Futura Medical has announced headline results from its pivotal efficacy study of MED2002, the company's novel gel for the treatment of erectile dysfunction.
The results of the study show that MED2002 has achieved its primary endpoint and successfully demonstrated efficacy, safety and speed of onset.
The study comprised a total of 232 randomised males and it measured, as its primary endpoint, improvement in the erectile function domain score of the International Index of Erectile Function, the scoring system used for the approval of PDE5 inhibitors such as Viagra. The study was of a placebo-controlled, double blind, home use, crossover design.
The study, which included mild, moderate and severe ED patients, achieved its primary endpoint in showing a statistically significant improvement in erectile function (p-value of 0.0132) in the EF domain score averaged across all groups of males when using MED2002 compared with placebo.
The results in the mild ED patient group were highly statistically significant with a p-value of 0.0001 on MED2002 compared with placebo, with nearly twice as many males reporting a clinically relevant improvement in the EF domain when using MED2002 compared with placebo.
The study used one dosage, 0.2% w/w glyceryl trinitrate gel, and Futura will consider whether the use of a higher dosage could provide further measurable benefit to the moderate and severe ED sufferers.
The speed of onset of action of MED2002 was rapid, partly reflecting the method of application with the gel being applied directly to the penis. 82% of patients with mild ED had an onset of action within 10 minutes and in 54% of mild ED patients onset was within 5 minutes.
This rapid onset of action means that MED2002 has the potential of being the world's fastest-acting treatment for ED.
No major safety concerns were identified. No serious adverse events or serious adverse reactions were recorded and there were no drop-outs from the study owing to side-effect issues.
This safety profile suggests that MED2002 could be positioned as a consumer healthcare product at an appropriate dosage in addition to being a prescription-based medicine.
The safety profile also supports MED2002's use in a significant area of unmet need in ED: the estimated 7.5% of ED sufferers who cannot be prescribed PDE5 inhibitors due to contraindications with other medicines taken by them.
The results from this study will form the basis of the commercialisation strategy for MED2002, which shares the same active ingredient as the Company's novel erectogenic condom, CSD500.
A more detailed analysis of the study results is being carried out over the next several days and further details are expected to be provided with the Company's half year financial results, to be issued on Tuesday 13 September 2016.
Futura chief executive James Barder said:: "I am delighted that our novel gel for the treatment of erectile dysfunction, MED2002, has met its primary endpoint by showing efficacy.
"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. 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." At 9:05am: (LON:FUM) Futura Medical PLC share price was +33p at 61.5p