Astellas Pharma Europe Ltd. has announced the publication in the European Journal of Pain of a head to head, non-inferiority study that compared the capsaicin 8% patch (QUTENZATM) with pregabalin capsules (flexible, optimised dose) in adult patients with peripheral neuropathic pain (PNP).1 The authors conclude that the capsaicin 8% patch provided non-inferior pain relief compared with pregabalin, in addition to a shorter median time to pain relief, fewer systemic side effects and greater treatment satisfaction.2

The ELEVATE study1 had a randomised, open-label, 8-week, non-inferiority design and included 559 adults with moderate-to-severe PNP. Patients were randomised to receive either a single treatment with the capsaicin 8% patch or daily administration of an optimised dose of oral pregabalin. The study met its primary endpoint of non-inferiority for pain relief, defined by a ≥30% decrease in mean numeric pain rating scale (NPRS) score from baseline to Week 8.2 The 30% responder rate was 55.7% in the capsaicin 8% patch arm, compared with 54.5% in the pregabalin arm (odds ratio [95% CI]: 1.03 [0.71, 1.50]).2 Moreover, the median time to pain relief with the capsaicin 8% patch was 7.5 days, compared with 36.0 days [including titration period] with pregabalin (hazard ratio [95% CI]: 1.68 [1.35, 2.08]; p<0.0001).2

Commenting on the results of ELEVATE, Professor Maija Haanpää, Principal Study Investigator, Department of Neurosurgery, Helsinki University Central Hospital, Helsinki, Finland said: "This is an important and well-conducted study that was designed to mimic everyday practice, allowing those patients randomised to the pregabalin arm to be individually titrated to the optimal tolerated dose. We found that topical treatment with the capsaicin 8% patch was non-inferior to the current standard of care. This means that there is now another treatment option for people with peripheral neuropathic pain, especially those patients who are very sensitive to the side effects of systemic medication or for those who do not wish to take tablets every day."

Secondary endpoints included optimal therapeutic effect (assessed using a composite endpoint including pain relief, adverse events and treatment discontinuation), median time to pain relief (defined as when 50% of patients had a 30% reduction in NPRS score) and treatment satisfaction.2 Results showed a difference in patient perception of treatment effectiveness, side effects and treatment satisfaction that were in favour of the capsaicin 8% patch.2

"Some patients may still receive inadequate pain management and have to balance effective pain relief and the side effects of their medication. The capsaicin 8% patch is applied topically and hence has shown less systemic side effects than seen with oral medications. There is a need to tailor treatment to individual patients and these data show that the capsaicin 8% patch is an efficacious agent to manage patients with peripheral neuropathic pain," commented Dr Andreas Karas, Senior Director, Medical Affairs, Astellas Pharma EMEA.

The proportion of drug-related treatment emergent adverse events (TEAEs) was 54.5% for pregabalin and 61.3% for the capsaicin 8% patch.2 TEAEs leading to permanent discontinuation of study drug were only reported in the pregabalin arm (n=24, 8.5%).2 With the capsaicin 8% patch, the majority of drug-related TEAEs were transient and related to the application site.2 In comparison, pregabalian was associated with systemic adverse drug reactions (ADRs).2 Systemic ADRs ranged from 0-1.1% for the capsaicin patch and 2.5-18.4% for pregabalin.2

In September this year, the European Commission granted approval for a label extension for QUTENZATM (capsaicin 8% patch) for the treatment of peripheral neuropathic pain in adults, including adult diabetic patients with peripheral neuropathic pain, either alone or in combination with other medicinal products for pain.2