Not an actual patient.
Efficacy Behind QUTENZA1
In a clinical study of adult patients, QUTENZA delivered statistically and clinically significant pain relief associated with painful diabetic peripheral neuropathy (DPN) of the feet, and a faster time to treatment was achieved with QUTENZA vs placebo in adult patients after a single application.
QUTENZA provided sustained relief of pain after a single treatment from baseline to Week 12 (vs placebo)1,2
Average change in pain from baseline to Week 12: -30% (±3%) for QUTENZA vs -22% (±3%) for placebo.
Results from a 12-week, double-blind, randomized, placebo-controlled, multicenter study of 369 patients with painful DPN.
The least-squares mean change was -1.92 on the 11-point numeric pain rating scale (NPRS) for QUTENZA, vs -1.37 for placebo, a least-squares mean difference of -0.56 (95% CI -0.98, -0.14).
Efficacy was demonstrated regardless of concomitant use of other medications
Approximately half (47.2%) of the patients in the studies were taking concomitant medications, including anticonvulsants, non-selective serotonin reuptake inhibitor (SSRI) antidepressants, or opioids, at study entry and were required to keep dosing stable throughout the duration of the study.2
In a post-hoc analysis, when used alone, QUTENZA reduced the NPRS score over 12 weeks of treatment1,3
Post-hoc analysis of efficacy among participants NOT taking concomitant systemic medications at the start of, and during, the 12 weeks of the study.*
Average change from baseline to Weeks 2-12 was -31% for QUTENZA vs -20% for placebo; the least-squares mean difference (QUTENZA – placebo) was -9.5%.†
Limitation: This is a post-hoc analysis which is considered exploratory; therefore, the results require cautious interpretation and could represent chance findings.
Secondary endpoint: Proportion of patients achieving ≥30% reduction in pain from baseline1
40.9% responders with QUTENZA vs 31.7% responders with placebo at Weeks 2 through 12; p=0.050. “Responder” defined as one who experienced a ≥30% NPRS score reduction from Weeks 2 through 12.
Secondary endpoint: After a single application, the average time to treatment response for patients with QUTENZA was 19 days vs 72 days for those patients who received placebo1
Kaplan-Meier curves for median time to treatment response (30% reduction in average daily pain; safety analysis set). 50% of patients achieved at least a 30% reduction in average daily pain score.
INDICATION
QUTENZA® (capsaicin) 8% topical system is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) or associated with diabetic peripheral neuropathy (DPN) of the feet.
IMPORTANT SAFETY INFORMATION
Do not dispense QUTENZA to patients for self‑administration or handling. Use only on dry, unbroken skin. Only physicians or healthcare professionals are to administer and handle QUTENZA, following the procedures in the label.
Warnings and Precautions
- Severe Irritation: Whether applied directly or transferred accidentally from other surfaces, capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin to the healthcare professional, patients, and others. Do not use near eyes or mucous membranes, including face and scalp. Take protective measures, including wearing nitrile gloves and not touching items or surfaces that the patient may also touch. Flush irritated mucous membranes or eyes with water and provide supportive medical care for shortness of breath. Remove affected individuals from the vicinity of QUTENZA. Do not re‑expose affected individuals to QUTENZA if respiratory irritation worsens or does not resolve. If skin not intended to be treated comes into contact with QUTENZA, apply Cleansing Gel and then wipe off with dry gauze. Thoroughly clean all areas and items exposed to QUTENZA and dispose of properly. Because aerosolization of capsaicin can occur with rapid removal, administer QUTENZA in a well‑ventilated area, and remove gently and slowly, rolling the adhesive side inward.
- Application-Associated Pain: Patients may experience substantial procedural pain and burning upon application and following removal of QUTENZA. Prepare to treat acute pain during and following application with local cooling (e.g., ice pack) and/or appropriate analgesic medication.
- Increase in Blood Pressure: Transient increases in blood pressure may occur with QUTENZA treatment. Monitor blood pressure during and following treatment procedure and provide support for treatment‑related pain. 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.
- Sensory Function: Reductions in sensory function (generally minor and temporary) have been reported following administration of QUTENZA. All patients with sensory deficits should be assessed for signs of sensory deterioration or loss prior to each application of QUTENZA. If sensory loss occurs, treatment should be reconsidered.
Adverse Reactions
The most common adverse reactions (≥5% and > control group) in all controlled clinical trials are application site erythema, application site pain, and application site pruritus.
To report SUSPECTED ADVERSE REACTIONS, contact Averitas Pharma, Inc. at 1‑877‑900‑6479 or FDA at 1‑800‑FDA‑1088 or
Please see full Prescribing Information.
INDICATION
QUTENZA® (capsaicin) 8% topical system is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) or associated with diabetic peripheral neuropathy (DPN) of the feet.
IMPORTANT SAFETY INFORMATION
Do not dispense QUTENZA to patients for self‑administration or handling. Use only on dry, unbroken skin. Only physicians or healthcare professionals are to administer and handle QUTENZA, following the procedures in the label.
Warnings and Precautions
- Severe Irritation: Whether applied directly or transferred accidentally from other surfaces, capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin to the healthcare professional, patients, and others. Do not use near eyes or mucous membranes, including face and scalp. Take protective measures, including wearing nitrile gloves and not touching items or surfaces that the patient may also touch. Flush irritated mucous membranes or eyes with water and provide supportive medical care for shortness of breath. Remove affected individuals from the vicinity of QUTENZA. Do not re‑expose affected individuals to QUTENZA if respiratory irritation worsens or does not resolve. If skin not intended to be treated comes into contact with QUTENZA, apply Cleansing Gel and then wipe off with dry gauze. Thoroughly clean all areas and items exposed to QUTENZA and dispose of properly. Because aerosolization of capsaicin can occur with rapid removal, administer QUTENZA in a well‑ventilated area, and remove gently and slowly, rolling the adhesive side inward.
- Application-Associated Pain: Patients may experience substantial procedural pain and burning upon application and following removal of QUTENZA. Prepare to treat acute pain during and following application with local cooling (e.g., ice pack) and/or appropriate analgesic medication.
- Increase in Blood Pressure: Transient increases in blood pressure may occur with QUTENZA treatment. Monitor blood pressure during and following treatment procedure and provide support for treatment‑related pain. 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.
- Sensory Function: Reductions in sensory function (generally minor and temporary) have been reported following administration of QUTENZA. All patients with sensory deficits should be assessed for signs of sensory deterioration or loss prior to each application of QUTENZA. If sensory loss occurs, treatment should be reconsidered.
Adverse Reactions
The most common adverse reactions (≥5% and > control group) in all controlled clinical trials are application site erythema, application site pain, and application site pruritus.
To report SUSPECTED ADVERSE REACTIONS, contact Averitas Pharma, Inc. at 1‑877‑900‑6479 or FDA at 1‑800‑FDA‑1088 or
Please see full Prescribing Information.