Recruitment Closes in MED2002 Pivotal Study
04 May 2016
Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to announce that it has closed recruitment of patients into its pivotal clinical study of MED2002, the Company's novel, topical gel for the treatment of erectile dysfunction (ED).
Patient recruitment has taken place at four sites in the UK and Poland. Remaining appointments are being completed this week to give a total of around 360 patients consented into the study. This number is considered sufficient for the completion of the study, which requires the treatment of 192 eligible patients.
110 patients have already completed the study and the remaining 82 are expected to complete during the summer. Each eligible patient typically takes four months from the point of consent to completing the study, meaning that headline results are now expected in Q3 2016.
No serious adverse events have been recorded to date among the patients who have participated in the study, which is of a randomised, placebo-controlled, double blind, home use, crossover design.
This pivotal study began in June 2015 and its primary endpoint is the MED2002's efficacy in male subjects self-diagnosed with ED using the erectile function domain of the International Index of Erectile Function (IIEF). The IIEF is a well validated measure of erectile function and was used for the approval of PDE5 inhibitors, such as Viagra®. Secondary endpoints in the trial include the speed of onset, which the Company believes is an important claim for the product.
MED2002 is expected to be a prescription-only product. It has patent protection until 2025 in Europe and until 2028 in the USA.
James Barder, Futura's Chief Executive, commented: "We are very pleased to have closed recruitment into this pivotal study of MED2002 in erectile dysfunction, a condition with significant unmet medical need. We look forward to receiving the headline results of the study in Q3 2016. Commercialisation plans are already being prepared in anticipation of a successful study outcome."
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Notes to editors:
About Futura Medical plc
Futura Medical is a pharmaceutical group that develops innovative products for consumer healthcare. The Company is developing a portfolio of products and its strategy is to license their manufacture and distribution to major pharmaceutical and healthcare groups.
Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange.