‘Female Viagra’ Addyi (Flibanserin) hits the American market

American women rejoiced on Saturday 17^th October after the commonly touted ‘female Viagra’ finally launched in the United States.

Addyi (known generically as Flibanserin) finally received the required approval from the Food and Drug Authority (FDA) on 18 August, albeit reluctantly, with the little pink pill previously facing two rejections on account of concerns about just how effective it was and any potential side effects – especially when alcohol is consumed.

The FDA have strongly warned that women should never drink alcohol while taking Addyi as the risk of fainting is high. This also poses a higher risk for drivers.

However, women that have lost their sexual desire can now go to their doctor and ask for Addyi (it is available on prescription only), and should find that they will be quizzed about their current method of birth control, prescribed medications, relationship with their partner, as well as if they have previously suffered from depression or other mental health problems.

The National Institute of Health claim that around 40% of women in America suffer from female sexual dysfunction, but Addyi is targeted at the estimated 10% of premenopausal women – around 16 million American women – who suffer from hypoactive sexual desire disorder (HSDD). HSDD is characterised as a constant lack of sexual thoughts and interest in sexual activity, resulting in a state of distress and cannot be explained by another medical condition or substance, such as anxiety or relationship issues.

Addyi becomes the first pill-based treatment of any type of low sexual desire, and many women will be unaware it has launched. Moreover, American women will not be inundated with advertisements on television, radio, print or digital advertising for at least 18 months.

The drug’s manufacturer’s – Sprout Pharmaceuticals - has agreed to forgo all paid advertising for more than a year to slightly ease the FDA’s worries about Addyi’s safety.

The promise to FDA will not prevent Sprout from promoting Addyi via various other popular mediums, with Sprout’s eagerness to engage with women through social media, in addition to holding interviews with media outlets and other influential organisations, demonstrating a new way forward for pharmaceutical marketing strategy.

“I think what they’re doing is pretty clever, actually,” Dan Leinweber, president at a boutique PR firm called Leinweber Associates, said. “This is a much less costly way to get their word out in a much more credible way.”

Widely popular erectile dysfunction treatment Viagra also happened to be a completely new treatment within a new class of sexual medicine upon its introduction to the world back in 1998. In the subsequent 17 years, ‘the little blue pill’ Viagra has easily become one of the most heavily advertised drugs in the world, bringing in massive amounts of profit for its maker Pfizer. An incredible $232 million was spent on advertising Viagra by Pfizer in 2014, and Viagra brought in a record $2 billion in revenue in 2012.

Thus far, it remains to be seen if Sprout will begin to look at the UK and other European countries for a release of Addyi, with no word yet on their future plans for the drug. Before any drug is sold in Britain though, it has to receive a license from the European Medicines Agency. Keep checking the Medical Specialists® Pharmacy website for further updates.

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.

Boehringer stops Female Viagra drug After FDA's Safety report

Boehringer Ingelheim GmbH abandoned development of its female Viagra like drug “flibanserin” after the FDA said the pill wasn’t proven to be safe and effective enough to be given to the public.

Boehringer is still convinced flibanserin would have helped women, Chief Executive OfficerAndreas Barner said in an e- mailed statement today. “The decision was not made lightly, considering the advanced stage of development,” he said.

Flibanserin showed promise a year ago with late-stage test results indicating women who took it wanted -- and had -- more sex. Questions arose later about whether its effect was big enough to outweigh potential side effects, including depression, anxiety and fatigue. The FDA panel voted unanimously in June against backing the drug after a review.

The decision by Boehringer, based in the German town of Ingelheim, is the latest in a series of failures by drugmakers to influence women’s libidos. Pfizer Inc. abandoned efforts to adapt Viagra for women in 2004, while Procter & Gamble Co. failed to win regulators’ backing for a testosterone patch.

Libido drugs for women may create an annual market of at least $2 billion, BioSante Pharmaceuticals Inc. has estimated.

Boehringer, the world’s biggest family-owned drugmaker, had said flibanserin would drive growth as its prostate drug Flomax and Parkinson’s therapy Mirapex lose patent protection.

The drugmaker said it will still complete the two most advanced patient studies under way with flibanserin, while other research resources will be reallocated to stroke prevention, diabetes and oncology.

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”