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CHMP upholds fentanyl recommendation in referral re-examination

This article was originally published in Scrip

Executive Summary

In a referral re-examination, the CHMPhas again recommended that marketing authorisation be refused, or where appropriate withdrawn, for Stada Arzneimittel's fentanyl-based transdermal patches (Fentastad, Fentador, Fentrans, Matrigesic and Matripain) indicated for the treatment of severe pain. The CHMP originally adopted a negative opinion in November 2007, claiming that the product did not adequately show the characteristics considered to be key requirements in guaranteeing safety and efficacy. The CHMP confirmed this outcome for all doses in a re-examination that was requested by the company. However, in April, the European Commission referred the opinion back to the CHMP for more clarity regarding the arguments used to refuse authorisation for the lowest patch strength (25 μg/hr patch).

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