EU approves label extension for Qutenza (capsaicin 8% patch) for diabetic patients with peripheral neuropathic pain-Astellas

The European Commission has granted approval for a label extension for Qutenza (capsaicin 8% patch), from Astellas, to include the treatment of adult diabetic patients with peripheral neuropathic pain, either alone or in combination with other medicinal products for pain. The capsaicin 8% patch was first granted marketing authorisation by the European Commission in May 2009 with a licence that excluded adult patients with diabetes.

In non-diabetic patients it has demonstrated rapid, targeted pain relief directly to the area of pain giving patients significant pain relief for up to three months following a single application. Outcomes of clinical studies found the capsaicin 8% patch provided statistically significant improvements in pain relief and sleep quality in patients with pDPN, with no new safety issues associated with a single treatment or repeated treatment over 52 weeks.