The erectile dysfunction drug market is shaped by the parallel needs of consumers and industry, with both demanding faster and more reliable performance. Maxine Vaccine explores the fine line between medicine and desire.

This week’s most exciting drug news was the FDA approval for Stendra (avanfil) from Vivus: an erectile dysfunction drug that can take full effect within 15 minutes.

Stendra is the youngest and studliest member of the Viagra family (PDE5 inhibitors), all of which have generic names ending in ‘fil’. Whether that is a play on ‘phile’ (lover) or, more crudely, on ‘fill’ is a question for chemists. It definitely has nothing to do with Phil Mitchell.

The greater speed of action of Stendra prompted urologist Dr Ira Sharlip to make the slightly double-edged comment: “Quick onset of action is important to men.” He added that Stendra would appeal predominantly to ED sufferers “whose opportunities for sexual activity are more casual”.

The new kid in town has the classic side-effects of the PDE5 inhibitor family: headache, lack of sensation, insomnia. But it doesn’t have the rare side-effect observed with Viagra of blue-tinged vision – about which Dr Sharlip said:

“Blue vision with Viagra is uncommon and at worst annoying. Most men who get the blue vision with Viagra don’t care about it.”

Perhaps it just reinforces their sense of living in a blue movie.

But is the impatience of male patients to get it on resonating with the sales professional’s hard-on for the next customer – leaving the clinician as the odd one out in the commercial three-way?

Let’s be honest about this. ED drugs restore reliable sexual functionality to men in whom age and/or circulatory problems have made such functionality unreliable or impossible. They are clinically suitable for men who are in late middle age or old age or have certain medical conditions.

They are not clinically suitable for young and healthy men who want to have more sex for longer, to have sex while drunk or stoned, or to be able to make porn films or imagine they are doing so. Yet that is the natural ‘market’ driven by their brand positioning as performance-enhancing products rather than as medicines helping to restore normality.

The ambiguity of the Viagra brand – is it a medical product or a consumer sex aid? – is reflected in the online market that exists for stolen pills or counterfeit versions of the drug. Just how big is that market? Well, this week it was reported that British fraudster Martin Hickman has been ordered to pay back £14.4 million earned by selling fake Viagra online.

The investigation – one of the biggest ever undertaken by the MHRA – uncovered more than 30 bank accounts scattered around the world, with customers across Europe served via a website hosted in Germany but run by Hickman from his Staffordshire home.

The pharmaceutical industry makes no money from counterfeit drugs – and indeed, it loses custom since those customers will not seek prescriptions. But the question the industry has to ask itself is: does its brand positioning create images and expectations that help to drive a black market in fake drugs?

Remember: a sales rep can do it all night, but only a key account manager can make your breakfast in the morning.

Maxine’s views are not necessarily those of Pharmaceutical Field.

A new, more rapid-acting erectile dysfunction (ED) drug that is currently being assessed by the EMA has gained FDA approval.

Stendra (avanafil) from Vivus can take effect within 15 minutes, phase 3 clinical trials with over 1350 patients have shown.

The newest addition to the class of ED drugs that includes Viagra, Levitra and Cialis, Stendra is targeted more at patients who engage in casual sex.

The FDA approval is the first gained by US company Vivus, which has licensed the US marketing rights to Stendra from Mitsubishi Tanabe Pharma of Japan.

Stendra will be available in three doses, all of which have been shown to provide statistically significant improvements in erectile and sexual function.

Like other phosphodiesterase type 5 (PDE5) inhibitors, Stendra improves penile blood flow – but it offers a faster action than its rivals.

The drug’s side-effects are characteristic of PDE5 inhibitors: headache, flushing and cold symptoms. However, Stendra clears the body more rapidly than other drugs in its class.

Dr. Ira Sharlip, Professor of Urology UC San Francisco, commented: “Quick onset of action is important to men.” He noted that Stendra was likely to appeal most to ED sufferers “whose opportunities for sexual activity are more casual”.

A marketing authorisation application for Stendra was accepted by the European Medicines Agency (EMA) on March 26.
“The unique profile of avanafil, including its onset of action and highly selective profile, make it an attractive treatment alternative for the more than 20 million European men suffering with ED,” said Francesco Montorsi, Director of the Urology Research Institute in Milan, Italy.

“The comprehensive results from the development program suggest avanafil, if approved, could effectively compete in the $4 billion worldwide ED market.”