ZYDENA Poised to Enter Global Market with Phase III Clinical Trial Starting for US FDA Approval

Phase III clinical trial has started for Zydena to obtain approval of the US FDA. Zydena is an erectile dysfunction treatment developed by Dong-A Pharmaceutical of South Korea. The trial studies will be carried out by Warner-Chilcott, a US partner of Dong-A, with about 1,120 erectile dysfunction patients at 80 institutions in the US in order to evaluate the safety and efficacy of udenafil, the active ingredient of Zydena. The US market for erectile dysfunction treatments is estimated at 3.3 billion USD or about 4.5 trillion KRW. The competing treatments in the huge market are Viagra by Pfizer, Cialis by Eli Lilly, and Levitra by Bayer Healthcare. “Zydena’s outstanding record of efficacy and safety and minimal side effects such as headaches for the past three years in Korea shows that it is safe and powerful. The drug also demonstrated superb efficacy in addressing erectile dysfunction in Phase II trial in the US,” says the spokesperson for Dong-A. He also adds, “The Phase III studies in the US are meaningful in Zydena’s moving beyond the Korean market to reach global consumers as a new global drug. We are planning to complete the Phase III trial within the next two years, and once it is launched in the US market, we expect it to emerge as a strong competitor thanks to its long-lasting effectiveness and remarkable safety.” The drug’s active ingredient, udenafil, was given the green light for marketing by the Korea Food and Drug Administration in December 2005, and was introduced in the Korean market under the brand name Zydena. Zydena had since been prescribed over one million times for about 6 million tablets until the first half of 2009 thanks to its strong efficacy and safety. As of the end of last year, the drug was ranked second in sales volume in the Korean market. It has also fared notably well in foreign markets among the drugs developed by Korean drug firms. To date, it has entered 32 countries around the world, boasting exports agreements totaling 300 million USD, thereby opening a new chapter in the history of Korean-developed drugs in global markets. For instance, it acquired marketing permission in Russia in July last year and started selling under the same brand name, “Zydena” (written as “Зидена” and pronounced as /zidena/), in March this year.

The release as fetched from its publisher. donga-st.com ↗