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Horizon Therapeutics' HZT-501 Significantly Reduces Incidence of NSAID-Induced Upper Gastrointestinal Ulcers in Patients With Mild-to-Moderate Pain
Date:6/1/2009

nd 26.6 mg famotidine) or ibuprofen (800 mg) alone who developed endoscopically diagnosed gastric and/or duodenal ulcers during a 24-week treatment period. The results for each study were analyzed using both life-table and crude-rate statistical methods. Results are listed in the table below:

                REDUCE 1 (n=812)                REDUCE 2 (n=570)

               HZT-501   Ibuprofen   P-value   HZT-501   Ibuprofen   P-value
               (n=550)   (n=262)              (n=380)    (n=190)

    No. of
     patients
     developing
     upper GI
     ulcers        62        61                    40        38
    Life Table
     Analysis(%) 14.7      29.1    0.0002        13.8      22.6       0.0304
    Crude Rate
     Analysis(%) 11.3      23.3    0.0001        10.5        20       0.0018

Treatment with HZT-501 was well-tolerated. The most commonly reported adverse events in these two studies were dyspepsia, nausea, diarrhea, constipation, headache and upper respiratory tract infection. The majority were mild to moderate in severity. There were no significant differences in adverse event or serious adverse event profiles between the two treatment groups. One death occurred in the ibuprofen group due to an overdose of Tylenol(R).

"Patients treated with HZT-501 were approximately half as likely to develop upper GI ulcers compared to patients treated with ibuprofen alone," said Timothy P. Walbert, president and chief executive officer of Horizon Therapeutics. "These data provide compelling evidence for the promise of HZT-501 in treating patients with mild to moderate pain who are at risk for upper GI ulcers."

NSAIDs, such as ibuprofen, are among the most widely used drugs in the world for the treatment of chronic pain and inflammation with more than 90 million prescriptions written each year for the treatment of arthritis and other types of mild-to-moderate pain.
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SOURCE Horizon Therapeutics, Inc.
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