SHARE

AsianScientist (Apr. 15, 2013) – Barcelona, Spain-based biotech, Laboratorios SALVAT S.A., and South Korean pharma, Kwang Dong Pharmaceutical Co. Ltd., have successfully completed a Phase IIb clinical trial for Tarafenacin, a new drug under development for the treatment of Overactive Bladder syndrome (OAB).

Tarafenacin is a potent and selective M3 muscarinic antagonist for the treatment of OAB. According to study results by SALVAT, Tarafenacin in Phase I trials proved to be safe both in healthy young and elderly volunteers, while Phase II trials showed its excellent efficacy and tolerability profile.

Overactive Bladder syndrome is characterized by urinary urgency, with or without urgency-associated urinary incontinence. The prevalence of OAB ranges from 10 to 17 percent in the adult population, depending on sex and age.

This Phase IIb trial included 234 patients with OAB and was conducted in eight sites in South Korea: Asan Medical Center, Samsung Medical Center, Seoul National University Hospital, Severance Hospital, Seoul St. Mary’s Hospital, Cheil Medical Center, Ajou Medical Center, and Pusan National University Hospital.

According to SALVAT, Tarafenacin at doses of 0.2 mg and 0.4 mg proved superior to placebo after four weeks in reducing the number of micturitions per day, the main endpoint of the study. Promising results were obtained in secondary endpoints (volume voided per micturition, urinary urgency episodes, and quality of life related endpoints), it said. The drug also gave a low incidence of constipation.

Based on these encouraging results, SALVAT and Kwang Dong say they will move forward into Phase III clinical trials.

——

Source: SALVAT.
Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.