This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

PA32540 Provides Faster Gastric Acid Reduction Than Enteric-Coated Omeprazole (40 Mg)

POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, presented data today from a Phase 1 study that found that the investigational compound, PA32540, provides faster protection compared with delayed-release, enteric-coated omeprazole (40 mg), as measured by mean time to gastric pH. These data were presented for the first time at Digestive Disease Week (DDW) 2012 in San Diego, California at the San Diego Convention Center on May 19, 2012, at 9:15 a.m. (PT).

“In this study, the mean time to a gastric pH of greater than 4.0 was faster with PA32540 than with 40 mg of delayed-release, enteric-coated omeprazole,” said Philip B. Miner, Jr., M.D., President and Medical Director of the Oklahoma Foundation for Digestive Research and co-author of the study. “In addition, the 24-hour pH control achieved with the immediate release form of omeprazole in PA32540 should be sufficient for control of gastric acidity in patients taking chronic aspirin therapy for secondary cardiovascular prevention.”

About Study 112

Study 112 is a Phase 1, single-center, open-label, randomized, two-way crossover study that examined 26 healthy male and female volunteers who were H. pylori negative. The study rationale was to gain an understanding of the anti-secretory and gastrointestinal (GI) therapeutic effect of the immediate-release omeprazole in PA32540. Subjects received either PA32540 once daily for seven days or enteric-coated aspirin (325 mg) plus enteric-coated omeprazole (40 mg) administered concomitantly once daily for seven days. After at least a seven-day washout, subjects were crossed over to the alternate treatment. Gastric pH and pharmacokinetics were measured over 24 hours on day seven of each treatment period.

Key Findings
  • Mean time to first gastric pH >4 was significantly faster with PA32540 compared to the enteric-coated aspirin + enteric-coated omeprazole group (PA32540: 17 minutes; enteric-coated aspirin + enteric-coated omeprazole: 36 minutes; p=0.011).
  • The percent time gastric pH >4 was 50.6 percent for PA32540 and 57.6 percent for enteric-coated aspirin + enteric-coated omeprazole group (p=0.004).
  • The relative bioavailability of omeprazole following seven daily doses with PA32540 was 43 percent lower than that from enteric-coated omeprazole 40 mg.

“In patients who require aspirin therapy and are at risk for UGI events, PA32540 could provide a consistent and coordinated therapeutic approach to cardio protection and reduced risk of UGI injury,” said John G. Fort, M.D., Chief Medical Officer of POZEN and co-author of the study. “These Phase 1 study findings support the coordinated-release design of PA32540, with the omeprazole in the outer layer of the tablet released first followed by aspirin. The Phase 3 top-line results of PA32540 support the gastro protective effects of PA32540.”

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $93.24 -0.41%
FB $117.81 -0.21%
GOOG $701.43 0.82%
TSLA $211.53 -4.96%
YHOO $36.94 2.61%


Chart of I:DJI
DOW 17,660.71 +9.45 0.05%
S&P 500 2,050.63 -0.49 -0.02%
NASDAQ 4,717.0940 -8.5450 -0.18%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs