Qutenza capsaicin regulatory update

Marketing partner Astellas Pharma Inc. (Tokyo:4503, Tokyo, Japan) said the European Commission approved an expanded label for Qutenza 8% capsaicin patch to include use with pretreatment options, including oral analgesics or topical anesthetics. The dermal patch containing capsaicin is approved in the EU to treat peripheral neuropathic pain in non-diabetic adults. In March 2012, EMA said Astellas withdrew an application for a label extension for Qutenza for use in diabetics who have peripheral neuropathic pain not caused by their diabetes after the agency's CHMP indicated the data provided was not sufficient to demonstrate a positive benefit-risk balance (see BioCentury, March 26, 2012). ...