POZEN Inc. (NASDAQ: POZN) announced that results of a Phase 1 Trial of PA65020, a combination of enteric-coated aspirin (EC-ASA) and immediate-release (IR) omeprazole, show PA65020 significantly reduces the incidence of gastrointestinal (GI) mucosal damage compared to EC-ASA (650 mg twice daily) in healthy adults treated for one month. Patients receiving analgesic doses of EC-ASA were five times more likely to experience significant GI mucosal damage than patients receiving PA65020. The study concluded that PA65020 may provide an important therapeutic option for at-risk patients who require analgesic doses of aspirin. Data will be presented on May 7th at the 29th Annual Scientific Meeting of the American Pain Society (APS) in Baltimore, MD, being held May 6-8. Data will also be included in a supplemental issue of the Journal of Pain.
The benefits of aspirin are well-documented and more than five billion units of aspirin in all of its forms are sold in the U.S. each year. But because aspirin is linked with significant GI damage, it may be underutilized for both secondary prevention of cardiovascular disease as well as pain. "We are pleased to report that PA65020 reduces the incidence of upper GI damage compared to aspirin therapy," said Dr. John Fort, Chief Medical Officer, POZEN. "These results are promising for the millions of people who could benefit from analgesic doses of aspirin therapy, but are at risk for upper GI damage from this treatment."
About the Study
The study examined 40 healthy adults with normal gastroduodenal endoscopy, defined as a Grade 0 Lanza score, at baseline. Dosing schedules were as follows: PA65020 (fixed dose combination of EC-ASA 325 mg and IR omeprazole 20 mg, and EC-ASA 325 mg) was administered as two tablets twice daily; EC-ASA 650 mg was administered as two 325 mg tablets twice daily. On day 28 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. In addition, no patients in the PA65020 treatment group developed a gastric/duodenal ulcer versus 8 patients (40%) of those in the EC-ASA treatment group (P=0.003) at day 28. No serious adverse events were reported and there were no withdrawals due to adverse events in either treatment arm.
About PA65020
PA65020 is part of the PA franchise under development by POZEN. The PA products utilize a patented technology, developed by POZEN, which allows for sequential release of the active components and protects the stomach in advance of the release of the gastric offending agent. This same proven technology is the basis for VIMOVO™, (naproxen and esomeprazole magnesium) delayed-release tablets, approved by the Food and Drug Administration (FDA) on April 30, 2010 for the relief of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) and to decrease the risk of gastric ulcers in patients at risk of developing non-steroidal anti-inflammatory drug (NSAID) associated ulcers. VIMOVO is co-developed by POZEN and AstraZeneca. POZEN's safer form of aspirin, the PA franchise, has the potential to expand the use of aspirin by significantly improving the tolerability and reducing the risk of GI toxicity issues associated with aspirin therapy.
Source: POZEN Inc.
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