Astellas Pharma Europe Ltd has announced that the European Commission has granted approval for a label extension for QUTENZA (capsaicin 8% patch) 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 authorization by the European Commission in May 2009 with a licence that excluded adult patients with diabetes.
“This is significant for those suffering with the debilitating effects of painful diabetic peripheral neuropathy (pDPN) as they now have a new treatment option. This decision reinforces the efficacy and tolerability of the capsaicin 8% patch in a wide range of patients, as well as the commitment of Astellas to help patients with this difficult-to-treat condition,” commented Kay Drake, Senior Vice President Marketing, Astellas Pharma EMEA.
The European Commission decision follows the positive opinion from the Committee for Medicinal Products for Human Use provided in July 2015. The approval is based on outcomes of two clinical trials examining the efficacy and safety of the capsaicin 8% patch in patients with pDPN.
pDPN is a debilitating condition that may affect one in four patients with type 2 diabetes. The capsaicin 8% patch acts by directly targeting the source of neuropathic pain. 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.