Daewoong Pharmaceutical: "Fexuclue Safe to Use with Aspirin"

by Lee Myeonghwan

Published 27 Feb.2023 14:04(KST)

Research on Combined Administration of Aspirin Published in International Academic Journal

Daewoong Pharmaceutical announced on the 27th that the clinical results of the new drug for gastroesophageal reflux disease, Pexuclu (active ingredient: Pexuprazan Hydrochloride), in combination therapy with aspirin have been published in the international academic journal "Pharmaceutics."

Daewoong Pharmaceutical Researcher. [Photo by Daewoong Pharmaceutical]

The title of the paper is "A Clinical Study to Evaluate the Pharmacodynamic and Pharmacokinetic Drug Interactions Between the New Potassium-Competitive Acid Blocker (P-CAB) Pexuprazan and Aspirin in Healthy Subjects." The journal "Pharmaceutics," where the study results were published, is a prestigious international academic journal.

Aspirin plays a central role not only in pain relief but also in the primary and secondary prevention of cardiovascular and cerebrovascular diseases. However, since taking aspirin can cause side effects such as gastric or duodenal ulcers, it is recommended to combine it with a proton pump inhibitor (PPI) to prevent these complications.

However, PPI formulations take time to exhibit their effects and have restrictions on dosing times, so alternative treatments in the P-CAB (potassium-competitive acid blocker) class for gastroesophageal reflux disease are being developed. Pexuclu, a P-CAB class treatment, acts on the proton pump without requiring drug activation, resulting in rapid onset of effect and achieving maximum drug efficacy from the first day of administration.

This study was conducted to confirm the possibility of combination therapy with aspirin based on the efficacy of Pexuclu by evaluating pharmacokinetic and pharmacodynamic interactions as well as safety and tolerability through a randomized, open-label Phase 1 clinical trial. The clinical trial was conducted over three months from March to June 2022 at the Clinical Trial Center of Seoul National University Hospital, involving healthy adults. Pexuclu (80 mg) and aspirin (500 mg) were administered to 22 subjects for 2 to 3 weeks, and blood samples were collected 48 hours after dosing to evaluate pharmacokinetic and pharmacodynamic parameters.

The study results confirmed that there were no significant pharmacokinetic or pharmacodynamic interactions when Pexuclu and aspirin were co-administered, and no issues with safety or tolerability were observed. The platelet aggregation rate in the combination therapy group was statistically similar to that in the monotherapy group, confirming that the efficacy of aspirin was not affected. Furthermore, comparison of drug and metabolite blood concentrations showed no clinically significant drug interactions. Safety and tolerability results also demonstrated no statistically significant differences between groups in the incidence of adverse events or drug-related adverse reactions, confirming safety.

Lee Chang-jae, CEO of Daewoong Pharmaceutical, stated, "This clinical trial confirmed that there are no issues with the combined administration of Pexuclu and aspirin," adding, "We expect it to firmly establish itself as a new option for patients taking aspirin."