EU approves expanded approval for Qutenza (Astellas) for Neuropathic Pain

The European Commission has approved expanded options for pre-treatment prior to use of Qutenza (8% capsaicin patch), from Astellas. Before application the patient may now take an oral analgesic, or the treatment area may be pre-treated with a topical anaesthetic. The 8% capsaicin patch is the first and only licensed high concentration (8%) capsaicin cutaneous patch for the treatment of Peripheral Neuropathic Pain. The submission was supported by data from the LIFT study, which aimed to investigate the use of an oral analgesic as an alternative form of pre-treatment for the 8% capsaicin patch.

Patients were randomised to either lidocaine cream or tramadol tablets, prior to application of the capsaicin patch. Patients were then treated with the 8% capsaicin patch for 60 minutes and followed up for 7 days to monitor pain scores and tolerability. The primary endpoint of the LIFT study was the proportion of subjects who tolerated 8% capsaicin patch treatment which was defined as a patient using the patch for at least 90% of the intended patch duration. Results are due in May 2013.