Medytox said Wednesday that it would begin Korea’s first phase 3 clinical trial for using Medytoxin, its botulinum toxin (BTX) product that treats overactive bladder.
|Medytox headquarters in Samsung-dong, Seoul|
The company announced the launch of its phase 3 research after the Ministry of Food and Drug Safety gave the go-ahead for the trial on April 17.
Overactive bladder is a disorder, in which the contraction of the bladder muscle occurs abnormally frequently or causes abnormalities in urination due to neurological disorders. According to the company, the disease affects one out of every five adults, while more common in the elderly and women.
Medytox plans to conduct the phase 3 clinical trial in 216 patients with overactive bladder symptoms at more than eight hospitals, including Asan Medical Center and Samsung Medical Center, to confirm the safety and efficacy of the treatment. The trial will be a multi-center, randomized, double-blind, and placebo-controlled study.
The BTX formulation inhibits the secretion of acetylcholine, a neurotransmitter needed for muscle contraction in a body. The company plans to inject the treatment into the bladder by using endoscopy and suppressing excessive bladder muscle contraction caused by abnormal nerve stimulation.
“Botulinum toxin is commonly known to be used for cosmetic purposes, such as wrinkles, but it is used more actively in advanced countries, such as the U.S. and Europe, as a treatment,” a company official said. “As a leading company in the industry, we will continue to develop indications for our BTX to meet the unmet needs of medical staff and patients.”
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