Pozen has reported positive top-line results from two pivotal Phase 3 clinical trials of PA32540, indicated for the secondary prevention of cardiovascular disease in patients at risk of aspirin-induced ulcers.

PA32540 is a coordinated-delivery tablet combining immediate-release omeprazole, a proton pump inhibitor, layered around pH-sensitive aspirin.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The two Phase 3 pivotal trials were randomised double-blind multi-centre studies in which a total of 1,049 subjects at risk of developing aspirin-associated ulcers were randomly assigned to treatment with either PA32540 or 325mg enteric-coated aspirin once daily.

The studies met the primary endpoint, including a considerable reduction in the cumulative incidence of gastric ulcers following administration of PA32540 versus 325mg enteric-coated aspirin over six months.

The trials also met secondary endpoints, including a reduction in gastroduodenal ulceration as well as a reduction in discontinuation due to upper gastrointestinal adverse events in subjects taking PA32540 compared to 325mg enteric-coated aspirin.

Pozen president and chief executive officer John Plachetka said: “This information is essential to progress our PA32540 partnership discussions for the United States, and to allow us to continue to move forward with our preparations for a third quarter NDA submission for this product candidate.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Pozen is a progressive pharmaceutical company that is now creating a portfolio of cost-effective, evidence-based integrated aspirin therapies designed to enable the full power of aspirin by reducing its GI damage.

The company has already completed the long-term safety study and the two pivotal studies, targeting a New Drug Application submission for Q3 2012.