Following regulatory feedback Boehringer Ingelheim decides to discontinue flibanserin development
Ingelheim (Germany), 08 October, 2010 – Boehringer Ingelheim announced today the decision to discontinue the development of its investigational compound flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD).
The company continues to believe in the value that flibanserin
would have for women suffering with HSDD, a significant and
recognised medical condition which impacts the lives of many women
around the world.
“The decision was not made lightly, considering the advanced stage of development,” said Professor Andreas Barner, Chairman of the Board of Managing Directors and responsible for the Corporate Board Division Pharma Research, Development and Medicine. “We remain convinced of the positive benefit-risk ratio of flibanserin for women suffering with HSDD.”
The response of the authorities and the complexity and extent of further questions that would need to be addressed to potentially obtain registration for flibanserin have impacted the company’s decision to focus on other pipeline projects. The company regularly reviews its pipeline projects and updates its priorities accordingly.
In June 2010, the Reproductive Health Drugs Advisory Committee met in Washington to discuss the new drug application (NDA) for flibanserin as a treatment for HSDD in pre-menopausal women. Members of the Committee advised that additional data would be necessary to further support the efficacy and safety profile of flibanserin. Following the Advisory Committee Meeting in June, the U.S. Food and Drug Administration (FDA) issued its Complete Response Letter to the NDA at the end of August.