04 January 2018

Futura Medical's fast-acting topical erectile dysfunction drug MED2005 shows potential as a first-line treatment, following publication of Phase II trial data in the Journal of Sexual Medicine

Futura Medical today announced the publication of its Phase II trial of MED2005 in erectile dysfunction (ED) in the Journal of Sexual Medicine.1 The study showed that MED2005 delivers a rapid onset of action and significant improvements in Erectile Function, with a favourable safety profile.

The randomised, double-blind, placebo-controlled, crossover study evaluated the efficacy and tolerability of MED2005 in treating ED. MED2005 is a topical gel applied directly to the glans of the penis that contains 0.2% w/w glyceryl trinitrate and DermaSys® technology, an enhanced topical absorption system that facilitates rapid drug delivery across the skin barrier.

The study of 230 men with confirmed mild, moderate or severe ED, aged 18-70 years, was carried out at one site in the UK and three in Poland. Participants received MED2005-placebo or placebo-MED2005 for 4 weeks per treatment sequence separated by a 1-week treatment-free period. The primary outcome measure of the International Index of Erectile Function-Erectile Function (IIEF-EF) score which is the gold standard measure of efficacy for ED,2 and was significantly improved with MED2005 compared to placebo. For the overall study population IIEF-EF scores increased from 18.5 with placebo to 19.6 with MED2005 (p=0.0132), with a larger increase of 1.81 observed in men with mild ED (p<0.0001).

Treatment with MED2005 was also associated with significant improvements in secondary outcome measures from the IIEF of orgasmic function (p=0.012), sexual desire (p<0.0001), intercourse satisfaction (p=0.0055) and overall satisfaction (p=0.001) compared to placebo. Onset of erection occurred within 10 minutes for 70% of participants on average.

MED2005 was very well tolerated during the trial with no reported serious adverse events related to the treatment and no withdrawals from the study due to adverse events. The incidence of adverse events in female partners was extremely low, with only 4 treatment-related mild adverse events in 1,003 intercourse attempts. This included 2 mild headaches, and indicates little or no transference of the active ingredient to the partner during intercourse or application of the gel.

During 2018 Futura Medical will commence two Phase III trials to evaluate the safety and efficacy profile of the product at varying dose levels in a larger patient population. Higher doses will be trialled to improve the clinical significance in cases of moderate and severe ED.

James Barder, CEO of Futura Medical, said: "We are extremely encouraged by this Phase II data and in particular the rapid onset which can help restore spontaneity and greater intimacy for men with ED. We are also excited by the interest our asset is generating, and continue in our out-licensing discussion to find a commercial partner who can help bring MED2005 to men who suffer from ED."

Professor David Ralph Consultant Urologist at St Peter's Andrology Centre & Institute of Urology, UCLH, London, past President of the European Society of Sexual Medicine, and study author said: "The positive data from this study provides an exciting new innovation with the potential to be a first line therapy in ED. MED2005 has the required efficacy, speed of onset and safety profile consistent for an over-the-counter as well as prescription use product. MED2005, for the first time in the treatment of ED, has the potential to meet the needs of primary care providers and of patients".

The full paper may be accessed from http://www.jsm.jsexmed.org/article/S1743-6095(17)31852-0/fulltext

 

About erectile dysfunction

ED is the inability to get and/or sustain an erection for sexual intercourse. Prevalence and severity increases with age and overall is estimated to affect one in five men worldwide.3 The condition can be associated with chronic disorders such as diabetes and hypertension, and the frequency is likely to increase with an aging male population.4,5 ED can have a severe effect on quality of life for patients and their partners, with an impact on psychological wellbeing, self-esteem and relationships.6

The current first-line therapeutic class for ED is PDE5 inhibitors. The current dropout rate for ED patients taking PDE5 inhibitors is approximately half beyond the first year of use7 and PDE5 inhibitors are contra-indicated in individuals taking nitrates to treat conditions such as angina. They are also associated with adverse events including headache, back pain and visual disturbances.8 PDE5 inhibitors have a delayed speed of onset, and men are required to take their medication from half an hour to an hour before they expect to have sexual intercourse.9 This planned timing of medication can be a barrier to spontaneity and intimacy as sexual intercourse becomes a scheduled activity, and this can be a factor leading to long-term failure to continue treatment with a PDE5 inhibitor. There are substantial unmet needs in the treatment of ED.

 

About MED2005

MED2005, a refined formulation of MED2002, is a topical gel containing glyceryl trinitrate in combination with DermaSys® for the treatment of ED. Glyceryl trinitrate acts as a nitric oxide donor and promotes erection through relaxing the cavernosal smooth muscle and dilating penile arteries. The product is applied directly to the glans of the penis by the male or his partner, and works rapidly to help achieve and maintain an erection.

 

About Futura Medical

Futura Medical, based in Surrey UK, is a pharmaceutical company that develops products for both prescription and consumer healthcare markets. The company focuses on innovative transdermal drug delivery technology and has developed DermaSys®, an advanced proprietary transdermal delivery system, which can efficiently deliver drugs through the skin. Futura Medical is developing a portfolio of products for the sexual health and pain relief markets that utilise the DermaSys® technology with a view to licensing the sales and marketing of these products to major pharmaceutical and healthcare groups. The company is listed on the AIM market of the London Stock Exchange. More information about Futura Medical is available at http://www.futuramedical.com .

 

References

  1. Ralph DJ, Eardley I, Taubel J, et al. J Sex Med. doi:10.1016/j.jsxm.2017.12.003. [Epub ahead of print]
  2. Rosen RC, Fisher WA, Eardley I Niederberger C, Nadal A, Sand, M and MALES Study. Curr Med Res Opin. 2004;20(5):607-17.
  3. Shabsigh R, et al. J of Urol. 2005;174:662-667
  4. UN world population report. July 2015. Accessed from http://www.un.org/en/development/desa/news/population/2015-report.html
  5. Kubin M, Wagner G and Fugl-Meyer AR. Int J Impot Res. 2003;15(1):63-71.
  6. Tomlinson J and Wright D. BMJ. 2004;328(7447):1037. Epub 2004 Mar 29
  7. Smith WB 2nd, McCaslin IR, Gokce A, Mandava SH, Trost L and Hellstron WJ. Int J Clin Pract. 201;67(8):768-80
  8. Hatzimouratidis K, et al. European Association of Urology - Guidelines on Male Sexual Dysfunction 2014. Accessed from https://uroweb.org/wp-content/uploads/14-Male-Sexual-Dysfunction_LR.pdf
  9. Huang SA and Lie JD. P T. 2013;38(7):407-19

 

Forward-looking statements:

This press release contains forward-looking statements. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the development and testing of our drug candidates, the regulatory approval process, our ability to secure additional financing, the protection of our patent and intellectual property, the success of strategic agreements and relationships, and the potential commercialization of any product we may successfully develop. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the dates on which they are made.

 

For further information please contact:

Futura Medical plc
James Barder, Chief Executive
+44 (0) 1483 685 670
james.barder@futuramedical.com
www.futuramedical.com

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