All 26 EU member states have agreed to issue national approval to Prexige. Novartis also reported that the drug has been authorized in Canada. Initial approval for Prexige was granted in the UK, where it has been available since December 2005.
Prexige is an oral selective COX-2 inhibitor that offers similar pain relief to the commonly used osteoarthritis medication. However it has demonstrated a superior safety profile to traditional the non-steroidal anti-inflammatory drugs (NSAID).
The decision to approve Prexige was based on data from clinical trials that demonstrated the drug significantly reduced the incidence of serious gastrointestinal complications by 79% compared with NSAIDs.
COX-2 inhibitors have a risky safety profile, with some research suggesting a link to heart attacks. Merck & Co pulled its COX-2 inhibitor, Vioxx, from the market after serous side effects were reported.
Health authorities have concluded that the benefit/risk ratio for NSAIDs and selective COX-2 inhibitors remains positive when used in their target patient populations.