A new rival to blockbuster Cox-II inhibitor drugs from Pfizer and Merck Sharp & Dohme has been approved in the UK.

Novartis hope that clinical trials involving 13,000 patients the biggest ever in the class - will provide enough evidence of the effectiveness of Prexige (lumiracoxib) to make it a challenger to Pfizer Celebrex and MSD Vioxx, already established as two of the biggest selling drugs in the world.

The drug will also have to contend with the follow-up products in the same class, Pfizer Bextra and MSD Arcoxia.

Prexige has been approved for osteoarthritis pain relief (100-200mg) and short-term treatment of moderate to severe acute pain associated with primary dysmenorrhoea, dental surgery and orthopaedic surgery (400mg).

Analysts say Novartis stands a good chance of capturing market share from the existing players, and is looking to differentiate its product on safety and efficacy through a number of head-to-head studies.

Safety concerns about existing Cox-II drugs and price pressures in the US have seen growth in the class slow over the past few years, but the competitors are now looking to a sharp increase in uptake of the drugs in Europe.

pharmafocus@pharmafile.co.uk