A Korean drugs company has begun stage III trials for its new erectile dysfunction medication, Zydena. The trials are taking place in the U.S, with the ultimate aim of receiving approval from the FDA.
Dong-A are working with U.S partners Warner Chilcott PLC to complete the trials into the drug, which will be randomized, double-blind and placebo controlled. 1,100 men are expected to take part in the trials,which will be taking place in 80 different locations across America. They are designed to look at safety as well as how effective the drug is.
In a statement, the company announced that they were hoping to complete clinical trials for the U.S and the European Union within two years.
In 2005 Udenalfil – the medical name for Zydena - was approved by the Korean Food and Drug Administration in 2005 and went on sale there in early 2006. It was also approved by the Russian drug regulators in 2008 and went on sale there in 2009. Since it went on sale in Korea, the drug has been a fairly big seller, with over 6 million tablets prescribed for men with erectile dysfunction.
The medication is part of the same category of medication that Viagra, Cialis and Levitra belong to, phosphodiesterase type 5 (PDE-5). If it does receive approval it will be in direct competition with the more established medications.