Vardenafil HCI (Staxyn, GlaxoSmithKline, Merck, and Bayer), an orally disintegrating tablet indicated for the treatment of erectile dysfunction (ED) in men, is now available in U.S. pharmacies. It is the first and only orally disintegrating tablet to treat ED.

Staxyn was FDA approved in June 2010.

According to Bernadette King, director, product communications, GlaxoSmithKline, FDA approval of Staxyn was based on results from 2 pivotal clinical studies designed to evaluate the efficacy and safety of Staxyn for the treatment of ED.

“In these studies, Staxyn treatment significantly improved erectile function compared to placebo in a population of men with ED,” King told Drug Topics.

Staxyn is sold in a unique sliding pack, about the size of a credit card. Each pack contains four 10 mg orally disintegrating tablets, protected by a childproof blister pack that also protects the tablet.

It is estimated that up to 30 million men in the United States have experienced at least some degree of ED. The greatest number of men who use prescription medication for ED are aged 45 to 65 years.

Common risk factors for ED are diabetes, high blood pressure, high blood cholesterol, smoking, and cardiovascular disease.