A version of Bayer's erectile dysfunction drug Levitra which dissolves on the tongue has been given the green light by regulators in Europe.
The German group says the European Commission has approved a new formulation of Levitra (vardenafil), a 10mg orodispersible tablet. It will be the first ED medication available "in this novel and convenient formulation".
Bayer added that in contrast to other drugs of the same class, notably Viagra (sildenafil), Levitra allows men "a discreet and convenient intake without water, dissolving on the tongue within seconds with a minty flavour". In Europe, the launch roll-out will start in November.
The approval is based on data from two international twin studies enrolling a total of 882 men above the age of 18 who had ED for more than six months. For both POTENT I and POTENT II studies, vardenafil orodispersible was "statistically significantly superior to placebo," Bayer noted.
Flemming Oernskov, head of women's healthcare and general medicine at Bayer Schering Pharma, said that men with ED "will appreciate a convenient and easy to take medication". He added that the new version allows men to be prepared "anytime, anywhere" and "this should help to bring spontaneity into the sex life of men with ED.”
The orodispersible drug was approved in the USA in June, where it will be marketed by GlaxoSmithKline and Merck & Co under the tradename Staxyn.