Vyleesi: latest attempt at 'female Viagra' approved by US regulators

Pharmaceutical known chemically as bremelanotide is aimed at women with low sexual desire disorder or HSDD

Guardian Staff and agencies 

 

An auto-injector for Vyleesi, chemically known as bremelanotide. Photograph: AP


Drug regulators in the United States have approved Vyleesi, the latest attempt to come up with a “female Viagra” for women with low sexual desire.

Vyleesi, chemically known as bremelanotide, is said to activate pathways in the brain involved in sexual desire, helping premenopausal women with hypoactive sexual desire disorder (HSDD). It has been developed by Palatin Technologies and licensed to Amag Pharmaceuticals, and is expected to be available from September through select pharmacies.

The drug will compete with Sprout Pharmaceuticals’ Addyi, a once-daily pill that was approved for HSDD in 2015 with a warning restricting alcohol use when on the medication. Addyi was approved under intense pressure from advocacy groups despite a review by scientists at the Food and Drug Administration (FDA) that deemed it minimally effective and possibly unsafe.

Vyleesi, which does not restrict alcohol use, is seen as having several advantages over Addyi including tolerable side effects, rapid-acting nature and not having to be taken every day, according to analysts.

The drug is administered as a shot into the abdomen or thigh using an auto-injector at least 45 minutes before anticipated sexual activity, with the FDA recommending patients not to take more than one dose within 24 hours or more than eight doses per month.

Side effects reported during clinical trials included mild to moderate nausea lasting no more than two hours and mostly occurred over the first three doses, Amag said. About 40% of patients in clinical trials experienced nausea.

The drug was developed by Palatin, and Amag holds exclusive North America sales rights. Palatin will get $60m from Amag for the approval plus additional payments for certain sales milestones and royalties.

Analysts have said that a drug that safely and effectively treats loss of sexual desire in women could eventually reach annual sales of about $1 billion.

Hope for mature women?

'Female Viagra' approved by US drug agency 

• From the sectionBBC News

Experts have said the effects of the libido-enhancing drug are "modest"

The US Food and Drug Administration (FDA) has approved a libido-enhancing drug for women that has been dubbed "Female Viagra".

Flibanserin, a drug produced by Sprout Pharmaceuticals, recently passed an FDA advisory committee meeting.

The pill is designed to assist premenopausal women regain their sex drive by boosting levels of certain brain chemicals.

The drug has been criticised as having marginal effects.

Versions of the pill, which will be marketed as "Addyi", have been submitted for approval in the past but never passed.

It was rejected by the FDA twice for lack of effectiveness and side effects like nausea, dizziness and fainting.

Women taking the drug reported between half and one more sexually satisfying event per month - results experts admitted were "modest".

Originally the drug was produced by German company Boehringer Ingelheim. Sprout bought the drug from that company after it was turned down by the FDA.

Sprout CEO Cindy Whitehead gains approval for the first drug to boost sexual desire in women

Documents from the 4 June FDA advisory meeting describe the drug's purpose as "treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women".

Women would take it each night.

A doctor would have to determine whether a woman seeking the pill was suffering from a disorder characterised by a lack of sexual fantasies and desire, causing the woman distress.

Currently, there is nothing on the US market approved for treatment of HSDD or another condition, female sexual interest/arousal disorder (FSIAD).

"This condition is clearly an area of unmet medical need," the FDA documents said.

A brain-shaped stress ball at a Sprout employee's desk at their headquarters in Raleigh, North Carolina

Sprout only has 25 employees. Large pharmaceutical companies like Pfizer, Bayer and Proctor & Gamble have all studied female sexual desire disorder treatment but abandoned plans to pursue it.

Sprout's CEO, Cindy Whitehead, told AP they would promote Addyi carefully.

"We would never want a patient who's not going to see a benefit to take it and tell everyone it doesn't work," she said.

Lobbying by Sprout Pharmaceuticals was backed by the women's rights group Even the Score, which has accused the FDA of gender bias by approving a number of drugs treating erectile dysfunction in men without passing an equivalent for women.

Coming soon: invasion of the marauding nymphomaniacs

Thanks to 'female Viagra' and government regulation, we women can enjoy sex again – just hopefully not too much

• 
• • Naomi McAuliffe
  • guardian.co.uk, Monday 27 May 2013 17.18 BST

'People like sex. Sex is sexy.' Photograph: Jennifer Szymaszek/AP

We are standing on the brink of the breakdown of society. A world in which the economy grinds to a halt. Schools stand empty; there are no teachers left and the dinner ladies have found something better to do. Hospitals career towards crisis point as nurses become the uniformed sex-crazed bunnies that porn has long suspected them to be. This is the land of the marauding nymphomaniacs – hypersexed women who are hardly able to walk straight, never mind function as citizens.

This is the risk potentially posed by Lybrido, the female arousal drug (or "female Viagra"), according to some "experts" who are worried that this drug won't get past the regulators unless there are assurances that it won't lead to women becoming raptorial sex beasts. Women should like more sex, but not too much.

