Chicago, IL – June 2, 2009 – New data presented today on the gastric acid suppression of investigational drug PN400 report that the formulation that combined an immediate release (IR) proton pump inhibitor (PPI) (esomeprazole 20 mg) with enteric coated (EC) naproxen (500 mg), dosed twice daily, demonstrated a mean percentage of time with intra-gastric pH >4.0 over 24 hours on Day 9 of 71.35 percent (SD = 13.01), compared with 56.85 percent (SD= 10.06) for 500 mg naproxen + 20 mg (EC) esomeprazole dosed once daily. PN400 is an investigational compound being co-developed by AstraZeneca and POZEN, Inc. that combines the pain reliever naproxen, a non-steroidal anti-inflammatory drug (NSAID), with the PPI esomeprazole in a fixed dose combination tablet. It is under investigation for the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients who are at risk of developing NSAID-associated gastric ulcers. These data were presented today at the annual Digestive Disease Week? (DDW?) in Chicago, IL.
The most common (= 10 percent) adverse events reported with PN400 were headache, diarrhea, abdominal pain, and iron deficiency. Administration of PN400 containing 30, 20 or 10 mg IR esomeprazole did not result in any unexpected adverse events in 9-day, twice-daily treatment periods in healthy subjects.
ABOUT THE STUDY:
The PN400 104 study was a prospective, randomized, open-label, 9-day, 4-way crossover, single-center study that enrolled 28 healthy H. pylori-negative adults without a history of peptic ulcer/acid-related gastrointestinal symptoms. Subjects were randomized to receive either PN400/E30 (EC naproxen 500 mg/IR esomeprazole 30 mg) twice-daily; PN400/E20 (EC naproxen 500 mg/IR esomeprazole 20 mg) twice-daily; PN400/E10 (EC naproxen 500 mg/IR esomeprazole 10 mg) twice-daily; or E20 (EC esomeprazole 20 mg) once-daily plus naproxen 500 mg twice-daily.
ABOUT PN400:
PN400 is an investigational compound under development by AstraZeneca and Pozen, Inc. that combines enteric-coated naproxen and immediate release esomeprazole in a fixed dose combination tablet. Results of the pivotal PN400-301/302 studies were announced in December 2008. AstraZeneca and POZEN plan to submit a New Drug Application (NDA) to the FDA for PN400 in mid-2009.
ABOUT ASTRAZENECA:
AstraZeneca (NYSE: AZN) is engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and in the supply of healthcare services. AstraZeneca is one of the world’s leading pharmaceutical companies with global healthcare sales of $ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.5 billion dollar healthcare business.
For more information about AstraZeneca in the US or our AZ& please?Prescription Savings programs, Me visit: www.astrazeneca-us.com.
