Vivozon Pharmaceutical Obtains MFDS Approval for Tablet-Type Bowel Cleanser 'Lalapang Tab'

Vivozon Pharmaceutical has received product approval from the Ministry of Food and Drug Safety for its new tablet-type bowel preparation, "Lalapang Tab," which offers improved dosing convenience and enhanced bowel cleansing effects compared to existing products.

원본보기 아이콘

According to Vivozon Pharmaceutical on May 6, Lalapang Tab has been approved for use as a "bowel cleanser for pre-colonoscopy preparation." The efficacy of this bowel preparation was previously demonstrated in a Phase 3 clinical trial. The trial was conducted with 240 participants who took Lalapang Tab for bowel cleansing prior to colonoscopy. In the primary evaluation variable, the Harefield Cleaning Scale, Lalapang Tab showed non-inferiority compared to the active comparator, "Orapang Tab" from Korea Pharma Bio, thereby confirming its bowel cleansing effectiveness.

Lalapang Tab enhances bowel cleansing effect by adding sodium picosulfate to the main ingredient of existing products. Vivozon Pharmaceutical is in the process of registering a composition patent for a formula combining four ingredients: sodium picosulfate, potassium sulfate, magnesium sulfate, and simethicone.

In addition to its bowel cleansing effect, Lalapang Tab also improves dosing convenience. The single dose has been reduced to 10 tablets, down from the previous 14 tablets. The size and weight of the tablets have also been decreased, improving patients' compliance with medication.

A representative from Vivozon Pharmaceutical stated, "Lalapang Tab is a next-generation bowel preparation developed with patient convenience in mind, and its efficacy, safety, and convenience have all been demonstrated in clinical studies," adding, "Our goal is to launch the product within July."

© The Asia Business Daily(www.asiae.co.kr). All rights reserved.