AddyiTreatment for Hypoactive Sexual Desire Disorder
Update: Addyi (flibanserin) Now FDA Approved - August 18, 2015
Following Regulatory Feedback Boehringer Ingelheim Decides to Discontinue Flibanserin Development
Boehringer Ingelheim continues to believe in the value that flibanserin would have for women suffering with HSDD. Company will still complete the two most advanced clinical studies.
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.
Boehringer Ingelheim is proud to have contributed to an increased understanding of HSDD through its significant investment into research, development and educational activities. The company will complete the two most advanced clinical studies to add knowledge for the scientific community and women suffering with HSDD.
“The need for a better understanding of HSDD and its possible treatment continues, and we hope the scientific and medical communities will build on the knowledge that Boehringer Ingelheim’s research has provided to find solutions for women who suffer with this disorder,” said Michael Sand, Director, Clinical Research and Global Strategic Leader of flibanserin, Boehringer Ingelheim.
In view of the broad range of therapeutic areas that the Boehringer Ingelheim pipeline currently comprises, the company will be able to re-allocate resources to other areas, such as stroke prevention, diabetes and oncology.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed for 125 years to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro while spending 21% of net sales in its largest business segment Prescription Medicines on research and development.
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Posted: October 2010
- FDA Approves Addyi (flibanserin) for Hypoactive Sexual Desire Disorder in Premenopausal Women - August 18, 2015
- FDA Advisory Committee Recommends Approval for Addyi (flibanserin) to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women - June 4, 2015
- Sprout Pharmaceuticals Resubmits Flibanserin NDA for Hypoactive Sexual Desire Disorder In Premenopausal Women - February 17, 2015
- Sprout Pharmaceuticals Receives Clear Guidance from FDA on Path Forward to Resubmit NDA for Flibanserin - February 11, 2014
- Sprout Pharmaceuticals Appeals FDA Decision on NDA for Flibanserin to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women - December 11, 2013
- Boehringer Ingelheim Announces New Data on Flibanserin in Pre-Menopausal Women with Hypoactive Sexual Desire Disorder - May 19, 2010
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