The Ministry of Food and Drug Administration said it has approved Dong-A ST to conduct a phase-2b trial on DA-8010, an investigational drug for overactive bladder.
The study will be a therapeutic and exploratory trial on local 300 patients with an overactive bladder to confirm the treatment’s efficacy and safety.
The trial will take place at Samsung Medical Center, Asan Medical Center, Severance Hospital, Ewha Womans University Medical Center, Konkuk University Medical Center, Hallym University Sacred Heart Hospital, and Boramae Hospital.
Overactive bladder causes a sudden urge to urinate. Patients with overactive bladder find it difficult to stop the call.
One of the typical treatments for overactive bladder is antimuscarinic agents, which inhibit muscarinic receptors of acetylcholine, a neurotransmitter, to alleviate symptoms by reducing bladder sensation and detrusor muscle’s activity.
According to Dong-A ST, DA-8010 has better efficacy in suppressing the bladder’s spontaneous contraction than conventional antimuscarinic agents.
The experimental drug is expected to improve conventional antimuscarinic agents’ major disadvantages such as thirst and constipation, often shown in the use of Astellas’ Vesicare (ingredient: solifenacin succinate), Dong-A ST said.