The Food and Drug Administration (FDA) has approved Qutenza® (capsaicin 8% patch; Averitas Pharma) for the treatment of neuropathic pain associated with diabetic peripheral neuropathy of the feet.
The approval was based on data from a 12-week, multicenter, double-blind, placebo-controlled phase 3 study that evaluated the efficacy and safety of Qutenza in patients with neuropathic pain associated with diabetic peripheral neuropathy diagnosed at least 1 year prior to screening. Patients were randomized to receive either Qutenza or placebo applied as a single 30-minute application; baseline mean pain score was 6.51 on an 11-point Numerical Pain Rating Scale (NPRS). Roughly half of the study patients (47.2%) were taking concomitant medications for neuropathic pain, including anticonvulsants and non-SSRI antidepressants.
Results showed that the percent change in average pain from baseline to week 12 was -30% (±3%) with Qutenza compared with -22% (±3%) with placebo. Additionally, the least-squares mean change on the 11-point NPRS was -1.92 for Qutenza compared with -1.37 for placebo (least-squares mean difference of -0.56; 95% CI, -0.98, -0.14).
With regard to safety, the most common adverse reactions associated with Qutenza treatment included application site erythema, pain and pruritus. In the trial, a topical anesthetic was applied to the treatment area for 30 minutes prior to patch application. Patients were permitted to use local cooling and additional analgesic medications for treatment-related discomfort.
The recommended dose of Qutenza for neuropathic pain associated with diabetic peripheral neuropathy is a single, 30-minute application on the feet of up to 4 patches.
Each Qutenza patch contains a total of 179mg of capsaicin. The treatment should only be administered by a healthcare professional and should not be dispensed to patients for self-administration.
Qutenza is also indicated for the management of neuropathic pain associated with postherpetic neuralgia.
For more information visit qutenza.com.