First cream to treat men with erectile dysfunction available

The first topical cream approved for the treatment of erectile dysfunction (ED) in men over the age of 18 years, Vitaros^® (topical alprostadil cream), is now available for prescription in the UK.(1)
The new topical cream comes in a single use, disposable applicator that is easy to use and suitable for many of the 2.3 million men with ED in the UK.(1,2) Men in the UK will be the first in the world to have access to this new treatment for ED.

The first topical cream approved for the treatment of erectile dysfunction (ED) in men over the age of 18 years, Vitaros^® (topical alprostadil cream), is now available for prescription in the UK.(1)
The new topical cream comes in a single use, disposable applicator that is easy to use and suitable for many of the 2.3 million men with ED in the UK.(1,2) Men in the UK will be the first in the world to have access to this new treatment for ED.
It provides healthcare professionals with an alternative, non-invasive option for those men considering alprostadil treatment. After applying the pre-measured amount of cream (100μl) to the tip of the penis, the new skin permeation technology within the cream (NexACT®-DDAIP) results in the rapid absorption of alprostadil by loosening the epidermal tight junctions, producing an erection within five to 30 minutes.(1,3)

No catch-all treatment for men with erectile dysfunction
No one single treatment is suitable for all men with ED meaning many men miss out on the chance for treatment.(4–6) For example, some men cannot tolerate oral treatments due to systemic side effects, such as headache and dizziness, or cannot take them because they are contraindicated.(7–10)
As men with ED tend to be taking numerous medications for underlying medical conditions, some simply do not want to take another oral treatment. Many men are also put off by the existing administration methods for alprostadil, such as an injection into the penis or a pellet inserted into the urethra.(4–6,11,12)
Professor Raj Persad, Consultant Urologist and Andrologist, The Bristol Urological Institute, said, “Vitaros is an important step forward in the treatment of ED, particularly for those men where we struggle to find an appropriate treatment. It offers men an alternative option that acts locally and has non-invasive administration, meaning more men can potentially receive treatment for their ED.”
He added: “Current alprostadils are normally prescribed in secondary care because of the way they are administered. As Vitaros is easy to use and only needs verbal instruction around the application of the cream, it could potentially be prescribed in primary care, giving GPs and practice nurses the ability to treat more men with ED.”

Men with erectile dysfunction should seek medical advice

It is important that men suffering with erection problems go to see a healthcare professional as ED can be an early warning sign for serious conditions such as cardiovascular disease, indicating that a man could be at risk of angina or a heart attack within the next 3 to 5 years. This could occur even in men in their early forties.(2)
In the 12-week phase III placebo-controlled clinical trials (n=1,732), almost 40% of men using 300mcg of topical alprostadil experienced a clinically significant improvement in their erection function (IIEF-EF), compared to 21% of men using placebo (p<0.0001).(14) Over half of men were satisfied with their erection (measured by the Global Assessment Questionnaire [GAQ]) after using 300mcg of topical alprostadil compared with only 20% of men using placebo (p<0.0001).(13,14) In particular, more men with a variety of conditions such as diabetes, high blood pressure and cardiac disease (53% [n=42], 49% [n=91] and 50% [n=63], respectively), were satisfied with their erection after using 300mcg of topical alprostadil compared with those using placebo (20% [n=15], 20% [n=35] and 17% [n=19], respectively).(15)
In the long-term, open label study, the majority (90%) of men using 300mcg of topical alprostadil for 6 months considered their erection improved compared with their erection at the beginning of the trial (measured by GAQ).(16)
All common observed side effects of Vitaros treatment are localised to the application site and are generally mild and of short duration. Prolonged erections lasting more than 4 hours (priapism) were observed rarely. If priapism occurs, the man should seek immediate medical assistance.(1,16)
Vitaros is only available on prescription from a healthcare professional and is self-administered, after initial verbal instruction during the appointment.(1) The Health Service Circulars: HSC/115 [105], HSC/148 [106] and HSC/177 [107], published in 1999, outline restrictions for the prescription of ED treatments on the NHS. These restrictions mean that men can only receive an NHS prescription for their treatment if their ED is associated with the following medical conditions:(17)

•  diabetes;
• multiple sclerosis;
• Parkinson’s disease;
• poliomyelitis;
• prostate cancer;
• prostatectomy (including transurethral resection of the prostate [TURP]); and
• radical pelvic surgery

Renal failure treated by dialysis or transplant:

• severe pelvic injury;
• single gene neurological disease;
• spinal cord injury; and
• spina bifida

The prescription of Vitaros will also come under these restrictions. However, those men that require treatment for ED, but do not qualify for an NHS prescription, may still receive private prescriptions from their GP within an NHS consultation.(1)

References

1. Vitaros (alprostadil) summary of product characteristics.
2. Sexual Advice Association. Impotence or erectile dysfunction. Available at: http://www.sda.uk.net/ed [last accessed: June 2014].
3. Becher E, et al. Topical alprostadil cream for the treatment of erectile dysfunction. Expert Opin. Pharmacother 2004;5(3): 623–32.
4. Vardi Y. Logistic regression and survival analysis of 450 impotent patients treated with injection therapy: long-term dropout parameters. J Urol 2000;163(2):467–70
5. Yeager J, Beihn RM. Retention and migration of alprostadil cream applied topically to the glans meatus for erectile dysfunction. Int J Impot Res 2005;17:91–5.
6. Steidle C, et al. Topical Alprostadil cream for the treatment of erectile dysfunction: a combined analysis of the phase II program. Urology 2002;60:1077–82.
7. Viagra summary of product characteristics. Available at: http://www.medicines.org.uk/emc/medicine/1474/SPC/Viagra+25mg%2c+50mg%2c+100mg/ [last accessed: June 2014].
8. Cialis summary of product characteristics. Available at: http://www.medicines.org.uk/emc/medicine/11363/SPC/Cialis+2.5mg%2c+5mg%2c+10mg+%26+20mg+film-coated+tablets/ [last accessed: June 2014].
9. Levitra summary of product characteristics. Available at: http://www.medicines.org.uk/emc/medicine/11775/SPC/Levitra+5mg%2c+10mg%2c+20mg+film-coated+tablets/ [last accessed: June 2014].
10. Avanafil summary of product characteristics. Available at: http://www.medicines.org.uk/emc/medicine/28729/SPC/Spedra+50+mg,+100+mg+and+200+mg+tablets/ [last access: June 2014].
11. Caverject Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/1480/SPC/Caverject+Powder+for+Injection+5+Micrograms/ [last accessed: June 2014]l
12. MUSE Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/22220/SPC/MUSE+250+microgram+urethral+stick./ [last accessed: June 2014].
13. Padma-Nathan H, Yeager J. An integrated analysis of Topical alprostadil cream for the treatment of erectile dysfunction in 1732 patients. Urology 2006;68:386–91
14. Midas Pharma. RMS Day 120 Draft Assessment Report. 2012
15. Takeda Data on File. UK/DF/1312/0039
16. Rooney M et al. Long-term, multicenter study of the safety and efficacy of topical alprostadil cream in male patients with erectile dysfunction. J Sex Med 2009;6:520–34.
17. Hackett G, et al. British Society for Sexual Medicine Guidelines on the Management of Erectile Dysfunction. Available at: http://www.bssm.org.uk/downloads/BSSM_ED_Management_Guidelines_2007.pdf [last accessed: June 2014].