The FDA recently approved Aralez Pharmaceuticals’ Yosprala, a once-daily, fixed-dose combination of the antiplatelet agent aspirin and the proton pump inhibitor omeprazole.
is indicated for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events, as well as those at risk of developing aspirin-associated gastric ulcers. It contains 40 mg of immediate-release omeprazole and either 81 mg or 325 mg of delayed-release, enteric-coated aspirin. It is not interchangeable with the individual components of aspirin and omeprazole.
The drug’s launch is planned for the first week of October 2016.
“The approval of Yosprala …helps address the current public health dilemma around patient discontinuation of daily aspirin therapy, which has potentially serious consequences,” stated Aralez Chief Executive Officer Adrian Adams in a press release. “Yosprala is designed to help at-risk patients, who need the cardioprotective benefits of daily aspirin, stay on their important treatment while reducing the risk of developing gastric ulcers. We believe Yosprala represents an important new therapeutic option for this group of patients and health care providers who strive to improve patient adherence to daily aspirin therapy.”
Yosprala’s approval was based on the results from 2 randomized, double-blind, controlled clinical trials that compared Yosprala 325 mg/40 mg with 325 mg of enteric-coated aspirin. Each study achieved its individual primary endpoint with patients in the Yosprala arm experiencing significantly fewer endoscopic gastric ulcers than those taking enteric-coated aspirin alone. In addition, significantly fewer patients treated with Yosprala discontinued therapy because of prespecified upper gastrointestinal adverse events compared with those in the enteric-coated aspirin arm.
The most common adverse effects associated with Yosprala are indigestion, heartburn, nausea, stomach-area pain, diarrhea, growths in the stomach, and chest pain. Patients and health care professionals should also watch for kidney and liver problems, low magnesium and vitamin B12 levels, bone fractures, and diarrhea caused by Clostridium difficile
during Yosprala use.