HONOLULU, HW, USA I February 8, 2013 I POZEN Inc. (POZN), a pharmaceutical company committed to transforming medicine that transforms lives, presented data today from the combined results of two Phase 3 studies of PA32540, an antiplatelet therapy of enteric-coated (EC) and immediate-release omeprazole, in patients with previous cerebrovascular disease. These data were presented at the American Heart Association 2013 International Stroke Conference on Thursday, February 7 at 4:15 p.m. (HST) in Honolulu, Hawaii at the Hawaii Convention Center as poster board number MP103.
According to the studies, in the post-hoc analysis of subjects with a history of transient ischemic attack (TIA) or stroke, long-term (6 months) treatment with PA32540, compared to EC-ASA (325 mg), was associated with a significantly reduced rate of endoscopic gastroduodenal ulcers (2.0% vs. 12.4% respectively; p=0.005), and study discontinuation due to adverse pre-specified upper GI events (0% vs. 8.0% respectively; p=0.006). The incidence of adjudicated major adverse cardiac events was similar for PA32540 (2.9%) and EC-ASA (325 mg) (4.4%).
“Discontinuation of aspirin therapy is often due to the adverse GI effects of aspirin,” said Mark J. Alberts, MD, UT Southwestern Medical Center, Dallas, Texas. “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 and cerebrovascular events.”
AHA guidelines state that the use of an antiplatelet agent, such as aspirin, is recommended to reduce risk of recurrent stroke and other cardiovascular events.
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.
About the Study
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. MACE were reviewed and adjudicated by an independent, blinded endpoint committee composed of Cardiologists.
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 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).
For the abstract a post-hoc analysis of the intent-to-treat subpopulation, (n=102) from the PA32540 group and (n=113) from the EC-ASA group, with a history of one or more TIA, ischemic stroke and/or other cerebrovascular disease was analyzed. Treatments were compared using a Cochran-Mantel-Haenzel test.
About Antiplatelet Therapy
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% of people on low-dose aspirin are at risk for upper GI adverse events, and 12% discontinue or reduce intake due to these serious UGI side effects.
Additional data from the two pivotal Phase 3 PA32540 trials were recently presented at the American Heart Association Scientific Sessions 2012 and the American College of Gastroenterology 2012 Annual Meeting. For more detail of the study results, please see www.pozen.com for the complete poster.
About PA
POZEN is creating a portfolio of integrated aspirin therapies – the PA product platform. The products in the PA portfolio are intended to significantly reduce GI ulcers and other GI complications compared to taking aspirin alone.
The first candidates are PA32540, containing 325 mg of aspirin, and PA8140, containing 81 mg of aspirin. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around pH-sensitive aspirin. This novel, patented product is administered orally once a day and an indication will be sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers.
About POZEN
POZEN Inc. is a progressive pharmaceutical company that is transforming how the healthcare industry addresses unmet medical needs. By utilizing a unique in-source model and focusing on integrated therapies, POZEN has successfully developed and obtained FDA approval of two self-invented products in two years. Funded by these milestone/royalty streams, POZEN is now creating a portfolio of cost-effective, evidence based integrated aspirin therapies designed to enable the full power of aspirin by reducing its GI damage.
POZEN is currently seeking strategic partners to help maximize the opportunity for its portfolio assets.
SOURCE: POZEN
Post Views: 277
HONOLULU, HW, USA I February 8, 2013 I POZEN Inc. (POZN), a pharmaceutical company committed to transforming medicine that transforms lives, presented data today from the combined results of two Phase 3 studies of PA32540, an antiplatelet therapy of enteric-coated (EC) and immediate-release omeprazole, in patients with previous cerebrovascular disease. These data were presented at the American Heart Association 2013 International Stroke Conference on Thursday, February 7 at 4:15 p.m. (HST) in Honolulu, Hawaii at the Hawaii Convention Center as poster board number MP103.
According to the studies, in the post-hoc analysis of subjects with a history of transient ischemic attack (TIA) or stroke, long-term (6 months) treatment with PA32540, compared to EC-ASA (325 mg), was associated with a significantly reduced rate of endoscopic gastroduodenal ulcers (2.0% vs. 12.4% respectively; p=0.005), and study discontinuation due to adverse pre-specified upper GI events (0% vs. 8.0% respectively; p=0.006). The incidence of adjudicated major adverse cardiac events was similar for PA32540 (2.9%) and EC-ASA (325 mg) (4.4%).
“Discontinuation of aspirin therapy is often due to the adverse GI effects of aspirin,” said Mark J. Alberts, MD, UT Southwestern Medical Center, Dallas, Texas. “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 and cerebrovascular events.”
AHA guidelines state that the use of an antiplatelet agent, such as aspirin, is recommended to reduce risk of recurrent stroke and other cardiovascular events.
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.
About the Study
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. MACE were reviewed and adjudicated by an independent, blinded endpoint committee composed of Cardiologists.
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 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).
For the abstract a post-hoc analysis of the intent-to-treat subpopulation, (n=102) from the PA32540 group and (n=113) from the EC-ASA group, with a history of one or more TIA, ischemic stroke and/or other cerebrovascular disease was analyzed. Treatments were compared using a Cochran-Mantel-Haenzel test.
About Antiplatelet Therapy
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% of people on low-dose aspirin are at risk for upper GI adverse events, and 12% discontinue or reduce intake due to these serious UGI side effects.
Additional data from the two pivotal Phase 3 PA32540 trials were recently presented at the American Heart Association Scientific Sessions 2012 and the American College of Gastroenterology 2012 Annual Meeting. For more detail of the study results, please see www.pozen.com for the complete poster.
About PA
POZEN is creating a portfolio of integrated aspirin therapies – the PA product platform. The products in the PA portfolio are intended to significantly reduce GI ulcers and other GI complications compared to taking aspirin alone.
The first candidates are PA32540, containing 325 mg of aspirin, and PA8140, containing 81 mg of aspirin. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around pH-sensitive aspirin. This novel, patented product is administered orally once a day and an indication will be sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers.
About POZEN
POZEN Inc. is a progressive pharmaceutical company that is transforming how the healthcare industry addresses unmet medical needs. By utilizing a unique in-source model and focusing on integrated therapies, POZEN has successfully developed and obtained FDA approval of two self-invented products in two years. Funded by these milestone/royalty streams, POZEN is now creating a portfolio of cost-effective, evidence based integrated aspirin therapies designed to enable the full power of aspirin by reducing its GI damage.
POZEN is currently seeking strategic partners to help maximize the opportunity for its portfolio assets.
SOURCE: POZEN
Post Views: 277