Of course this is another pharmaceutical attempt to cure social ills with a pill. A lower libido in both men and women may well have more to do with that screaming baby in the next room or the pending redundancy at work than anything physiological. But dealing with individuals' psychology or social circumstances is boring and hard and complex while pharmaceutical marketing is fun and easy and quick.

And this involves SEX. People like sex. Sex is sexy. Diarrhoea isn't sexy, lung disease isn't sexy and things that aren't sexy get less of our attention and investment. Female sexuality is even more dark and mysterious and feeds those odd social constructs that say women don't like sex as much as men do and therefore have to be "fixed", unless they do like sex as much as men do and so must be broken and are either mad, bad or wanton. Maybe women need a recommended daily fornication allowance.

Interestingly, the inspiration for the lady-horn enhancer was not a desire to create a louche legion of loose women, but came from one tragic man's way of getting over a broken heart. Dr Adrian Tuiten, head of the Dutch firm Emotional Brain, which developed the drug, was trying to understand why his long-term girlfriend dumped him in his 20s. Apparently "the breakup inspired a lifelong quest to comprehend female emotion through biochemistry and led to his career as a psychopharmacologist." (I'd suggest the desire to comprehend female emotion through biochemistry might actually be part of the reason for the break-up). The developers of this drug actually want it to promote monogamy, not instigate indiscriminate sex mania.

The trials completed so far on this drug have been exclusively with women in long-term, monogamous relationships where simply the spark has gone. However, increasingly evidence shows that for many women the cause of their sexual malaise appears to be monogamy itself. Evolutionary psychologists (or as I like to call them, Just So Story tellers) claim that it is innate biology that gives men a naturally higher sex drive. But ameta-analysis of studies by psychologists in 2010 shows little sex differences in the sexuality of men and women and where there were differences – such as rates of masturbation or pornography use – they were heavily influenced by culture and the gender equity of the social group studied.

It is almost impossible to separate female sexuality from culture. Depending on a variety of factors from the number of sexual partners you have had, how much flesh you show, whether you use contraception, how much you masturbate (because women do masturbate!), whether or not you "use" pornography (read it, watch it, look at it) and what kind of pornography it is ("it's a book, therefore erotica!") all variously determine whether you are a slut, whore, slag, prude, lesbian, harlot, prig or the veritable Mrs Grundy.

Society is as concerned by women who like sex as those who don't. Nymphomania was a form of mental illness or disease in the Victorian era with seemingly endless symptoms; masturbation, homosexuality, sexual dreams, or in one case the "lascivious leer of her eye and lips, the contortions of her mouth and tongue, the insanity of lust which disfigured [her]". This disease was variously "cured" with abstinence, vegetarianism, cold douches or more viciously with confinement to an asylum or even a form of female genital mutilation where the clitoris was removed.

The modern version is seemingly to attain that perfect balance between women enjoying sex more in their long-term, increasingly loveless, monogamous relationship through some kind of love potion and also resisting the ever-present lure of the strumpet within us. Only a heady combination of drugs, government regulation (through marriage, adultery laws, access to contraception) and overwhelming social pressures seem to be able to regulate female sexuality around the world. Who knows what would happen if we could discover and develop our own sexuality and properly understand how that changes and fluctuates over time and circumstance? Who knows what might have been achieved had people spent their energy on things other than regulating female sexuality? Perhaps everyone might be happier and hornier.

India's poster boy for vegetarianism – he's just fathered a child at 96

Andrew Buncombe in The Independent

The world's oldest father has been recruited by activists in India who maintain lifelong vegetarians retain their "vigour" better than others.

Ramajit Raghav, who shot to celebrity two years ago at the age of 94 when he first became a father, features in a new campaign by for People for the Ethical Treatment of Animals (Peta) India.

A photograph of Mr Raghav, who recently fathered his second child, Ranjit, at the age of 96, shows him cradling the baby with the headline "Vegetarians Still Got It at Age 96".

"I have been a vegetarian all my life, and I credit my stamina and virility to my diet," said the elderly father from the state of Haryana. "Being a vegetarian is the secret to my strength and good health."

Peta claims living a vegetarian life makes perfect sense and that India is increasingly seeing problems associated with heart disease, cancer and diabetes, which it says are associated with a meat-eating diet.

"And since each vegetarian saves the lives of more than 100 animals a year, their consciences are lighter, too," it said. "Viagra and other anti-impotence drugs may get you through the night, but a vegetarian diet can get you through your life. Numerous physicians agree that the best way to prevent artery blockage and other conditions that cause impotence is to eat a diet high in fibre, including plenty of fruits, vegetables, and whole grains."

When he was interviewed last month by The Times of India, Mr Raghav revealed he had been a bachelor until meeting his wife, Shakuntala Devi, ten years ago.

He has been a strict vegetarian and has never drank alcohol. Instead, his diet is made up of fresh milk, clarified butter, vegetables and chapattis.

"I wake up at five in the morning and go to bed before 8pm. During the day, I work in the fields and also take an afternoon nap," he said