OFFER YOUR PATIENTS MUTUAL
PROTECTION WITH YOSPRALA

Yosprala provides CV and GI protection with the coordinated delivery of aspirin and omeprazole.

Yosprala is designed to sequentially deliver immediate-release omeprazole and delayed-release aspirin for gastro- and cardioprotection1,2

• >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.

MECHANISM
OF ACTION

Coordinated omeprazole and
aspirin delivery with Yosprala

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

EFFICACY

Help protect patients from aspirin-associated gastric ulcers with Yosprala

>50% fewer endoscopic gastric ulcers with Yosprala vs EC aspirin
in 2 identically designed studies in aspirin-tolerant patients2,3


Primary endpoint: reduction in endoscopic gastric ulcers at 6 months2

50percent
82percent

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

• After 1 month of treatment and at all study time points, patients had fewer gastric ulcers with Yosprala vs EC aspirin2,3-5

71% fewer gastric and/or duodenal ulcers with Yosprala vs EC aspirin (3.4% vs 11.6% [P<0.001])2,3

Help reduce aspirin discontinuations due to upper GI AEs

82% fewer patients treated with Yosprala discontinued therapy due to pre-specified upper GI AEs vs EC aspirin3

Rate of discontinuation due to pre-specified upper GI AEs at 6 months3

Help give patients the life-saving benefits of aspirin with Yosprala

*In post-MI patients.
†In post-TIA and stroke patients.
MI, myocardial infarction,
TIA, transient ischemic attack.

SAFETY

Yosprala Safety Profile
Adverse reactions (ARs) that occurred in ≥2% of patients in the Yosprala
arm and were more common than in the control arm2

EC aspirin, 325 mg (n=524)Yosprala, 325 mg/40 mg (n=521)
Gastritis16%18%
Nausea2%3%
Diarrhea2%3%
Gastric polyps1%2%
Noncardiac chest pain1%2%
• 7% discontinuation rate due to ARs with Yosprala (vs 11% with EC aspirin)2

• Less common ARs in Yosprala-treated patients included2
- 2 patients with upper GI bleeding (gastric or duodenal)
- 2 patients with lower GI bleeding (hematochezia and large intestinal hemorrhage)
- 1 patient with obstruction in the small bowel

For a more comprehensive list of adverse events for aspirin or omeprazole,
please refer to the Warnings of their respective Prescribing Information.

AR, adverse reaction, EC, enteric-coated, GI, gastrointestinal.

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


Yosprala® is a registered trademark of Genus Lifesciences, Inc. and is used under license. All other product/brand names are trademarks of their respective owners.
Manufactured for: Innovida Pharmaceutique Corporation © 2019 Innovida Pharmaceutique Corporation, Inc. All rights reserved. INY-01-001, Rev 10/2019