Female Viagra drug Flibanserin on the cusp of FDA approval

Since Pfizer’s male impotence wonder drug Viagra first burst onto the scene an incredible 17 years ago, it was subsequently joined by Eli Lily’s Cialis and Bayer’s Levitra by 2003.

Over the next 12 years the industry has witnessed variations on these such as the lower-strength Cialis Daily tablets for the more ‘active’ male and Levitra orodispersible tablets – especially suitable for men who aren’t comfortable with swallowing pills, wanting to take it with some discretion and without the requirement of a glass of water.

Men also have the options of the newer erectile dysfunction treatment Spedra (Avanafil) or Vitaros cream – ideal for men that have not experienced success with the aforementioned PDE5 inhibitor tablets or cannot take PDE5s for medical reasons.

If all that wasn’t enough choice, men suffering with premature ejaculation have over-the-counter premature ejaculation treatments such as Stud 100 Spray, condoms containing benzocaine like Durex Performa (to prolong climax), whilst there is also prescription medication such as Priligy, which is taken orally and works to prolong a man’s sexual performance by an average of 200% to 300%.
Simply put, men are spoilt for choice when it comes to finding the right treatment option for sexual dysfunction, whether this be for persistent impotence or premature ejaculation problems.

So, what is there for women? If Medical Specialists® Pharmacy were to quiz our thousands of patients to come up with the name of an existing female sexual dysfunction treatment, we’d be surprised if anyone could muster a reply.

In early 2014 Medical Specialists® reported how British pharmaceutical company ORLIBID were developing a drug tentatively titled ‘ORL101’, aimed at boosting a woman’s sex drive, however no further information has been released about ORL101 since then.

However, Medical Specialists® are delighted to announce that a new pill to boost a woman’s libido could be one step closer after US experts gave its endorsement. This will be fantastic news for those that have fought for women’s sex drives to get a similar medical attention to deal put into it as the male treatments.

A panel of Food and Drug Administration (FDA) advisers decided to vote 18-6 in favour of recommending flibanserin, a daily pill nicknamed the ‘female Viagra’ and manufactured by Sprout Pharmaceuticals, who picked up the drug back in 2011 after its initial developer, Boehringer Ingelheim, decided to drop it.

The vote came following a testimony from various women who vigorously persuaded the agency to approve the drug and told of their fear of never being able to have sex again. The final judgement of course will have to come from the FDA themselves, with a verdict on suitability for public use due later this year.

Coincidentally, flibanserin, just like the discovery of Viagra, was an unintended find. The drug was firstly developed with the intention of treating depression, but wasn’t as effective for this purpose as expected.

Many of the 11,000 women involved in the trials did note that they were experiencing some rather unexpected side effects from the flibanserin. Increased sexual interest and overall, more satisfying sexual experiences than previous, were being commonly reported.

North Carolina drug maker Sprout Pharmaceuticals, have claimed that their clinical trials have demonstrated that women have experienced a 37% rise in sexual desire in comparison to a placebo. The women reported an average of between 0.5 and one more sexually satisfying events each month, compared to those women taking a placebo. In addition, they had higher scores on questionnaires on desire and scored lower on questions about stress.

The drug – which changes brain chemistry as opposed to Viagra increasing blood flow – isn’t without a chequered history though, with the FDA twice rejecting the drug since 2010, arguing flibanserin’s benefits did not outweigh the risks, which can include low blood pressure and fainting spells.

However, Susan Scanlan, chairwoman of Even The Score, hit back and noted that Viagra can have varying side effects, arguing that the FDA hasn’t approved flibanserin because of their discomfort with women taking control over their sexuality. “The implication is that men can be trusted to make a rational decision of risk versus reward and women can’t,” she said.

The FDA has highlighted female sexual dysfunction as one of 20 priority areas of unmet medical need, and is obviously a major and genuine health problem that needs to be addressed.

Keep checking the Medical Specialists® NHS Pharmacy website for further updates about flibanserin or other female sexual dysfunction products that may become available in the future, and we already have an extension range of male impotence and premature ejaculation treatments, some of which were mentioned earlier.

