leadf
logo-loader
viewFutura Medical PLC

Futura Medical moves nearer EU sign-off for erectile dysfunction gel

Ther group has done so by securing a positive audit opinion for the quality management systems (QMS) around its sexual health product MED3000

Futura Medical PLC -

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".

Quick facts: Futura Medical PLC

Price: 14.25 GBX

AIM:FUM
Market: AIM
Market Cap: £35 m
Follow

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

In exchange for publishing services rendered by the Company on behalf of Futura Medical PLC named herein, including the promotion by the Company of Futura Medical PLC in any Content on the Site, the Company receives...

FOR OUR FULL DISCLAIMER CLICK HERE

Futura Medical kicks off work on Phase III trial for erectile dysfunction gel

James Barder, chief executive of Futura Medical PLC (LON:FUM), tells Proactive they've begun preparatory work on the first Phase III efficacy trial for MED2002 - their topical gel for erectile dysfunction (ED). The study will recruit approximately 1,000 patients with mild, moderate and...

on 27/4/18

2 min read