Not an actual patient.
Efficacy Behind QUTENZA1
Study 1 and 2 primary endpoint: QUTENZA resulted in a significantly greater reduction in mean numeric pain rating scale (NPRS) scores from baseline to Week 8 compared to control in patients with postherpetic neuralgia (PHN).1
QUTENZA demonstrated pain reduction—starting as early as Week 11
PHN Study 12: Percent change in average pain for the past 24 hours NPRS scores by week
Mean percent changes in NPRS scores from baseline to Week 8 were -29% for QUTENZA vs -18% for control (P=0.001).
Results from a 12-week, double-blind, randomized, dose-controlled, multicenter study of 402 patients with PHN.1
With QUTENZA,
Pain scores decreased about 30% and sustained through Week 121
PHN Study 23: Percent change in average pain for the past 24 hours NPRS scores by week
Mean percent changes in NPRS scores from baseline to Week 8 were -33% for QUTENZA vs -26% for control (P=0.011).
Results from a 12-week, double-blind, randomized, dose-controlled, multicenter study of 416 patients with PHN.1
In both studies, some patients experienced significant pain reduction through 12 weeks.1
Note: The control used in these studies appeared identical to QUTENZA and contained a low (0.04%) concentration of capsaicin to retain blinding.1
Secondary endpoint: Over 40% of patients achieved ≥30% reduction in pain scores1
Percentage of patients achieving ≥30% reduction in mean NPRS scores2,3
(Baseline to Weeks 2-12; P=nominal)
In the QUTENZA arm of Study 2,
Secondary endpoint: 30% of patients achieved ≥50% reduction in pain scores1
Percentage of patients achieving ≥50% reduction in mean NPRS score3
(Baseline to Weeks 2-12; P=nominal)
Efficacy was demonstrated regardless of concomitant use of other medications
Approximately half 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.1
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.