A gel expected to become the world’s first over-thecounter medication for erectile dysfunction was announced yesterday to a clamour of excitement from pharmaceutical executives and claims of a new sexual revolution.

The non-prescription treatment, which would be available from pharmacies and supermarkets, will bring anti-impotence treatments into the consumer mainstream as never before if it passes clinical trials.

The gel, codenamed MED2002, is being developed by Futura Medical in collaboration with GlaxoSmithKline and is designed to be applied directly to the penis. If successful, it will go into direct competition with lucrative drugs such as Viagra, Pfizer’s famous little blue pill, in the multibillion-pound anti-impotence market.

The product is based on glyceryl trinitrate, or GTN, a vasodilator that has been used for the treatment of angina for more than 40 years. Viagra was also originally developed as a heart drug but during clinical trials it was found to have interesting side-effects. Since it was introduced in 1998, it has been prescribed to more than 23 million men.

Viagra’s success also generated a grey market of counterfeit products to satisfy the huge demand for impotence treatment from men unwilling to attend a GP’s surgery. Such potentially embarrassing face-to-face consultations are avoided with non-prescription medicines, which backers of MED2002 see as key to gaining a significant market share.

About 1,500 men are expected to be recruited into three clinical studies of MED2002, the first of which will begin before the end of this year. The goal is to have collected enough data on the safety and effectiveness of the gel for it to be filed for regulatory approval in 2008, with the clinical development programme expected to cost about £3.65 million.

As well as monitoring the use of MED2002 on male users, the trials will also involve the study of its effects on women, who will come into contact with the gel during sex.

The deal signed yesterday between Futura, a small British sexual health specialist, and GSK will also offer the pharmaceutical giant two first-refusal rights on two other products in early-stage development — a non-prescription treatment for female sexual dysfunction and a treatment for premature ejaculation.

James Barder, the chief executive of Futura, said yesterday that MED2002 could be in the shops within three years, having already proved its efficacy in initial trials.

A name for the product has yet to be decided but it will be priced at the level of other over-the-counter medicines, such as cold remedies.

Mr Barder would not be drawn on the potential profits, but pointed to a potential market of 152 million men who suffer from mild or moderate impotence, a number that is expected to double by 2025.

“Only one in five impotent men will go and see a doctor,” Mr Barder said. He described the gel as being intrinsically safer than Viagra because it is applied topically rather than taken in the form of a pill, which is ingested.

The gel works in a similar way to prescription treatments for erectile dysfunction, causing dilation of the arteries and increased blood flow.

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