• >50% fewer endoscopic gastric ulcers with Yosprala vs EC aspirin in 2 identically designed studies in aspirin-tolerant patients2,3
• 82% fewer patients treated with Yosprala discontinued therapy due to pre-specified upper GI AEs vs EC aspirin3
AE, adverse event, CV, cardiovascular, EC, enteric-coated, GI, gastrointestinal.
Yosprala proprietary Intelli-COAT™ system is designed to sequentially deliver immediate-release omeprazole and delayed-release aspirin1,2
pH-sensitive coating dissolves at pH >5.51
For illustration purposes only. Not a visual representation of the tablet.
• Yosprala is not interchangeable with the individual components of aspirin and omeprazole1
Study design: Efficacy of the omeprazole component in Yosprala was evaluated in 2 randomized, multicenter, double-blind, 6 month, Phase 3 trials in patients who had a cerebrovascular or CV diagnosis and were taking 325 mg of aspirin for ≥3 months, expected to continue treatment for ≥6 months, and at risk for aspirin-associated gastric ulcers based on being ≥55 years-of-age or 18 to 54 years old with a documented history of gastric or duodenal ulcer within the 5 years before study enrollment. Patients received Yosprala 325-mg delayed-release aspirin/40-mg immediate-release omeprazole or 325-mg of enteric-coated aspirin. Gastric and duodenal ulcer formation was assessed by gastroduodenal endoscopy at screening and after 1, 3, and 6 months of treatment.2,3-5
|EC aspirin, 325 mg (n=524)||Yosprala, 325 mg/40 mg (n=521)|
|Noncardiac chest pain||1%||2%|
References: 1. Miner PB, Fort JG, Zhang Y. Intragastric acidity and omeprazole exposure during dosing with either PA32540 (enteric-coated aspirin 325 mg + immediate-release omeprazole 40 mg) or enteric-coated aspirin 325 mg + enteric-coated omeprazole 40 mg–a randomised, phase 1, crossover study. Aliment Pharmacol Ther. 2013;38(1):62-71. 2. Yosprala Prescribing Information. Charleston, WV: Innovida Pharmaceutique Corporation; 2018. 3. Whellan DJ, Goldstein JL, Cryer BL, et al. PA32540 (a coordinated-delivery tablet of enteric-coated aspirin 325 mg and immediate-release omeprazole 40 mg) versus enteric-coated aspirin 325 mg alone in subjects at risk for aspirin-associated gastric ulcers: results of two 6-month, phase 3 studies. Am Heart J. 2014;168(4):495-502. 4. Data on file. #0267. Innovida Pharmaceutique Corporation 5. Data on file. #0266. Innovida Pharmaceutique Corporation