Boehringer Ingelheim halts development of flibanserin

Publicado el 08 octubre 2010 por Fat
Boehringer Ingelheim announced that it will cease development of flibanserin, an experimental compound for the treatment of hypoactive sexual desire disorder (HSDD), after US regulators questioned the safety and efficacy of the drug. The company said the decision was based on the "complexity and extent of further questions that would need to be addressed to potentially obtain registration."
In June, an FDA panel unanimously voted against recommending approval of flibanserin after panel members concluded that the drug’s impact was "not robust enough to justify the risks."
Commenting on the news, Boehringer Ingelheim CEO, Andreas Barner, said that "the decision was not made lightly, considering the advanced stage of development" of the drug. He added that "we remain convinced of the positive benefit-risk ratio of flibanserin for women suffering with HSDD." The company said it would complete the two most advanced clinical studies of the drug to increase knowledge for the scientific community, but would reallocate resources to areas including stroke prevention, diabetes and oncology.
Reference Articles
Boehringer abandons female desire drug, citing FDA - (Bloomberg)
Following regulatory feedback Boehringer Ingelheim decides to discontinue flibanserin development - (Boehringer Ingelheim)
Boehringer pulls the plug on 'Pink Viagra' - (FOX Business)
Boehringer Ingelheim stoppt Frauen-Lustpille - (Financial Times Deutschland)
German company drops female sex pill - (Forbes)
Boehringer halts development of 'Female Viagra' (free preview) - (The Wall Street Journal)
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