Pre-treatments for peripheral neuropathic pain patch receive European Commision approval

Astellas Pharma Europe Ltd.Mar 14 2013

The European Commission (EC) has approved expanded options for pre-treatment prior to use of QUTENZA (8% capsaicin patch). Before application the patient may now take an oral analgesic, or the treatment area may be pre-treated with a topical anaesthetic.¹ The 8% capsaicin patch is the first and only licensed high concentration (8%) capsaicin cutaneous patch for the treatment of peripheral neuropathic pain in Europe.

The EC approval of the 8% capsaicin patch label amendment is valid in all of the 27 European Union Member States plus Iceland, Liechtenstein and Norway. The regulatory 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.

In the LIFT study patients were randomised to either application of lidocaine cream (a topical anaesthetic) or tramadol tablets (an oral analgesic), prior to application of the 8% capsaicin patch.^2,3 All 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. The LIFT study was completed in April 2012 and the results will be presented at The 4th International Congress on Neuropathic Pain (NeuPSIG) in May 2013.

Dr. Arun Bhaskar, Consultant in Pain Medicine, Anaesthesia & Critical Care at The Christie NHS Foundation Trust in Manchester says, “The 8% capsaicin patch has been a useful addition to the management of difficult-to-treat neuropathic pain conditions like post-herpetic neuralgia, HIV neuropathy and chemotherapy-induced neuropathy. This label change will provide greater flexibility to treating clinicians and should enable them to carry out treatment of more patients per session, thus reducing the cost of treatment per patient.”

Anne Hodgkins, Senior Brand Director, Pain Management at Astellas Pharma Europe Ltd commented, “Managing peripheral neuropathic pain is challenging and the individual needs of the patient are paramount when treatment decisions are made. We are committed to ensuring the 8% capsaicin patch is an accessible and convenient treatment option for physicians and patients.”

Conventional therapies for peripheral neuropathic pain can be restricted by factors such as systemic side effects, drug-drug interactions, slow onset of action, the need for titration and multiple daily dosing.^4,5,6 The 8% capsaicin patch is designed to act locally on the affected area and has not been associated with the systemic side effects such as sedation and dizziness.^4,5,7

QUT/12/0024/EU

March 2013

References

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