Pharmaceutical company Futura Medical may be able to process its DermaSys technology through a medical devices regulatory path, following surprising results from the phase III clinical trial of its erectile dysfunction (ED) gel MED2005.
The company is working on developing a portfolio of products in the sexual health and pain management markets based on its transdermal DermaSys drug delivery technology. DermaSys enables targeted and rapid delivery of active pharmaceutical ingredients (APIs) through the skin to the required site of action.
In a phase III trial dubbed FM57, MED2005 showed strong efficacy, safety, speed of onset, and had a highly statistically significant impact on the participants in the control group of the experiment. Over 60% of participants saw onset within 10 minutes of applying of the gel.
However, the placebo used in the study also demonstrated statistically significant and clinically meaningful top line results, meaning that the study did not meet primary endpoints versus placebo.
The placebo did not contain glyceryl trinitrate (GTN), MED2005’s key ingredient, but did contain key ingredients that constitute DermaSys’ proven transdermal technology and was shown to be as effective in the treatment of ED as the active doses.
These results provide the company with a new, potentially simpler regulatory pathway for DermaSys as a medical device compared with MED2005 as a drug.
Futura Medical CEO 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.
“We will provide shareholders with an update on what we believe will be a new simpler and expected lower-cost regulatory pathway as soon as possible.”