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.

A new report has suggested that women suffering from female sexual dysfunction (FSD) are being prevented from seeking help due to societal and cultural barriers.

Published by Datamoniter, the report says that because the condition, charecterised by long-term low libido in women, is not life-threatening it is frequently ignored or dismissed by the medical community.

The head of women’s health analysis at DataMoniter, Maya Marescott, said that the stigma attached to talking about sex and sexual dysfunction in a clinical environment was acting as a barrier to doctors and patients discussing any sexual problems.

A recent study of healthcare providers in the US showed that only 34% of American doctors would bring up a discussion about sexual health with their patients while in the UK it was revealed that 75% of women would not discuss their sexual health with their GP, due to a belief they would not be interested.

Currently there is only one medication that GPs can prescribe to treat Female Sexual Dysfunction, Proctor and Gamble’s Intrinsa patch. However it is only suitable for post-menopausal women taking hormone replacement therapy.

Another company is developing a pill called Flbanserin that may be suitable for a much larger patient group and which has already had promising results in clinical trials, but it is unlikely to be available for at least a year.

However if it is approved it may encourage women to discuss the problem with the doctors – the advent of medical solutions such as Viagra did much to remove some of the stigma from erectile dysfunction.

Ms. Marescotti however warned that as FSD was a complicated condition, caused be a variety of factors, finding a ‘quick fix’ for the problem would be hard to achieve.

Good news for BioSante, a company conducting trials into a new treatment for female sexual dysfunction called Libigel. A data monitoring committee has recommended that the medication is suitable for continued trials after positive data on safety, taken from a phase III clinical trial, was released.

The review of the results involved the panel examining all the unblended adverse events in the safety study, including serious adverse events and cardiovascular and breast cancer events. So far, there have been no deaths, 6 patients developed cardiovascular problems and 4 breast cancer. The low rate of incidence means that the development programme has the go-ahead to continue.

A spokeswoman for BioSante said that their product was the lead pharmaceutical product in development in the US for FSD in surgically menopausal women and added that that they believed that the treatment, a form of testosterone patch, would be the first product to get approval from the FDA for the treatment of the condition.

They will be facing competition from the makers of Flibanserin, a pill which has had extremely promising results in pre-and-post menopausal women suffering from Hypoactive Sexual Desire Disorder.

The company hope to submit Libigel to the FDA for a new drug application in mid-2011. After the results were announced, shares in the company went up by 5%.

The pharmaceutical firm Vivus has announced that their chief executive officer Leland Wilson will present an overview of the company next week, where they are expected to give an update on a variety of new treatments, including a product to combat hypoactive sexual desire disorder in women. They have already said they are currently looking for a partner with whom they can go forward with clinical trials into their treatment for female sexual dysfunction, Luramist.

The product is a hand-held spray which delivers testosterone and proprietary skin penetration enhancers directly to the skin of women suffering from hypoactive sexual desire disorder. They believe that for pre-menopausal women, the delivery of testosterone to their system will increase the number of satisfying sexual experiences the women have a month.

The product is one of a few being developed to improve female sexual desire, with perhaps the most famous being flibaneserin, nick-named ‘female viagra’. Originally developed as an anti-depressant, pharmaceutical firm Boeringer Ingelheim discovered that while it did not affect mood, it did increase sexual desire in women who had been diagnosed as suffering from HSDD.

Currently undergoing clinical trials, there is significant interest in the pill, as it uses a different mechanism to promote desire from the majority of treatments being developed. Most medications for HSDD in the pipeline use testosterone as the key ingredient in their treatment, such as Lumamist and BioSante’s Libigel.

At the moment, the only treatment for HSDD is Intrinsa, a patch only suitable for post-menopausal women. As the new treatments are largely aimed at pre-menopausal women, the companies involved are hopeful that they will be able to garner significant sales from this large section of the population who currently have no medical recourse to combat the condition.

Valentine’s Day has just been and across the world, millions of men tried to charm the women in their life with extravagant gifts of chocolate. It’s one of the most profitable periods in the year for chocolate manufactures and many people believe that the treat is an aphrodisiac.

Most women will experience some decrease in desire at certain points in their life, but for some women it can be a permanent condition, known as hypoactive sexual desire disorder, or HSDD. So could chocolate really help those suffering from this condition?

Perhaps the many women who swear chocolate can have a huge impact on their mood will be unsurprised by the findings of an Italian scientist, who claims yes.  Published in the Journal of Sexual Medicine, Dr. Andra Salonia and her colleagues collated data on women’s chocolate consumption, combined with information about their sexual function and levels of depression.

They discovered that women who ate chocolate every day were likely to score higher on the Female Sexual Function index than those who did not. The authors however noted that women who ate chocolate daily were likely to be younger, which might impact on their sexual function scores.

Whether or not chocolate could have potential for treating the disorder, HSDD is increasingly receiving attention from  pharmaceutical firms eager to find a medical cure for the condition. Perhaps the most exciting of the drugs in the pipeline is Flibanserin, a pill that is being touted as ‘female Viagra’.

Trials have already shown the medication significantly increased sexual desire in the women who took part in Boeringer Ingelheim’s trials, which are still ongoing.

Many women (and their partners) are watching the progress of the medication through the different trial stages with interest, but since it could be some time until the medication receives approval, they might do worse than to invest in a nice bar of 70% cocoa.

It is already known to increase serotonin and endorphin levels, acting as a mild anti-depressant, and contains phenylethylamine, produced by the brain when we fall in love.

Well, if it was good enough for Aztec emperor Montezuma (who apparently used cocoa to increase his sex drive) then there’s no harm in trying....

Boehringer Ingelheim, the drugs company researching the potential of the new medication flibanserin, are currently recruiting women suffering from hypoactive sexual desire disorder (HSDD) to take part in clinical trials into the drug in the US.

Touted as ‘female viagra’ the pill in previous trials was shown to increase the number of positive sexual events experienced by women suffering from HSDD. Originally developed as an anti-depressant, the drug performed badly in clinical trials but there were reports that women were experiencing increased libido, with some women even proving unwilling to give the medication back.

Women who took part in the trials reported that after taking a daily 100mg dose of flibanserin, they had more sexually satisfying events, compared with those taking the placebo. Prior to the trial they reported experiencing 2.8 positive sexual events per month, which rose to 4.5 times a month while taking the medication. Women on the placebo enjoyed 1.7 more positive sexual events than before.

The previous trial in Europe involved 2,000 women aged over 18 with sexual problems but it is unclear how many will be involved in the upcoming trial.