Female Libido Drug, Flibanserin, Discontinued After Regulatory Feedback

Flibanserin, an investigational drug for pre-menopausal women with decreased sexual desire, known as Hypoactive Sexual Desire Disorder or HSDD, has been discontinued by its creator Boehringer Ingelheim following the Food and Drug Administration's (FDA's) safety query - the regulatory agency said that the compound's safety and efficacy were not proven. Hypoactive Sexual Desire Disorder is characterized by an absence or lack of desire for sexual activity as well as sexual fantasies for a prolonged period. It is classed as a disorder when the patient experiences distress and interpersonal difficulties which cannot be accounted for by, for example depression or some other mental disorder, a medical condition, or a substance.

Despite discontinuing flibanserin, Boehringer Ingelheim stresses that the compound would have been of value for pre-menopausal women with HSDD, a condition that affects a considerable number of adult females worldwide, and impacts on their lives.

Professor Andreas Barner, Chairman of the Board of Managing Directors of Boehringer Ingelheim and responsible for the Corporate Board Division Pharma Research, Development and Medicine, said:

The decision was not made lightly, considering the advanced stage of development. We remain convinced of the positive benefit-risk ratio of flibanserin for women suffering with HSDD.

In a communiqué, Boehringer Ingelheim explains that responding to the regulatory query and the subsequent complexities of getting the new compound ready for submission for approval contributed to the company's decision to drop flibanserin and focus on other products.

The Reproductive Health Drugs Advisory Committee, USA had met in Washington in June this year to review the NDA (new drug application) for flibanserin for HSDD treatment for pre-menopausal women. The Committee recommended that the FDA gather additional data regarding the compound's safety and efficacy before proceeding. In August the FDA issued is Complete Response Letter to the NDA.

Michael Sand, Director, Clinical Research and Global Strategic Leader of flibanserin, Boehringer Ingelheim, said:

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.

Boehringer Ingelheim says it now aims to focus on new compounds targeted at such areas as diabetes, oncology and stroke prevention.

Libido drugs, a term sometimes used for medications to treat HSDD, have been the focus of several large drug companies, and without much success. In 2004 Pfizer's attempts to get Viagra to be included as therapy for women was abandoned, Procter & Gamble tried to get a testosterone patch approved, and failed.

Source: Boehringer Ingelheim

Written by Christian Nordqvist

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