Futura looking good

Following the completion of Futura's Phase II double-blind, placebo controlled, escalating-dose ranging study, of its treatment for erectile dysfunction, Eroxon, the company reported a good safety profile for the product.

The systemic adverse events, which were mostly mild and moderate headaches in some subjects, were in line with expectations and suggested a dose-related response.

A secondary objective of the study was to determine if a dose related efficacy response could be seen. Analysis is still ongoing and, although some dose related trends against placebo were seen, these trends did not achieve statistical significance.

This was in part due to the large degree of inter and intra subject variability, taken together with an unexpectedly high placebo response of nearly 60% and the limited size of the study.

All ED studies show a significant placebo response, typically 30%, which is partly attributed to the psychogenic issues surrounding ED sufferers. The mode of application of Eroxon (a cream being massaged directly onto the glans of the penis versus taking a pill) is thought to have contributed to this unexpectedly high placebo effect.

In light of these trials Futura is seeking to license the product as an otc product rather than a prescription only medicine within the EU.

'ED is understandably considered an embarrassing condition, although the publicity surrounding the launch and promotion of Viagra and more recently Levitra has increased public awareness and acceptability of ED. Nevertheless it is widely recognised that only around one in five men will go to his GP to seek treatment for ED.

'We believe that Eroxon, as potentially the first ethical otc treatment within the EU, will considerably help address the embarrassment problem faced by many ED sufferers It could also have the added advantage of removing the issues facing many governments over the state funding of what is considered by some to be 'lifestyle' medication,' said ceo James Bader.