sábado, 19 de junho de 2010

German 'female Viagra' fails to excite US drug approval agency

A German attempt to develop a drug to help boost women’s sex drive has been knocked back by the US Food and Drug Administration, which said there was no evidence to show it was effective or safe. 


Flibanserin, developed by Rhineland pharma company Boehringer Ingelheim, had been aimed at post-menopausal women dissatisfied with their libido, which often declines later in life. 

The candidate-drug was inevitably labelled a ‘female Viagra’ although it was designed to tackle desire rather than ability. 

But the company’s application for marketing license in the US was rejected on Friday night after the FDA advisory panel voted unanimously against approval. 

"The efficacy was not sufficiently robust to justify the risks," said panel chair Julia Johnson, chief of obstetrics and gynecology at the University of Massachusetts Medical School, after the committee's deliberations.

The FDA usually follows these panels' advice, even though it is not required to do so by law.