Fast-acting erectile dysfunction drug udenafil is coming: Dong-A PharmTech

Udenafil  has a  faster  onset of action  and  can be effective for up to 24 hours

Udenafil, a fast acting efectile dysfunction pill from the family of Viagra, is currently completing final phase clinical studies in US.

Udenafil, which is currently sold under the brand name Zydena in South Korea, will be studied in erectile dysfunction patients in 80 cities in US.

Udenafil’s randomized, double-blind, placebo-controlled trials will enroll approximately 1,120 subjects who have erectile dysfunction. Dong-A PharmTech hopes to complete these Phase III trials as well as other trials in the European Union and other major markets within two years.

Udenafil (Zydena) is originaly developed by the Korean firm Dong-A PharmTech Co. Ltd.

Udenafil (Zydena) is a phosphodiesterase type 5 (PDE5) inhibitor.

Udenafil produced highly significant improvement in erectile function after 12 weeks of drug therapy with up to a 92% vaginal penetration success rate compared to 53% for the placebo group and up to 76% intercourse completion rate compared to 15% for the placebo group, in various Phase 2 and 3 clinical studies.

The overall patient satisfaction as measured by the standard global assessment question (GAQ) was up to 89% in the high dose udenafil treatment group compared to 26% in the placebo group.

Udenafil also has a unique pharmacokinetic profile (Tmax of 1.0-1.5 hours and a half-life of 11-13 hours) suggesting that the drug could have a relatively rapid onset and sufficiently long duration to make it effective for up to 24 hours.

In a separate study involving more than 100 subjects to confirm udenafil’s long duration, the drug was shown to be efficacious in 55% of the ED patients after 8 to 12 hours.

Prior studies have also demonstrated a selectivity profile for udenafil that is similar to sildenafil but unlike tadalafil, it does not significantly inhibit the PDE11 isozyme and thus is not expected to produce significant myalgia.

No myalgia, back pain, or leg pain was observed in the Phase 3 studies for udenafil.

The most frequently noted side effects with udenafil were mild to moderate facial flushing and headache which are expected for this class of drug.

Dong-A PharmTech Co. Ltd said its US partner, Warner Chilcott plc, has started two Phase III trials for the new PDE-5 drug.

Dong-A PharmTech hopes to complete these Phase III trials as well as other trials using Udenafil in the European Union and other major markets within two years.

Dong-A PharmTech also plans to initiate Phase 2b clinical trials that will evaluate the safety and efficacy of udenafil for treatment of benign prostatic hyperplasia and pulmonary arterial hypertension.

Udenafil got approval to treat erectile dysfunction in Korea in November 2005.

Udenafil (Zydena) was also approved for marketing in Russia in July 2008.

If approved in US, udenafil will compete with Cialis (tadalafil), Levitra (vardenafil), and Viagra (sildenafil) for treatment of erectile dysfunction.

According to an analysis by the American College of Physicians of 130 studies that evaluated PDE-5 inhibitors alone or in combination, treatment with the currently available drugs resulted in statistically significant and clinically relevant improvements in sexual and erectile function in men with ED, regardless of the cause (e.g., depression, diabetes, prostate cancer).

Erectile dysfunction is an inability to achieve or sustain an erection suitable for sexual intercourse. It affects approximately 18 million men in the United States.

Dong-A Pharmaceutical, one of the Korea’s leading research-based pharmaceutical and healthcare companies. Dong-A Pharmaceutical has kept its No. 1 position in the Korean pharmaceutical market since 1967 with its Zydena(erectile dysfunction treatment), Stillen(gastritis treatment), Bacchus(refreshing tonic) and other 120 products.