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.

ED drug Cialis helps ejaculation and orgasm problems too

The findings of a new U.S. based study published within the February edition of the British Journal of Urology International suggests that the wonder erectile dysfunction medication (ED) Cialis may provide use to men in other areas of sexual dysfunction besides the obvious one of helping them to achieve and maintain an erection.

According to those behind the study, non-erectile sexual dysfunction issues are often both underreported and undertreated compared to ED possible due to a social stigma involved in addition to confusion about the physiology of male sexual response and orgasmic dysfunction, but problems reaching an orgasm and ejaculating are actually more common that people realise.

‘The Weekend Pill’ Cialis is one of three main ED medications together with Viagra and Levitra, rapidly becoming popular with millions of men after stepping out of large shadow cast by Viagra purely because it was released before Cialis and Levitra.

In recent times as clinical trials have taken place exploring the massive potential of Cialis, it has received European approval to be prescribed to men suffering with both ED and benign prostatic hyperplasia (BPH); a condition that mainly affects older men that results in an enlarged prostate gland and problems including difficulty passing urine, a need to urinate frequently, or finding it difficult to completely empty the bladder.

Researchers from NewYork-Presbyterian Hospital/Weill Cornell Medical Center, led by Dr. Darius Paduch, opted for a meta-analysis statistical analysis – examining data extracted from 17 different placebo-controlled clinical trials that included a total of 3,581 participants, with a mean age of 54.9. Only some of the patients had reported as having mild or moderate ED.

In total, it was calculated that 1,512 of the men were suffering with severe ejaculatory dysfunction (EJD) and 1,812 had severe orgasmic dysfunction (OD) – two closely linked conditions but slightly different in that men with EJD experience an inability to achieve ejaculation during sexual activity, despite the male wanting to and still having an erection. OD is also referred to as ‘Anorgasmia’, whereby there is a loss of ability to have an orgasm which could be connected to factors such as certain medications, illness, depression, alcoholism or pelvic surgery. ‘Primary anorgasmia’ sufferers however have never achieved an orgasm despite sexual activity, but this is more prevalent in women.

The researchers looked at the men’s response to questions about what (if any) impact that Cialis had on ED, EJD, and OD, among other measures of sexual satisfaction. The questionnaire was tailored more towards ED and how Cialis improved this, but the comments given by the participants were intriguing and showed that Cialis could be used in other areas of sexual dysfunction too.

After a meta-analysis of the clinical trials, it was found that 66% of men who had severe EJD and 66% with severe OD who took Cialis prior to sexual activity over 12 weeks reported improved ejaculatory function, compared to just 36% and 35%, respectively, in the group assigned the placebo. Interestingly, benefits from Cialis were evident regardless of severity of the man’s ED.

Speaking in a press release, Dr Paduch said: “There are many men who have, at most, very mild problems achieving an erection but who cannot easily ejaculate. Our study shows Cialis works very well for these men with problems ejaculating. Many of my patients are young men who want to have children and so they want to solve their issues with ejaculation. We don’t know why this occurs. Every internist faces this problem in his male patients and has no options to offer. Our study shows Cialis may help.”