Female Viagra drug Flibanserin on the cusp of FDA approval

female viagraSince 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.

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