POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, presented positive results from two pivotal Phase 3 clinical trials of the investigational product, PA32540, at The American Heart Association (AHA) Scientific Sessions 2012, as Poster #12057: Treatment Continuation and Cardiovascular Safety of Antiplatelet Therapy with PA32540, A Tablet with Enteric-Coated Aspirin and Immediate-Release Omeprazole: Results of Two 6-Month, Phase 3 Studies. Each study achieved its individual primary endpoint, as patients on PA32540 experienced fewer gastric ulcers compared to those taking enteric-coated aspirin (325 mg) alone. Data for the primary endpoint are shown below:
"The results of these Phase 3 pivotal studies are promising and report the important role that PA32540 may play in the long-term management of cardiovascular protection," said Chris O'Connor, M.D., Director, Duke Heart Center, Duke University Hospital and one of the authors of the studies. "Discontinuation of aspirin therapy is often due to the adverse GI effects of aspirin. In these pivotal studies, PA32540 was associated with a significantly lower rate of treatment discontinuation than aspirin alone. Patient adherence to aspirin therapy saves lives, as aspirin discontinuation increases the likelihood of potential adverse cardiovascular events."
A summary of discontinuation rates of the combined data are shown below:
In addition, the results from the combined data from the two studies demonstrated that patients on PA32540, compared to those on enteric-coated aspirin (325 mg), were able to stay on therapy longer due to fewer discontinuations to any adverse events (6.7% vs. 11.2%).
In the combined data from the two trials, 85.1% of subjects on enteric-coated aspirin (325 mg) reported adverse events compared to 71.8% of subjects on PA32540. The most commonly reported adverse events with PA32540 and enteric-coated aspirin (325 mg) were of the GI tract and include dyspepsia (11.3% vs. 30.2%), erosive gastritis (11.5% vs. 26.3%), and gastritis (17.5% vs. 16.0%) respectively. The incidence and nature of adjudicated Major Adverse Cardiac Events (MACE) such as heart attacks was similar between the 2 treatment arms: 9 subjects (1.7%) on PA32540 experienced adjudicated MACE compared to 13 subjects (2.5%) on aspirin (325 mg). Please see the complete AHA poster, available at www.pozen.com, for more detail of the study results.
"Aspirin is often recommended for the secondary prevention of cardiovascular events; however, it also can be a contributing factor to the development of gastric ulcers as well as abdominal discomfort (dyspepsia) and other troublesome upper GI tract symptoms," said Dr. Jay L. Goldstein, Vice Chairman of the Department of Medicine, and Head of the Division of Gastroenterology at NorthShore University Health System as well as one of the authors of the studies. "In these two randomized trials, the use of the combination product PA32540 was associated with fewer gastric ulcers and a lower rate of dyspepsia and other upper GI tract symptoms than aspirin alone. With a reduction of these symptoms, patients can be provided the option of an overall better-tolerated therapy for ongoing secondary prevention of cardiovascular events."
The two Phase 3, double-blind, randomized, multicenter studies enrolled 1,049 subjects who were prescribed daily aspirin (325 mg) for greater than or equal to three months for secondary prevention of cardiovascular events. The primary endpoint was the cumulative observed incidence of gastric ulcers over six months. Secondary endpoints included cumulative incidence of gastric and duodenal ulcers, discontinuation due to pre-specified UGI adverse events and heartburn resolution. Subjects were randomly assigned to once-daily treatment with PA32540 or 325 mg of enteric-coated aspirin. Endoscopic assessments were performed at screening and at one, three and six months. Major adverse cardiac events were reviewed and adjudicated by an independent, blinded endpoint committee composed of Cardiologists.
Cardiovascular disease is the leading cause of death in the United States, and there are currently 24 million secondary prevention patients, most of whom are on a daily aspirin therapy. However, approximately 15 percent of people on low-dose aspirin are at risk for upper GI adverse events, and 12 percent discontinue or reduce intake due to these serious UGI side effects.
Additional data from the two pivotal Phase 3 PA32540 trials recently were presented at the American College of Gastroenterology 2012 Annual Meeting. For more detail of the study results, please see www.pozen.com for the complete poster.