Horizon Therapeutics Initiates Long-Term Phase 3 Safety Study for Lead Product Candida...( - Ongoing Phase 3 clinical developm...),Health

- Ongoing Phase 3 clinical development program will examine HZT-501 as a

potential new 'GI-friendly' NSAID for mild to moderate pain -

PALO ALTO, Calif., Oct. 8 /PRNewswire/ -- Horizon Therapeutics, Inc., a privately held biopharmaceutical company, today announced that it has initiated a phase 3 follow-on safety study (protocol HZ-CA-304) of its lead product candidate HZT-501, an investigational prescription NSAID (non-steroidal anti-inflammatory drug) designed to be "GI-friendly".

HZT-501 is a proprietary formulation of ibuprofen, the most prescribed NSAID in the United States, combined with famotidine, the most potent H2 receptor antagonist, in a single pill. HZT-501 is specifically designed to provide pain relief while reducing stomach acidity during the peak time of risk for gastric ulceration. In a randomized pilot clinical study published in The New England Journal of Medicine (Taha, et. al May 1996), famotidine was demonstrated to significantly reduce the incidence of gastric and duodenal ulcers vs. placebo when administered together with NSAIDs.

"This study is designed to examine the long-term safety of HZT-501 as part of the overall clinical trial program," said George F. Tidmarsh, M.D., Ph.D., co-founder and chief executive officer of Horizon Therapeutics. "We hope that the trial results offer patients, physicians and regulatory authorities a robust set of data to evaluate HZT-501."

The safety study will support the two ongoing pivotal phase 3 trials involving a total of 1,400 patients with mild-to-moderate pain, including patients with osteoarthritis. Horizon protocols HZ-CA-301 and HZ-CA-303 will evaluate the efficacy and safety of HZT-501 with the primary endpoint being reduction in the risk of development of ibuprofen-associated upper gastrointestinal ulcers in patients who require the use of ibuprofen. The trials began in March 2007, and an NDA is targeted to be filed Q4 2008.

The HZ-CA-304 phase 3 follow-o
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