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news.Korea's leading pharmaceutical company Dong-A Pharmaceutical has received marketing approval from the Korean drug regulator for its erectile dysfunction drug Zydena.
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The drug will compete with Pfizer’s Viagra, Lilly’s Cialis, and Bayer/GSK’s Levitra for a share of the estimated $100 million erectile dysfuntion market in Korea.
Various phase II and III clinical studies have shown that Zydena produced highly significant improvement in erectile function after 12 weeks of drug therapy, with up to 76% intercourse completion rate compared to 15% for the placebo group.
Additionally, 48% of the patients in phase III clinical studies at the high dose level returned to normal function after 12 weeks on the drug compared to only 4% on placebo. The overall patient satisfaction as measured by the standard global assessment question was up to 89% in the high dose treatment group compared to 26% in the placebo group.
The most frequently noted side effects were mild to moderate facial flushing and headache which are expected for this class of drug.
“We are extremely pleased to see the marketing approval of Zydena in Korea. This is an important milestone in our plan to develop udenafil globally, not only for erectile dysfunction but also for numerous other indications,” stated Dr Shin-Ho Kang, chairman of Dong-A Pharmaceutical.