The strong placebo effect seen in Futura Medical’s phase III trial in erectile dysfunction has not deterred the company, but has instead encouraged it to seek approval for its medical device delivering the placebo rather than the drug as originally intended.
Based in Surrey, UK, Futura Medical is developing a medical device used to deliver drugs through the skin. The device was being tested in a phase III trial as a method to deliver a vasodilator drug with the intention of treating erectile dysfunction with a much faster onset and fewer side effects than currently available options.
The treatment resulted in a meaningful improvement for the participants in more than 60% of the cases, without any serious side effects. In addition, over 60% of them saw an effect within 10 minutes, whereas drugs such as Viagra have an average onset time of around 30 minutes.
However, when the device was used to deliver a placebo with the same formulation but no drug, it proved equally effective.
Rather than a failure, Futura Medical has seen an opportunity in these results. The company has stated that the study provides strong clinical proof to seek approval for the medical device without including the vasodilator drug. This could make the regulatory process simpler and faster, and make the treatment suitable for people that cannot take this drug.
Futura Medical has thus decided to file a new patent application expecting to extend the protection of the device until 2039.
The company has had a complicated past, with major players such as Durex and GSK having walked out of past deals. Now, the success of its treatment for erectile dysfunction might be essential for the company to be able to secure the necessary funding to keep going forward.
“Sometimes science gives you unexpected results but creates new opportunities,” said Ken James, Head of R&D at Futura Medical, during a webcast held this morning.