GSK/Bayer's Levitra approved by FDA
Levitra (vardenafil HCl), co-developed and co-promoted by Bayer AG and GlaxoSmithKline has been approved by the Food and Drug Administration (FDA) for the treatment of erectile dysfunction (ED).
Levitra (vardenafil HCl), co-developed and co-promoted by Bayer AG and GlaxoSmithKline has been approved by the Food and Drug Administration (FDA) for the treatment of erectile dysfunction (ED).
It provides men with their first new ED treatment choice in five years, and is expected to be available in US pharmacies nationwide within the next few weeks.
'In clinical trials, Levitra was shown to work quickly and, more importantly, was shown to improve the sexual response for the majority of men the first time they took it, and it worked consistently over time,' said Dr Myron Murdock, Levitra investigator and nationally recognised expert in the field of male sexual dysfunction.
'Today's approval of Levitra means there is now an important alternative in the treatment of erectile dysfunction,' said Colin J Foster, president, Bayer Pharmaceuticals Corporation. 'We aim to reach out to the 30m men in the US with erectile dysfunction.'
'We're delighted with the approval of this promising new therapy,' said Chris Viehbacher, president, US Pharmaceuticals, GlaxoSmithKline. 'Together with Bayer, we are committed to educating men and their doctors about Levitra and the important role it can play in improving their sexual health.'
What is Levitra?
Levitra is a medicine that may be used up to once a day to treat erectile dysfunction (ED). It is for use by prescription only. Men taking nitrate drugs, often used to control chest pain (also known as angina), should not take Levitra. Men who use alpha blockers, sometimes prescribed for high blood pressure or prostate symptoms, also should not take Levitra. Such combinations could cause blood pressure to drop to an unsafe level. The most commonly reported side effects are headache, flushing, and stuffy or runny nose. Men who experience an erection for more than four hours should seek immediate medical attention.
Erectile dysfunction
Erectile dysfunction (ED) - the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance - is a common health condition among men that is largely untreated. It is estimated that some degree of ED affects more than one half of all men over the age of 40 - 152m men worldwide and 30m men in the United States alone. Despite the high prevalence of sexual problems, nine out of 10 men in the US have not yet sought treatment from a physician.