Styren evolves: Dong-A ST submits approval application for once-daily gastritis drug Styren Q

Dong-A ST has moved toward commercialization by submitting a Korean marketing approval application for Styren Q tablets, an improved version of its existing gastritis treatment Styren that reduces dosing from three times daily to once daily.

Dong-A ST disclosed on the 16th through its subsidiary Dong-A Socio Holdings that it had submitted a marketing approval application to the Ministry of Food and Drug Safety for Styren Q tablets, a treatment for acute and chronic gastritis. Styren Q tablets contain the same active ingredient as the existing Styren tablets but are an improved drug designed to substantially reduce dosing frequency.

The application was based on the results of a phase 3 trial involving 467 patients with acute or chronic gastritis. The trial was designed as a noninferiority study to demonstrate that 2 weeks of treatment with the investigational drug Styren Q tablets (development code, DA-5219) was not less effective than treatment with the existing Styren tablets.

The trial demonstrated noninferiority for the primary endpoint, the efficacy rate for gastric mucosal erosions on upper gastrointestinal endoscopy. The lower bound of the one-sided 97.5% confidence interval for the difference in efficacy rates between the two treatment groups was -13.87%, higher than the prespecified noninferiority margin of -14%, establishing statistical significance.

No meaningful differences were observed in safety. The incidence of adverse drug reactions was similar between the Styren Q tablets group, at 1.74% (4 patients), and the Styren tablets group, at 2.15% (5 patients). One serious adverse event occurred in each group, but both were reported as unrelated to the study drug.

Dong-A ST expects Styren Q tablets to substantially improve patient convenience and adherence if commercialized. The company plans to strengthen its gastritis treatment portfolio by adding a once-daily option to the existing once- or twice-daily dosing regimens.

Following approval by the Ministry of Food and Drug Safety, the company plans to complete the health insurance reimbursement listing process before fully launching the product in the Korean market.