Sprout Pharmaceuticals Appeals FDA Decision on NDA for Flibanserin to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women Raleigh, N.C., December 11, 2013 – Sprout Pharmaceuticals today announced that it has received and appealed the Food and Drug Administration's (FDA) Complete Response Letter (CRL) for flibanserin through the Formal Dispute Resolution process. Flibanserin is an investigational, once-daily treatment for Hypoactive Sexual Desire Disorder, or HSDD, in premenopausal women. HSDD is the most commonly reported form of female sexual dysfunction. The CRL was received in response to Sprout's re-submission of the new drug application (NDA) for flibanserin earlier this year. Sprout's resubmission included 14 new clinical studies with data on more than 3,000 new patients, expanding the number of subjects having completed clinical trials to more than 11,000, including more than 5,000 who were treated with flibanserin in Phase III efficacy studies. Sprout recently completed an end-of-review meeting in which the FDA provided the Company with a more complete understanding of its review of the NDA."Sprout strongly believes that it has satisfied the statutory requirements for approval of flibanserin," said Cindy Whitehead, president and chief operating officer of Sprout Pharmaceuticals. "In clinical trials, flibanserin has outperformed placebo with statistical significance and, importantly, women treated with flibanserin perceived their improvement to be clinically meaningful. What the Division characterizes as a modest effect in their risk/benefit evaluation, we see as meaningful effect on the hallmark characteristics of the condition. It is the basis of our dispute. It is true that flibanserin does not cause hypersexuality but by that definition, modest would be what we're aiming for. Further, in the risk/benefit evaluation, we believe that the safety profile of flibanserin is similar to that of other approved drugs where effect was characterized as modest by the agency and can be managed through a combination of labeling and responsible product launch, including post-market assessments and communications. If approved, flibanserin could meet an important unmet medical need for women." The FDA accepted the formal dispute resolution request on December 3, 2013. Based on the Agency's guidance, Sprout expects a response from the FDA on the appeal in the first quarter of 2014.
About the FDA's Formal Dispute Resolution Process The appeal was submitted in accordance with the Formal Dispute Resolution process that exists within FDA's Center for Drug Evaluation and Research (CDER). Responses to CDER appeals are typically made within 30 to 60 days. FDA regulations provide a mechanism for those seeking regulatory approval of a drug product pursuant to an NDA to obtain formal review of any Agency decision by raising the matter with the supervisor of the employee who made the decision. The process exists to encourage open, prompt discussion of scientific (including medical) disputes and procedural (including administrative) disputes that arise during the drug development, NDA review, and post-marketing oversight processes.
About Hypoactive Sexual Desire Disorder HSDD is the most commonly reported form of female sexual dysfunction. HSDD is defined as a persistent or recurrent deficiency or absence of sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty, and which is not better accounted for by a medical, substance-related, psychiatric (e.g., depression) or other sexual condition. The cause of HSDD is believed to involve a multitude of social, psychological and biological factors and may be attributed to a complex interplay of these factors.
About Flibanserin Flibanserin is a novel, non-hormonal drug that has been studied in clinical trials for the treatment of HSDD in premenopausal and postmenopausal women. The application submitted to the FDA is for premenopausal women only at this time. Flibanserin is believed to work on key neurotransmitters, or chemicals, in the brain that affect sexual desire. More specifically, it is thought that flibanserin corrects an imbalance of levels of these neurotransmitters by increasing dopamine and norepinephrine (both responsible for sexual excitement) and decreasing serotonin (responsible for sexual inhibition). In clinical studies, flibanserin was evaluated for its ability to increase the frequency of satisfying sexual events, increase the intensity of sexual desire and decrease the associated distress women feel from its loss.
About Sprout Pharmaceuticals Sprout Pharmaceuticals is passionate about women's sexual health. With a breakthrough concept for women, the company "sprouted" out of Slate Pharmaceuticals in 2011. Based in Raleigh, NC, the company is focused solely on the delivery of a treatment option for the unmet need of millions of women with HSDD. Sprout is currently and initially pursuing the FDA approval of flibanserin to treat HSDD in premenopausal women, for which there is currently no FDA-approved treatment. Source: Sprout Pharmaceuticals, Inc. Posted: December 2013
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.
Boehringer Ingelheim 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. Media contact, Boehringer Ingelheim, Director Corporate Communications, Julia Meyer-Kleinmann, Binger Strasse 173, 55216 Ingelheim am Rhein, GERMANY/ Posted: October 2010
Addyi Approval History
Aug 18, 2015 Approval FDA Approves Addyi (flibanserin) for Hypoactive Sexual Desire Disorder in Premenopausal Women/ Jun 4, 2015 FDA Advisory Committee Recommends Approval for Addyi (flibanserin) to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women/ Feb 17, 2015 Sprout Pharmaceuticals Resubmits Flibanserin NDA for Hypoactive Sexual Desire Disorder In Premenopausal Women/ Feb 11, 2014 Sprout Pharmaceuticals Receives Clear Guidance from FDA on Path Forward to Resubmit NDA for Flibanserin/ Dec 11, 2013 Sprout Pharmaceuticals Appeals FDA Decision on NDA for Flibanserin to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women/ Oct 8, 2010 Following Regulatory Feedback Boehringer Ingelheim Decides to Discontinue Flibanserin Development/ May 19, 2010 Boehringer Ingelheim Announces New Data on Flibanserin in Pre-Menopausal Women with Hypoactive Sexual Desire Disorder
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