The only way is up

Men don't want to talk about it, but erectile dysfunction is a major problem as it affects nearly 170m of us. Futura Medical, a UK company, has developed a topical product to combat the condition.

By 2004 there will be an estimated 169m impotent males for the global erectile dysfunction (ED) market to tap into. There are many reasons for the problem (table 1), and it will be a market worth US$1.32bn (€1.19bn) to companies supplying treatments. Some 86m men suffering ED are in the key pharmaceutical markets, which includes 7.2m males in the UK, and 70m in the US.

Treatments include drugs, vacuum technologies, and surgery (table 2). On the drugs side there are a number of alternatives including:

•Oral tablets such as Pfizer's Viagra (sildenafil);

•Intracavernous injections e.g. Pharmacia's Caverjet (alprostadil) or

•Intraurethral pellets e.g. Muse (alprostadil) from Vivus.

There are obvious problems with most of these, in that they have side effects, are painful to use, or they take a while to start working. One alternative would be a rub-on product. Currently, there are no topical products available on the market, although a couple of companies are developing alprostadil-based products.

Futura Medical was set up with the aim of developing innovative products for the treatment of sexual dysfunction. Based at Surrey Research Park in Guildford, UK, it is developing four products for the treatment of both male and female sexual dysfunction. The first product is a cream, based on the well characterised active glyceryl trinitrate (GTN), which is topically applied to the penis for the treatment of ED, see figure 1.

MED2001 offers a non-invasive alternative to current oral and injectable therapies. One key benefit is that it can potentially be used by chronic nitrate users for whom sildenafil (Viagra) and any other PDE5 (phosphodiesterase enzyme) inhibitors are contraindicated because they may lead to problems of abnormally low blood pressure.

GTN is a potent vasodilator that improves penile blood flow, thereby increasing the rigidity and duration of a naturally occurring erection. 'One advantage of a topically applied product is that it is much more consistent with foreplay, it is rapidly absorbed, and you don't have to wait an hour for it to work,' commented David Davies, product development manager for Futura.

Another advantage is that such a treatment is less invasive, which is welcomed not only by the user, but also by urologists for clinical reasons.

UK Phase I and II clinical trials of the product have been conducted, and the results show that GTN is well tolerated and safe with good efficacy.

The pharmacokinetic profile achieved rapid absorption, rapid elimination, and there was some pooling within the corpus cavernosa. Phase IIb trials have commenced in Mexico, with European Phase III trials due to start in the second quarter of this year, and expected submission to the EU in early 2004. James Barder, ceo of the company, said Futura hoped eventually to sell the product over the counter. 'Selling the product otc would also reduce the embarrassment factor ; something like 85% of men don't report it because they are embarrassed ; especially if the problem is mild or moderate.' He continued: 'Licensing MED2001 to the major pharmaceutical manufacturers is the quickest way to bring our GTN technology to the global erectile dysfunction market, including for angina sufferers. Negotiations are ongoing with a number of global pharmaceutical companies.'

Of the other products in-house, using a low dose formulation of GTN in a condom to help maintain an erection is probably closest to market. 'About 160m condoms slip off each year during intercourse caused by the man losing a firm erection, so by putting a small active dose into the condom, we can maintain an erection for longer,' said Barder. This has advantages in preventing unwanted pregnancies and reducing STDs (Sexually Transmitted Diseases).

Futura is also developing products for female sexual dysfunction (FSD), see below, and premature ejaculation (PE). 'They are different markets: PE is predominantly a young men's market, related to performance anxieties, while FSD is considered much more complex than ED,' Barder concluded.