qutenza^® and flush the mucous membranes or eyes with water.¹
• If skin not intended to be treated comes in contact with Qutenza^®, apply Cleansing Gel for at least 1 minute and wipe off with dry gauze and then wash the area with soap and water.¹
• Patients may experience substantial procedural (application-associated) pain. Prepare to treat pain during and following the application procedure.¹
• Transient increases in blood pressure (< 10 mm Hg on average) may occur.¹

Serious Adverse Reactions:

• Application-associated pain
  • Patients may experience substantial procedural pain.¹
  • Prepare to treat acute pain during and following the application procedure using local cooling (e.g., cold pack) and/or appropriate analgesic medication.¹
• Increase in blood pressure
  • Increases in blood pressure (average less than 10 mm Hg) occurred during or shortly after exposure to Qutenza^®.¹
  • Increases were unrelated to the pre-treatment blood pressure but were related to treatment-related increases in pain.¹
  • Monitor blood pressure periodically during the treatment and provide adequate support for treatment-related pain.¹
  • Patients with unstable or poorly controlled hypertension or a recent history of cardiovascular or cerebrovascular events may be at an increased risk of adverse cardiovascular effects. Consider these factors prior to initiating Qutenza^® treatment.¹

Most Common Side Effects Are Local, Transient, and Self-Limited¹

In controlled clinical trials:

• Only 1% of Qutenza^® patients discontinued clinical studies due to adverse events, comparable to control.¹
• 98% of patients completed ≥ 90% of the intended patch-application duration.¹

Low risk for systemic side effects

• Qutenza^® is non-narcotic and is unlikely to cause drowsiness or have drug-drug interactions. It can be used alone or with other pain medications.¹
• Systemic adverse reactions are unlikely because minimal capsaicin is absorbed into patients are unlikely to have measurable capsaicin in the bloodstream.¹
• No contraindications.¹