Success for Qutenza (capsaicin 8% patch) in comparison trial with pregabalin capsules for treament of peripheral neuropathic pain.- Astellas

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 (Qutenza) with pregabalin capsules (flexible, optimised dose) in adult patients with peripheral neuropathic pain (PNP) . 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.

The ELEVATE study 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. 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]). 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).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. Results showed a difference in patient perception of treatment effectiveness, side effects and treatment satisfaction that were in favour of the capsaicin 8% patch.