Today, POZEN presented data from the combined results of two Phase 3 studies of PA32540 in patients with prior cerebrovascular disease. PA32540 is an antiplatelet therapy of enteric-coated (NYSE:EC) and immediate-release omeprazole. Data from the two studies was presented as poster board No. MP103 on Feb. 7 at the American Heart Association 2013 International Stroke Conference in Honolulu, Hawaii.
The studies found that in the post-hoc analysis of subjects with a history of transient ischemic attack (TIA) or stroke, receiving long-term treatment (six months) of PA32540, as compared with EC-ASA (325 mg), was associated with a substantially reduced rate of endoscopic gastroduodenal ulcers (2.0 percent versus 12.4 percent, respectively; p=0.005) as well as a reduction in study discontinuation due to adverse pre-specified upper GI events (0 percent versus 8.0 percent, respectively; p=0.006). The incidence of adjudicated major adverse cardiac events was similar for PA32540 (2.9 percent) and EC-ASA (325 mg) (4.4 percent).
As stated in the AHA guidelines, using an antiplatelet agent, like aspirin, is recommended for reducing the risk of recurrent stroke and other cardiovascular events. Adherence to aspirin therapy saves patients' lives, while discontinuing aspirin increases the likelihood of potential adverse cardiovascular and cerebrovascular events; however, aspirin therapy is often discontinued due to aspirin's adverse GI effects. In these pivotal studies, PA32540 was shown to have a significantly lower incidence of treatment discontinuation than use of aspirin alone.
A progressive pharmaceutical company that is changing the way the healthcare industry addresses unmet medical needs, POZEN has successfully developed and obtained FDA approval for two self-invented products in two years by utilizing an in-source model and focusing on integrated therapies. Funded by these milestone/royalty streams, the company is developing a portfolio of cost-effective, evidence-based integrated aspirin therapies that are designed to reduce the GI damage of aspirin to enable its full treatment power. The company is presently seeking strategic partners to help maximize the opportunity for its portfolio assets.
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