Chance for women to patch up sex lives

Published on Sunday 16 January 2005 00:09

A FEMALE version of Viagra, designed to boost women’s sex drive, could shortly be available on prescription in the UK, Scotland on Sunday can reveal.

The testosterone patches are designed to treat women who suffer a flagging libido following the menopause. But - like Viagra - many suspect they will be used for recreational, rather than purely medical purposes.

The maker of Intrinsa, Procter & Gamble, has applied for a licence to market the product throughout Europe. But a similar bid in the United States is on hold amid health concerns about the long-term use of the patches.

The Scottish Medicines Consortium, which recommends drugs for use by the NHS in Scotland, has confirmed that it will now consider whether GPs should prescribe Intrinsa.

The drug works in a similar way to nicotine patches used to help wean smokers off cigarettes. Women wear the patch on their abdomen, where it gradually releases a dose of testosterone into the body through the skin. Although testosterone is a male hormone, women produce it naturally and it is believed to be involved in boosting sexual appetite.

Procter & Gamble has applied to the European Medicines Agency (EMEA) - one of two agencies that can regulate drugs in the UK - to have Intrinsa licensed for prescription. "It will be a drug we will be looking at when it comes through the licensing process," said a spokeswoman for the Scottish Medicines Consortium.

If passed, the patch could be available on prescription through the NHS in Scotland within two years.

But a similar bid to have the patch passed in the US has stumbled after the Food and Drugs Administration (FDA) voted against recommending Intrinsa for approval. It called for more studies into the patch’s long-term safety, echoing concerns raised by doctors.

Women given the female hormone oestrogen in hormone replacement therapy are known to suffer a greater risk of stroke, cancer and heart disease.

Doctors fear this could also be the case with testosterone replacement.

"At the moment this is of unproven benefit and the risks involved will not become clear until 10 years of prescribing down the line," said Dr Richard Anderson, a consultant in reproductive medicine with the Medical Research Council’s human reproductive unit.

Intrinsa is the first in a number of testosterone treatments being developed for women, with another product called LibiGel from US drug firm Antares Pharmaceuticals also being produced.

The companies estimate the market for such products could be in excess of 2bn, following Viagra as one of the fastest-selling drugs in history.

Officially the drugs are purely for treating women who have gone through the menopause or had a hysterectomy. But doctors fear they could also be marketed at women who purely wish to spice up their sex lives.

Procter & Gamble claims its patch "significantly increased satisfying sexual activity and desire" in women with a condition known as Hypoactive Sexual Desire Disorder (HSDD) where their lack of sexual desire causes personal distress. The company said a study it carried out showed patients receiving the patch experienced an increase in sexual activity, arousal and pleasure.

A spokesman for Procter & Gamble said: "We have submitted an application to the EMEA but cannot give details of when this will result in a filing.

"The decision by the FDA does not affect the status of the Intrinsa European filings for the treatment of HSDD in surgically menopausal women, and we are proceeding with it as planned."

Testosterone is already given to men in high-dose gels to treat hormone deficiencies, and in some cases these have been prescribed to post-menopausal women. Experts fear this could cause major health problems and insist giving extra testosterone to women also has more immediate side effects.

Over a period of time, excessive testosterone in women can lead to facial hair growth, deepening of the voice and other signs of masculinity.

The patch has also met criticism from sexual health therapists, who believe drug companies are creating a profitable medical ‘cure’ for a disorder in women that is often down to psychological problems.

Dr Lindsey Myskow, lead clinician at the Edinburgh Royal Infirmary’s sexual health clinic, is sceptical about the patch’s uses.

"In post-menopausal women, testosterone patches can be very helpful," she said. "In cases like that they often have an absent sex drive and some cannot bear to be touched or cuddled. Adding testosterone changes things back to normal. But in women who simply suffer from low libido, they are of no use and I just don’t think it will work.

"Sex drive is such a complex thing and has as much to do with how a woman is feeling about herself and her partner as low levels of hormones."

A spokeswoman for the EMEA refused to comment on the progress of the Intrinsa licence application.

But Anderson warned the effect of the patch appeared to be minimal and the agency may follow its US counterparts by demanding further studies into the drug. He said: "It is quite a contentious issue.

"There is an impression the actual condition they are talking about is one that has been spun up by the company as it has a drug to market."