Futura Medical says it may have found simpler route to regulatory approval after surprise phase III results
These were nuanced results. For while MED2005 showed strong efficacy, excellent safety, rapid speed of onset, the placebo had a “highly statistically significant” impact on the men in the control group of the experiment.
Normally, a placebo is a sugar pill, liquid or gel with no medical benefit whatsoever.
However, in the Futura FM57 clinical assessment, researchers used DermaSys, developed by the company to deliver the active ingredient glyceryl trinitrate, or GTN for short.
As Futura said the results from the control group were highly statistically significant this would tend to rule out a small lift one sometimes sees called the placebo effect.
The outcome meant that while MED2005 scored well on most trial elements – for example, efficacy, safety, and speed of onset – it failed to meet its clinical endpoint against the placebo gel.
Chief executive James Barder said: "While we are surprised that FM57 has not met the primary endpoints versus placebo, we are excited that DermaSys alone has achieved such statistical significance in meeting all the primary endpoints against the baseline and key secondary endpoints using validated and globally accepted measurement tools.
“We now believe this supports the potential for a simpler route to regulatory approval for the proprietary DermaSys formulation as a clinically proven treatment for erectile dysfunction."
The drug is being developed for men with erectile dysfunction that cant take the current crop of blue pills because of their side effects.