Futura Medical PLC (LON:FUM) said a pivotal clinical trial of its gel for erectile dysfunction (ED) had been a resounding success.
It means the company now has a differentiated product in a market worth US$5bn that is currently dominated by top-selling drugs such as Viagra and Cialis that have limitations.
The study of 232 men successfully demonstrated MED2002’s efficacy, safety and speed of onset.
The drug scored success across all groups tested – mild, moderate and severe cases – but did particularly well in men with mild ED.
A total of 82% of the patients with the mild form of the condition said MED2002 began working within 10 minutes, with 54% reporting onset within five minutes.
No safety concerns were registered, which means the gel could be positioned as a consumer health product at the right dosage as well as being a prescription-based medicine.
Futura said the results will form the basis of “commercialisation strategy” for MED2002.
“The headline data from the study indicate that we have a breakthrough ED product that is not only effective but may also combine potentially the world's fastest speed of onset for an ED treatment with a very favourable safety profile,” said chief executive James Barder.
“We will carry out further analysis of the results in the next few days and are very excited by the commercial potential of this product."
Research commissioned by Futura found a widespread dissatisfaction with the current crop of ED pills, with the speed of onset being the most common complaint.
MED2002 provides a far more rapid solution to what's out there currently. It takes five to ten minutes before the effect is felt versus 20 for the likes of Viagra.
All of this provides an opportunity: a ready-made market of men who either can’t or don’t like taking the current help available.
It is probably more appropriate to classify Futura as a med-tech rather than a traditional pharma or biotech firm. And this is a crucial distinction.
For what it has created is a mode of action that gets drugs through the skin more quickly and effectively than other gels of this type.
It is a patented delivery method. For erectile dysfunction, it is incorporated with glyceryl trinitrate, which has been used to treat angina for decades.
You won’t be surprised to learn, then, the technology is being developed to carry traditional and well tolerated painkillers quickly and effectively to the point they are most needed.
It means the company is not a one trick pony – it has a pipeline quick-to-market products that have consumer and medical indications.