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News Breaks | | | | February 8, 2013 | | 07:34 EDT |  | POZN | POZEN presents PA32540 Phase 3 data
POZEN presented data from the combined results of two Phase 3 studies of PA32540, an antiplatelet therapy of enteric-coated and immediate-release omeprazole, in patients with previous cerebrovascular disease. These data were presented at the American Heart Association 2013 International Stroke Conference. According to the studies, in the post-hoc analysis of subjects with a history of transient ischemic attack or stroke, long-term treatment with PA32540, compared to EC-ASA, was associated with a significantly reduced rate of endoscopic gastroduodenal ulcers, and study discontinuation due to adverse pre-specified upper GI events. The incidence of adjudicated major adverse cardiac events was similar for PA32540 and EC-ASA. Key Findings of the Study: PA32540 is associated with a lower rate of endoscopic gastroduodenal mucosal injury with a similar cerebrovascular event profile as EC-ASA therapy; PA32540, a single tablet containing EC aspirin and IR omeprazole, has a lower rate of discontinuation and, hence, may improve long-term adherence to ASA therapy. | |
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| May 21, 2013 | | 07:44 EDT | | POZN | POZEN says PA32540 resulted in fewer gastric ulcers in trial
POZEN presented the Abstract, Prevalence of Gastric Ulcers in Aspirin Users/Does the Presence of Erosions Foreshadow Ulcer Development, from a post-hoc analysis of Phase 3 data from the investigational compound PA32540. The analysis of patients screened for the Phase 3 studies demonstrated that at any time point, over 4% of subjects on low dose aspirin for cardiovascular and cerebrovascular disease have endoscopic gastric ulcers that go undetected. In addition, the analysis demonstrated that even the presence of small lesions known as endoscopic gastric erosions in aspirin-users was associated with a 2-fold increased risk of future development of endoscopic gastric ulcers. In patients with gastric erosions at baseline, PA32540, a coordinated-delivery tablet combining immediate-release omeprazole, layered around a pH-sensitive coating of a 325 mg ASA core, resulted in significantly fewer gastric ulcers at six months vs. EC-ASA. These data were presented for the first time at Digestive Disease Week 2013 on May 20. | | | May 8, 2013 | | 07:31 EDT |  | POZN | POZEN reports Q1 EPS (19c), consensus (19c)
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