Futura Medical PLC (LON:FUM) said it has fulfilled one of two requirements needed to attain EU regulatory sign-off for its erectile dysfunction (ED) gel.
It has done so by securing a positive audit opinion for the quality management systems (QMS) around its sexual health product MED3000.
The next stage official requires sign-off of the technical documentation providing efficacy, safety and quality data, which was submitted to the authorities in July.
Futura said it is still expecting to receive European approval next year.
“In parallel with the regulatory processes and executing upon our strategic plans, Futura has now appointed specialised corporate advisers with international experience to facilitate commercial discussions with potential licensing and marketing partners," the company’s chief executive, James Barder said in a statement.
Futura expects to develop MED3000 as both an over the counter product and prescription treatment for erectile dysfunction.
“If successful, EU approval will allow MED3000 to be marketed throughout the EU including the UK without the need of a doctor's prescription subject to any national marketing restrictions,” explained Barder.
The gel stands out because of its quick speed of onset and tolerability. The latter is a key point as many men struggle with the side effects of the blue pills used to treat ED.
As CEO Barder pointed out, these attributes “combined with efficacy will provide a new, highly accessible option for many patients suffering from the debilitating effects of the condition".