Bayer Schering Pharma granted EU clearance for erectile dysfunction drug

Bayer Schering Pharma has received authorisation from the European Commission to launch its new tablet-based erectile dysfunction (ED) drug Levitra in Europe.

The new medication, which is a discreet orodispersible tablet with a minty flavour that can be taken without water, is expected to be introduced into European markets in November 2010.

Its efficacy and safety have been verified in a number of international phase III clinical trials, which demonstrated the drug's effectiveness when compared to placebo.

The European launch of the drug follows its US debut earlier this year, where it is marketed by GlaxoSmithKline and Merck Sharpe and Dohme under the brandname Staxyn.

Dr Flemming Oernskov, head of the women's healthcare and general medicine business unit at Bayer Schering Pharma, said: "Levitra orodispersible tablets allow men with ED to be prepared anytime, anywhere. This should help to bring spontaneity into the sex life of men with ED."

Last week, Bayer Schering Pharma published data from a recent phase III clinical trial of its drug rivaroxaban, demonstrating the treatment's efficacy in reducing recurrent venous thromboembolisms among deep vein thrombosis patients.