‘Viagra for women’ may be available in 2016

In just three years’ time, it could be that men are not the only sex who get a helping hand in the bedroom, as Dutch scientists are developing two new drugs to cure the loss of a woman’s desire, one of which is a testosterone-based therapy to heighten pleasure.

The revolutionary new drugs Lybrido and Lybridos, or ‘Female Viagra’ as they are being nicknamed, are being developed by Dutch and US firm Emotional Brain, who claim either could be on bedside cabinets across the world by 2016, being used to boost a woman’s sexual desire and increase feelings of satisfaction in the bedroom.

Currently, men hugely benefit through medicines such as Viagra, Cialis or Levitra for impotence, in addition to Priligy and Stud 100 spray for premature ejaculation. Women’s bedroom issues are often overlooked and ignored, but not for much longer!

The creators Emotional Brain were founded in 2001 primarily to pioneer innovative health care. A lot of their work is targeted at researching women’s sexual health. The twelve years following, many experts have tried to find causes for Female Sexual Dysfunction (FSD) and targeted therapy to treat the problem.

Unfortunately, previous treatments have been found relatively ineffective as female libido is commonly linked to psychological issues and not merely physical factors.

Emotional Brain believes they may have created something to beat the problem through two-in-one pills that will target both the body and brain.

The pills will be sized smaller than a typical aspirin and Lybrido will be comprised of a Viagra-like drug coated in a testosterone and will have a minty taste. Both components may be weak to combat low libido separately, but the testosterone-coating that melts in the mouth followed by a delayed-release of the Viagra-type substance.

Lyrbridos however will have its Viagra-like molecule replaced buspirone; an anti-anxiety medication that increases levels of the hormone serotonin. Unlike Viagra, Lybridos targets brain areas associated with sexual desire, encouraging the brain to realign with intimacy.

U.S. trials have finished involving more than 200 women have recently been completed, and Emotional Brain founder Adriaan Tuiten states the results from both drugs are ‘very, very promising’.
Dr Tuiten was prompted to research into female emotions after having his heart broken by an ex-girlfriend whilst he was in his 20s. It is his belief that the treatments will be a massive hit especially amongst women who have been married for many years and for whom sex may have lost the appeal and become stale over time.

Dr Tuiten says up to 43% of women experience a low sex drive at some point in their lives and has alleviated fears that the new drugs wills turn women into sex-crazed nymphomaniacs, stating that the treatments will work at simply increasing low-libido to more ‘normal’ levels.

Stigma hits hopes for female Viagra

Society and cultural barriers will continue to prevent women from recognising that they may suffer from female sexual dysfunction and seeking help, according to a new report.

Furthermore, the analysis, published by Datamonitor, notes that the non life-threatening nature of the disorders means that FSD “is often disregarded by the medical community”. FSD is an umbrella term that covers a variety of different dproblems from hypoactive sexual desire disorder (or low libido) and sexual arousal disorder to painful intercourse. Also there is often an overlap between disorders that can affect diagnosis and treatment.

Maya Marescotti, women’s health analyst at Datamonitor, says there is “a stigma associated with talking about sex, cultural embarrassment, and avoidance of discussion of sexual dysfunction in the clinical environment”. She adds that “these are common barriers that prevent doctors and patients from talking about sex”.

In a recent US study of 198 healthcare providers, only 34% of physicians would discuss sexual health with their patients on their own initiative. An earlier study across the pond showed that 75% of women would rather not discuss the subject as they thought the doctor would not be interested.

There is only one FSD drug available in the UK, where over 10 million women are thought to suffer from sexual dysfunction in their lifetime. That is Procter & Gamble’s Intrinsa, a testosterone skin patch which is given to women who have had their uterus and/or ovaries removed. New therapies are on the way, however, some of which target the psychological aspect of FSD, including Boehringer Ingelheim’s flibanserin, an oral pill originally developed as an antidepressant.

However, Ms Marescotti notes that “those hoping for a ‘female Viagra’ will be disappointed. In contrast to erectile dysfunction, she adds that “the complicated nature of FSD means that a quick fix in the form of an effective pill is very hard to achieve”