Positive Ph IIb results for SALVAT's tarafenacin in overactive bladder

Spanish drugmaker Laboratorios SALVAT and its South Koran partner Kwang Dong Pharmaceutical have released positive results of the Phase IIb clinical trial for tarafenacin (SVT-40776), a new drug under development for the treatment of overactive bladder syndrome (OAB).

In this Phase IIb trial, tarafenacin, at doses of 0.2mg and 0.4mg, 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). Tarafenacin showed the expected dose-efficacy response and confirmed the excellent safety profile described in previous trials due to its selectivity. Remarkable data on the low incidence of constipation was also obtained.

The clinical 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. These encouraging results allow SALVAT, which originated the drug, and Kwang Dong to move forward to Phase III in patients suffering with OAB.