This site is intended for residents of the United States only.
This site is intended for residents of the United States only.

Consider QUTENZA as your first add-on
treatment for PDPN of the feet

PDPN: painful diabetic peripheral neuropathy.
Not an actual patient.

Angle Shape

In a clinical study, QUTENZA was shown to provide sustained relief of pain associated with DPN and a faster time to treatment was achieved with QUTENZA vs placebo in adult patients after a single application

Pivotal Endpoint: QUTENZA delivered statistically and clinically significant pain relief from baseline to Week 12 (vs placebo)1,2

Secondary Endpoint: Proportion of patients achieving ≥30% reduction in pain from baseline1

Over 40% of patients achieved ≥30% reduction in pain scores
30% of patients achieved ≥50%reduction in pain scores

Average change in pain from baseline to Week 12: –30% for QUTENZA vs –22% for placebo.

Results from a 12-week, double-blind, randomized, placebo-controlled, multicenter study of 369 PDPN patients.

The least-squares mean change was -1.92 on the 11-point NPRS scale for QUTENZA, vs -1.37 for placebo, a least-squares mean difference of -0.56 (95% CI -0.98, -0.14).

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.

Pivotal Endpoint: QUTENZA delivered statistically and clinically significant pain relief from baseline to Week 12 (vs placebo)1,2

Over 40% of patients achieved ≥30% reduction in pain scores

Average change in pain from baseline to Week 12: –30% for QUTENZA vs –22% for placebo.

Results from a 12-week, double-blind, randomized, placebo-controlled, multicenter study of 369 PDPN patients.

The least-squares mean change was -1.92 on the 11-point NPRS scale for QUTENZA, vs -1.37 for placebo, a least-squares mean difference of -0.56 (95% CI -0.98, -0.14).

Secondary Endpoint: Proportion of patients achieving ≥30% reduction in pain from baseline1

30% of patients achieved ≥50%reduction in pain scores

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.

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.2

Webinar: QUTENZA in Clinical Trials: An Overview of Efficacy and Safety Data
Webinar: QUTENZA in Clinical Trials