US panel rejects 'female Viagra'

An advisory panel for the US Food and Drug Administration Friday voted unanimously against approving a pill that helps boost women's sex drive, described by some as the "female Viagra."

The FDA's Reproductive Health Drugs Advisory Committee said the evidence presented had not demonstrated the effectiveness or safety of flibanserin, made by the German company Boehringer Ingelhein.

"The efficacy was not sufficiently robust to justify the risks," said panel chair Julia Johnson, chief of obstetrics and gynecology at the University of Massachusetts Medical School, after the committee's deliberations.

The FDA usually follows these panels' advice, even though it is not required to do so by law.

Flibanserin, the latest effort to come up with a female counterpart to the wildly popular male erectile dysfunction pill Viagra, works on brain chemicals to treat pre-menopausal women with a low sex drive, according to the maker.

To date, the drug known by the commercial name Girosa has not been approved for sale in any country, in contrast to treatments for male sexual dysfunction.

Pharmaceutical firms have vied for a spot in this potential market estimated to be worth two billion dollars since Viagra was launched in 1998 becoming a huge success, and was subsequently followed by competitors Cialis and Levitra.

Several medical trials, including a study published in the New England Journal of Medicine, say that at least 40 percent of women suffer from varying degrees of sexual hypoactivity, though critics warn that big pharma has funded a number of these surveys.

An analysis of the two clinical trials published on the FDA's website note that both "failed to demonstrate a statistically significant improvement" in sexual desire, even though patients who took flibanserin had slightly more satisfying sexual relations with their partners than those who took a placebo.

"Neither study met the agreed-upon criteria for success in establishing the efficacy of flibanserin for the treatment of HSDD" (Hypoactive Sexual Desire Disorder), the report added.

The two-year studies, measured by women's diary entries in the United States and Canada, found that women who took flibanserin reported an average 4.5 more satisfying sexual experiences per month, versus 3.7 for those who took a placebo.

The women - most of them married with a high education and good health apart from their decreased libido - had reported an average 2.8 satisfying experiences before taking the medicine.

According to the studies cited by FDA, flibanserin can also cause side effects such as depression or dizziness.

Flibanserin belongs to a family of anti-depressants that reduce the level of serotonin, which has an effect on mood and can put a damper on sexual desire.

The drug also controls the levels of dopamine and norepinephrine in the blood, substances that act on sexual desire, the pill's manufacturer said.

js/oh/rl/jkb

 

Life and Style
ebookNow available in paperback
ebooks
ebookA delicious collection of 50 meaty main courses
Latest stories from i100
Have you tried new the Independent Digital Edition apps?
SPONSORED FEATURES

ES Rentals

    Independent Dating
    and  

    By clicking 'Search' you
    are agreeing to our
    Terms of Use.

    iJobs Job Widget
    iJobs General

    Recruitment Genius: Senior Environmental Adviser - Maternity Cover

    £37040 - £43600 per annum: Recruitment Genius: The UK's export credit agency a...

    Recruitment Genius: CBM & Lubrication Technician

    £25000 - £27500 per annum: Recruitment Genius: This company provides a compreh...

    Recruitment Genius: Care Worker - Residential Emergency Service

    £16800 - £19500 per annum: Recruitment Genius: Would you like to join an organ...

    Recruitment Genius: Senior Landscaper

    £25000 - £28000 per annum: Recruitment Genius: In the last five years this com...

    Day In a Page

    Refugee crisis: David Cameron lowered the flag for the dead king of Saudi Arabia - will he do the same honour for little Aylan Kurdi?

    Cameron lowered the flag for the dead king of Saudi Arabia...

    But will he do the same honour for little Aylan Kurdi, asks Robert Fisk
    Our leaders lack courage in this refugee crisis. We are shamed by our European neighbours

    Our leaders lack courage in this refugee crisis. We are shamed by our European neighbours

    Humanity must be at the heart of politics, says Jeremy Corbyn
    Joe Biden's 'tease tour': Could the US Vice-President be testing the water for a presidential run?

    Joe Biden's 'tease tour'

    Could the US Vice-President be testing the water for a presidential run?
    Britain's 24-hour culture: With the 'leisured society' a distant dream we're working longer and less regular hours than ever

    Britain's 24-hour culture

    With the 'leisured society' a distant dream we're working longer and less regular hours than ever
    Diplomacy board game: Treachery is the way to win - which makes it just like the real thing

    The addictive nature of Diplomacy

    Bullying, betrayal, aggression – it may be just a board game, but the family that plays Diplomacy may never look at each other in the same way again
    Lady Chatterley's Lover: Racy underwear for fans of DH Lawrence's equally racy tome

    Fashion: Ooh, Lady Chatterley!

    Take inspiration from DH Lawrence's racy tome with equally racy underwear
    8 best children's clocks

    Tick-tock: 8 best children's clocks

    Whether you’re teaching them to tell the time or putting the finishing touches to a nursery, there’s a ticker for that
    Charlie Austin: Queens Park Rangers striker says ‘If the move is not right, I’m not going’

    Charlie Austin: ‘If the move is not right, I’m not going’

    After hitting 18 goals in the Premier League last season, the QPR striker was the great non-deal of transfer deadline day. But he says he'd preferred another shot at promotion
    Isis profits from destruction of antiquities by selling relics to dealers - and then blowing up the buildings they come from to conceal the evidence of looting

    How Isis profits from destruction of antiquities

    Robert Fisk on the terrorist group's manipulation of the market to increase the price of artefacts
    Labour leadership: Andy Burnham urges Jeremy Corbyn voters to think again in last-minute plea

    'If we lose touch we’ll end up with two decades of the Tories'

    In an exclusive interview, Andy Burnham urges Jeremy Corbyn voters to think again in last-minute plea
    Tunisia fears its Arab Spring could be reversed as the new regime becomes as intolerant of dissent as its predecessor

    The Arab Spring reversed

    Tunisian protesters fear that a new law will whitewash corrupt businessmen and officials, but they are finding that the new regime is becoming as intolerant of dissent as its predecessor
    King Arthur: Legendary figure was real and lived most of his life in Strathclyde, academic claims

    Academic claims King Arthur was real - and reveals where he lived

    Dr Andrew Breeze says the legendary figure did exist – but was a general, not a king
    Who is Oliver Bonas and how has he captured middle-class hearts?

    Who is Oliver Bonas?

    It's the first high-street store to pay its staff the living wage, and it saw out the recession in style
    Earth has 'lost more than half its trees' since humans first started cutting them down

    Axe-wielding Man fells half the world’s trees – leaving us just 422 each

    However, the number of trees may be eight times higher than previously thought
    60 years of Scalextric: Model cars are now stuffed with as much tech as real ones

    60 years of Scalextric

    Model cars are now stuffed with as much tech as real ones