Additionally, POZEN provided an update on its PA program and the results of its Type A meeting with the FDA last week, wherein the Company indicated that it is currently anticipating an NDA submission in the first half of 2013.
About the Co-Rx Study
The Co-Rx study was a Phase 1, randomized, open-label, two-arm crossover study in which 30 healthy subjects were treated with one of the following: A) PA32540 in the morning plus Plavix
(clopidogrel) (300 mg) over 10 hours later on day 1, and PA32540 in the morning plus clopidogrel (75 mg) 10 hours later on days two through seven; B) enteric-coated aspirin (81 mg) plus clopidogrel (300 mg) plus Prilosec
(EC omeprazole) (40 mg) all in the morning on day 1 followed by enteric-coated aspirin (81 mg) plus clopidogrel (75 mg) plus EC omeprazole (40 mg) all in the morning on days two through seven. Subjects were first randomized to treatment A or treatment B and then crossed over to the alternate treatment. Each treatment was separated by a 14 day washout period.
The primary objective of the study was to assess the effects of PA32540 and EC omeprazole (40 mg) on clopidogrel activity as measured by ex-vivo platelet aggregation using 20 uM adenosine diphosphate (ADP), a commonly used platelet assay of clopidogrel effect.
The primary endpoint was the percent inhibition of platelet aggregation (IPA) after morning dosing on day seven of each period. In the study, PA32540 in the morning, plus clopidogrel 10 hours later, resulted in a significantly greater IPA than enteric-coated aspirin (81 mg) plus EC omeprazole (40 mg) plus clopidogrel all dosed in the morning.
is a registered trademark of Sanofi Aventis Corporation; Prilosec
is a registered trademark of the AstraZeneca AB group of companies.
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.