Once-A-Day Pill For Impotence, UK

Main Category: Sexual Health / STDs
Article Date: 06 Feb 2009 - 4:00 PST

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UK men with impotence now have access to a daily tablet to treat their condition all day, every day. The new pill, Cialis® (tadalafil), Once-A-Day, is the first oral impotence treatment which is designed to enable couples to initiate sex whenever they wish.

This prescription-only medicine is likely to be suitable only for men with impotence who anticipate having sex more than once a week and who have responded to other oral impotence treatments taken on demand such as Viagra (sildenafil)1, Levitra (vardenafil)2 or tadalafil.3

Suitable men can take the pill as part of their daily routine3, making it similar to the management of many other chronic medical conditions.

Mr Suks Minhas, Consultant Urologist and Andrologist, says: "Existing oral treatments for impotence require an element of forward planning. This new daily treatment may allow some men suffering from impotence to respond freely to their partner any time, which could eliminate the pressure of limiting sexual relations to a timetable set around taking a tablet."

Research shows that 75% of men with erection problems dislike having "to plan or schedule sex"4 and 79% of men who use current oral impotence treatments do not find planned sex exciting.5

Impotence is the persistent or recurrent inability to get or maintain an erection sufficient to have sex.6 An estimated 2.3 million UK men have the condition which can be devastating and for many men underlying medical conditions such as diabetes or heart disease may be a contributory factor.6

Tadalafil, once-a-day, will be available on 3 February 2009, on prescription only. Side effects of tadalafil are generally mild to moderate, the most frequently occurring being headache or an upset stomach.3 The treatment only works with sexual stimulation.3

A copy of the tadalafil Summary of Product Characteristics (SPC) can be viewed here.

About Cialis

Tadalafil is available on demand and now once a day and is approved for the treatment of impotence, also known as Erectile Dysfunction (ED)3. Tadalafil on demand is currently available in more than 100 countries, including Australia, Brazil, Mexico, Canada, the United States and countries throughout Europe. More than 10 million patients worldwide have been treated with tadalafil on demand since its first introduction in February 2003. In Europe, tadalafil is available by prescription only and is taken as needed prior to sexual activity or in a daily regimen.3

The adverse events reported with tadalafil on demand and 5mg (once a day usage) were transient and generally mild or moderate. Very common (> 10%) side effects include headache and dyspepsia, common (> 1- <10%) side effects include dizziness, palpitations, flushing, nasal congestion, abdominal pain, gastro oesophageal reflux, back pain and myalgia. As with all other PDE5 inhibitors, the use of tadalafil is contraindicated in patients who are taking nitrates, for those who have cardiac disease in whom sexual activity is not advisable, and for those patients with non-arteritic anterior ischemic optic neuropathy (NAION).3

Cialis® (tadalafil) is a prescription only medicine licensed for the treatment of impotence.3 Cialis® Once-A-Day is a daily regimen of this therapy for patients who have responded to an on demand oral impotence treatment and who anticipate sexual activity at least once a week.3

About Impotence

Impotence is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse.6 There are an estimated 2.3 million men with impotence in the UK.6 Experts believe that impotence can be an early marker for silent coronary heart disease or diabetes.7 75% of impotence cases are related to a physical or medical condition, such as diabetes, cardiovascular diseases, and prostate cancer treatment; however, most men with impotence inevitably have a combination of psychological and physical causes to the condition.7

References

1. Viagra® SPC Electronic medicines compendium. Accessed on line November 2008 at http://emc.medicins.org.uk/. VI 16_0 First authorization: 14 September 1998 Last renewal: 14 September 2003.

2. Levitra® SPC Electronic medicines compendium. Accessed on line November 2008 at http://emc.medicins.org.uk/. First authorization: 6 March 2003 Last renewal: 6 March 2008.

3. Cialis® SPC Electronic medicines compendium Accessed on line November 2008 at http://emc.medicins.org.uk/. CI11M First authorization: 12 November 2002 Last renewal: 12 September 2007.

4. Men, Sex and Erectile Dysfunction: Through the Looking Glass, Survey 2002, Wirthlin, Europe 2002.

5. "Living with ED" Harris Interactive, The American Foundation for Urological Disease and Eli Lilly and Company Limited. 2003

6. Sexual Dysfunction Association impotence fact sheet June 2008 http://www.sda.uk.net/downloads/Impotence_or_erectile_dysfunction.pdf (last accessed 20 November 2008).

7. Hackett G, Dean J, Kell P, et al. (2007), British Society for Sexual Medicine Guidelines for the Management of Erectile Dysfunction, accessed from http://www.bssm.org.uk/download/default.asp in November 2008.

http://emc.medicins.org.uk/