Business Wire – Tue Oct 27 07:30:00 CDT 2009
Results of Phase I Study Show Novel, Investigational PA65020 Compound Significantly Decreased Risk of Upper GI Damage in Healthy Adults
Study Receives a Presidential Award from ACG
CHAPEL HILL, N.C. (BUSINESS WIRE) --
POZEN Inc. (NASDAQ: POZN) announced today the results of a Phase I study that showed a novel, investigational combination of enteric-coated aspirin (EC-ASA) and immediate-release omeprazole known as PA65020, is associated with a significantly decreased risk of GI mucosal damage compared to analgesic doses (650 mg twice daily) of over-the-counter enteric-coated aspirin (EC-ASA) in healthy adults treated for one month. The randomized, double-blind study highlighted that the majority of patients taking over-the-counter EC-ASA experienced significant gastroduodenal damage. The data were presented at the American College of Gastroenterology (ACG) 2009 Annual Scientific Meeting today in San Diego, CA. ACG presented the study with a Presidential Award for winning science.
“These findings are encouraging for the millions of people who require analgesic doses of aspirin but are at risk for upper GI damage as a result of this treatment,” said Dr. John Fort, Chief Medical Officer. “More than five billion units of aspirin in all of its forms are sold in the U.S. each year. Upper GI toxicity is a common complication of aspirin therapy. Even modified-release aspirin formulations do not significantly lower the risk of GI events.”
About the Study
The study examined 20 healthy adults with normal endoscopy, defined as a Grade 0 Lanza score at baseline. Dosing schedules were as follows: PA65020 was administered in two tablets (fixed dose combination of EC-ASA 325 mg and IR omeprazole 20 mg, and EC-ASA 325 mg) twice daily; EC-ASA 650 mg was administered as two 325 mg tablets twice daily. Following 28 days of therapy, 15% of the PA65020 treatment group versus 85% of the EC-ASA treatment group had Grade 3 or 4 Lanza scores (P<0.001), the study’s primary endpoint. In addition, 65% of subjects in the PA65020 group had Grade 0 Lanza scores, meaning no visible gastroduodenal lesions, versus 0% of subjects in the EC-ASA group. An assessment of gastric and/or duodenal ulcers showed that no patients in the PA65020 treatment group versus 40% of those in the EC-ASA treatment group (P=0.003) had evidence of these complications at day 28. No serious adverse events were reported and there were no withdrawals due to adverse events.
POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience. POZEN’s efforts are focused primarily on the development of pharmaceutical products for the treatment of acute and chronic pain and other pain-related conditions. POZEN has development and commercialization alliances with GlaxoSmithKline for Treximet®, which was approved in 2008 by the United States Food and Drug Administration for the acute treatment of migraine attacks, with or without aura, in adults, and with AstraZeneca for VIMOVO™, the proposed trade name for the proprietary fixed dose combination of naproxen with the proton pump inhibitor esomeprazole magnesium in a single tablet for conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID-associated gastric ulcers. The Company has decided to retain control of its aspirin product portfolio and is evaluating how best to commercialize these product candidates. The Company’s common stock is traded on The NASDAQ Stock Market under the symbol “POZN”. For detailed company information, including copies of this and other press releases, see POZEN’s website: www.pozen.com.
Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval of our product candidates, including as a result of the need to conduct additional studies, or the failure to obtain such approval of our product candidates, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of our product candidates; uncertainties in clinical trial results or the timing of such trials, resulting in, among other things, an extension in the period over which we recognize deferred revenue or our failure to achieve milestones that would have provided us with revenue; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products, including our dependence on GlaxoSmithKline for the sales and marketing of Treximet; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events, including those discussed herein and in our Quarterly Report on Form 10-Q for the period ended June 30, 2009. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
Articles appearing above are picked up from Business Wire's feed. Stories from this feed are submitted by companies, edited and rereleased as a service of Business Wire.