New form of Levitra wins EU approval
pharmafile | September 7, 2010 | News story | Sales and Marketing | Bayer, Levitra, erectile dysfunction
Bayer is to launch a new formulation of its erectile dysfunction drug Levitra.
The European Commission granted Levitra (verdenafil HCI) a license as an ‘oral dispersible’ tablet, meaning it can be placed on the tongue to be dispersed into the bloodstream rather than having to be swallowed.
Bayer believes this is a more convenient and discreet method for men with erectile dysfunction (ED) and could give it an advantage over rival drugs from Pfizer (Viagra) and Lilly (Cialis), which have to be taken with water.
Bayer says it will begin European launches of Levitra’s new formulation in November of this year.
Dr Flemming Oernskov, head of the company’s women’s healthcare and general medicine business unit, said: “Bayer Schering Pharma is committed to men’s health and continuously striving to find new and innovative treatment options in the treatment of erectile dysfunction.
“As part of these efforts, we believe men with ED will appreciate a convenient and easy to take medication. Levitra orodispersible tablet allows men with ED to be prepared, anytime, anywhere. This should help to bring spontaneity into the sex life of men with ED.”
The data for the drug is based on POTENT I and II international twin studies that were conducted with identical study design, enrolling a total of 882 adult men who had suffered from ED for more than six months.
For both studies, Byaer said Levitra orodispersible tablets were “statistically significantly superior to placebo” for all primary and secondary efficacy measures.
Levitra’s new formulation was approved by US regulator the FDA in June where it is co-marketed by GlaxoSmithKline and MSD as Staxyn.
Ben Adams
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