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Sprout Pharmaceuticals has successfully sent Flibanserin to be reviewed by the Food and Drug Administration (FDA). The drug would be for women suffering from Hypo-Active Sexual Desire Disorder (HSDD).

This disorder, according to an academic article in the Journal of Sexual Medicine, might affect about 10% of premenopausal women. HSDD is described as a persistent lack of sexual desire or thoughts, which becomes a concern and may affect interpersonal relationships.

A recent clinical trial reported significant results. Participating premenopausal women suffering from HSDD were randomised and then had to take either flibanserin or a placebo pill once a day at bedtime for 24 weeks. The women taking flibanserin reported, at the end of the trial, a higher number of satisfying sexual events and lower level of distress compared to women taking the placebo pill. Side effects included nausea, dizziness and sleepiness.

This submission of the drug for review is a response to the growing concern about women’s sexual dysfunctions addressed in the Prescription Drug User Fee Act (PDUFA) V of 2012. The results of this trial are very interesting, and the FDA is expected to review the drug at some point before the end of the year. You can read more about the study at this online library.

We know that many observers of medical innovations are highly sceptical about the existence of HSDD but we can tell them from clinical practice that it is very real for some women and it has destroyed relationships. This is why this area of medicine is one of 20 highlighted as a priority for new product innovations.

Flibanserin is no more. Boehringer, the German pharmaceutical company behind this new drug, has announced that it will discontinue development of Flibanserin, which has been in clinical trials and developed for the treatment of hypoactive sexual desire disorder in women.

Regulators are unsupportive of the research thus carried out and Boehringer has decided that it would be too trying to continue with developments in the face of such questioning and opposition. The FDA’s disapproval came from fears regarding the lack of safety and efficacy of the drug in June of this year and made a 10-1 decision that Flibanserin was not effective and that the noted side- effects were not acceptable. These effects included loss of consciousness and depression.

Andreas Barner, chairman of Boehringer, states that he is confident of the potential for Flibanserin as a treatment for Hypoactive Sexual Desire Disorder (HSDD). He hopes that they have laid a good basis upon which research may continue in the medical community into the causes and potential treatment for HSDD. To this end, Boehringer will actually complete the latest clinical studies in order to advance and expand the knowledge base surrounding HSDD.

We think that this is a great pity as most of the women who were taking the medication in clinical trials did not want to give the pills back as they had so revolutionised their sex lives! Hopefully someone will pick up the reins on this one and take it forward.

As expected, the panel convened by the Federal Food and Drug Administration has voted against granting Boeringer Ingelheim’s Hypoactive Sexual Desire Disorder medication flibanserin approval.

The panel was chaired by Julia Johnson, the chief of obstetrics and gynaecology at the Medical School of the University of Massachusetts. She said in a statement that the drug was not sufficiently effective to outweigh the risks that it posed. The panel voted unanimously against it.

Boeringer said that Flibanserin, also known by its commercial name Girosa, controlled the levels of dopamine and norepinehrine, which both act on sexual desire. It also reduced the level of serotonin, which is thought to lower libido.

Analysis of two trials into the drug, which was originally developed as an anti-depressant, indicated that the difference the medication made to women’s sexual desire when compared to those taking the placebo was not convincing enough to demonstrate a statistically significant improvement in libido.

Though not required to do so by law, the FDA generally follows the recommendations of its panels.

Boehringer have vowed to continue to work on the treatment and have said they plan to work with the FDA to address the concerns raised by the advisory committee. They drew attention to the fact that the committee recognised that there was a significant unmet medical need for women suffering from Hypoactive Sexual Desire Disorder and they pointed out that there is still no FDA approved treatment for the condition.

The pharmaceutical industry is waiting eagerly for the FDA to take a vote on whether to approve the controversial new drug flibanserin, which is designed to treat Hypoactive Sexual Desire Disorder (HSDD) in women.

The FDA has already released a report, prepared as background information to the vote taking place today. It expresses concerns about the safety of the drug, directing the committee to consider whether women would be alerted by the labelling to the extensive possible drug interactions. It also expressed concerns as to whether members of the general public taking other medications or with histories of psychiatric disorders would respond well, as the report stated that the population taking part in the trials were generally healthy and taking few, if any, concomitant medications.

Aside from issues of safety and tolerability, the prospect of the drug being approved has stirred up a huge amount of debate over whether this is just a case of the pharmaceutical industry trying to profit from women’s sexuality.

While Boeringer (the company that developed Flibanserin) has launched an aggressive campaign to educate the public about HSDD (including a documentary for the Discovery channel and a tour by an ex-Playboy model who describes herself as suffering from HSDD) there is still a huge amount of concern that the underlying psychological causes of low libido might be ignored.

Some doctors believe that HSDD can be treated medicinally, others believe in psychotherapy and counselling. Perhaps the only thing that will decide the best way forward is when there is a medication available, offering women options to treat the condition.

That choice could still involve Flibanserin. As the New York Times pointed out, staff reports do not necessarily indicate which way an FDA panel will vote, and even the vote does not predetermine the final decision. Watch this space...

Boehringer Ingelheim has posted new late-stage data from their clinical trials into their libido-boosting drug Flibanserin, which they are currently waiting for the European Medicines Agency and the Food and Drugs Agency to approve.

The findings from the Phase III trials were presented at the annual meeting of the American College of Obtetricians and Gynaecologists showed that a high proportion of the women taking Flibanserin at the 100 mg dose reported that, compared with the placebo, there was a significant improvement in their condition.

The study involved 1,378 women who are pre-menopausal who used a 7-point scale to assess the severity of their Hypoactive Sexual Desire Disorder (HSDD) and whether the medication made a difference to their libido.

After 24 weeks, 48.3% of the women said that they felt their condition was very much improved, compared with 30.3% taking the placebo. This counts as a statistically significant difference, which the FDA and other regulators consider alongside other matters when deciding whether or not to approve a new medication.

The panel from the FDA is set to vote in mid-June as to whether or not to grant approval. If they do, Flibanserin will become the first oral medication to be approved for the treatment of HSDD in pre-menopausal women. We do not yet have a target date for the European Medicines Agency.

Currently there is some confusion about low libido with women, with some doctors arguing that the medicalisation of the condition will lead to psychological reasons for sexual problems being overlooked. However, others think that the drug is a huge step forward and will encourage doctors and patients to discuss the problem more openly.