inno. N said that the Ministry of Food and Drug Safety has approved K-CAB orally disintegrating tablet (ODT) 50mg, a gastroesophageal reflux therapy.
The company plans to launch the new K-CAB formulation in the first half of this year, further spurring its share in the Korean peptic ulcer solvent market.
K-CAB ODT is a dosage form that patients can take without the need to drink water and has the advantage of greatly increasing the convenience of taking the tablet for patients who have difficulty swallowing or drinking water.
Based on such advantages, the company expects medical professionals to expand the prescription range for patients, increasing K-CAB's prescriptions this year.
The company also said that it is adding K-CAB Tablet 50mg’s indications and would apply for the approval of K-CAB ODT 25 mg based on the results of phase 3 clinical trial that ended last year.
"If we release the K-CAB ODT tablet in the first half of this year, we will provide more options to both medical workers and patients, having a positive effect on the increase in prescription performance," a company official said. "We plan to solidify K-CAB's market position by continuously researching indications, differentiated clinical trials, and development of various formulations."
K-Cab became Korea's 30th novel drug in 2018. It is the first potassium-competitive acid blocker (P-CAB) to obtain the indication for EE(Erosive esophagitis) and NERD(Non-erosive reflux disease) GERD in Korea.
According to the company, while conventional treatments, such as proton pump inhibitors (PPI), need three to five days to show efficacy, K-CAB drugs suppress gastric acid secretion in just one hour. In addition, K-CAB treatments also inhibit excessive secretion of gastric acid during nighttime, reducing chest pain and sleep disorder, it said.
The company has also introduced K-CAB to 27 countries, with its export amount surpassing 1 trillion won ($829.2 million). In addition, the drug is in the final stage of getting approval as a Class 1 new drug in China for release in the first half-year.