Horizon Therapeutics Announces Two Pivotal HZT-501 Phase 3 Trials Meet Primary Endpoints

Wednesday, December 3, 2008 General News
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SKOKIE, Ill., Dec. 2 Horizon Therapeutics, Inc., aprivately held biopharmaceutical company, today announced that two pivotalPhase 3 trials evaluating its lead investigational product candidate, HZT-501,met all primary endpoints. HZT-501, a novel, proprietary fixed-dosecombination product containing ibuprofen and famotidine, demonstrated astatistically significant reduction in the incidence of non-steroidalanti-inflammatory drug (NSAID)-induced upper gastrointestinal (gastric and/orduodenal) ulcers in patients with mild-to-moderate pain when compared toibuprofen alone.

NSAIDs such as ibuprofen are among the most widely used drugs in theworld. However, NSAIDs are associated with a range of adverse side effects,which primarily affect the gastrointestinal (GI) tract. Up to 30 percent ofpatients taking NSAIDs experience gastrointestinal ulcers and a greaterpercent suffer from upper GI symptoms (i.e., dyspepsia, heartburn).

"NSAIDs, while highly effective in treating pain and inflammation, oftenlead to serious safety concerns, including significant gastrointestinaldamage," said Timothy P. Walbert, president and chief executive officer,Horizon Therapeutics. "We are committed to bringing this much needed treatmentto physicians and patients as quickly as possible and plan on submitting thesestrong HZT-501 Phase 3 results to U.S. and European regulatory authorities in2009."

REDUCE-1 and REDUCE-2 Trial Design and Results

The Registration Endoscopic Study to Determine Ulcer Formation of HZT-501Compared to Ibuprofen: Efficacy and Safety Study (REDUCE-1 and REDUCE-2) weretwo randomized, double-blind, controlled trials that enrolled more than 1,500patients in the United States. The primary efficacy objective of REDUCE-1 wasto evaluate HZT-501 in reducing the proportion of patients who developendoscopically diagnosed gastric ulcers during the 24-week treatment period,as compared to ibuprofen, in patients at risk for NSAID-induced ulcers. Theprimary objective of REDUCE-2 was to evaluate HZT-501 in reducing theproportion of patients who develop endoscopically diagnosed gastric and/orduodenal ulcers during the 24-week treatment period, as compared to ibuprofen,in patients at risk for NSAID-induced ulcers. The trials were conducted via aSpecial Protocol Assessment (SPA) with the U.S. Food and Drug Administration(FDA).

Patients, who had mild-to-moderate pain, including those withosteoarthritis, were randomly assigned, in approximately a 2:1 ratio, toreceive HZT-501 (800 mg ibuprofen and 26.6 mg famotidine) or ibuprofen (800mg) alone orally three times daily for a 24- week treatment period or untilpatients developed either an endoscopically diagnosed upper gastrointestinalulcer and/or prohibitive toxicity. Patients received endoscopies at baselineand weeks 8, 16 and 24. 8025 Lamon Avenue, Suite 110, Skokie, IL 60077

In REDUCE-1, 24-week treatment with HZT-501 resulted in a statisticallysignificant reduction in gastric ulcers versus treatment with ibuprofen alone.In REDUCE-2, 24-week treatment with HZT-501 resulted in a statisticallysignificant reduction in gastric and/or duodenal ulcers versus treatment withibuprofen alone.

Treatment with both HZT-501 and ibuprofen alone were well tolerated in thestudies. The majority were mild to moderate in severity. There were nosignificant differences between the two treatment groups adverse event orserious adverse event profiles.

"NSAIDs can cause significant gastrointestinal damage, including ulcers ofthe stomach and duodenum," said Loren Laine, MD, professor of medicine,Division of Gastrointestinal and Liver Diseases, Keck School of Medicine,University of Southern California. "These results indicate that HZT-501 canreduce the risk of ulcers, potentially improving the GI safety for patientstreated with NSAIDs."

About HZT-501

HZT-501 is a novel, proprietary fixed-dose combination formulation of theworld's most prescribed NSAID, ibuprofen, with a high dose of the most potentH2 antagonist, famotidine (Pepcid(R)), in a single pill. It is anticipatedthat HZT-501 will provide effective pain relief and reduce stomach acidityduring the peak time of ulceration risk, thus reducing the risk ofNSAID-induced ulcers. HZT-501 has completed Phase 3 trials and the Companyexpects to submit a new drug application (NDA) to the U.S. federal drugadministration (FDA) and a marketing authorization application (MAA) to theEuropean Medicines Agency (EMEA) in the second half of 2009.

About the Arthritis and Pain Market

According to the Arthritis Foundation, arthritis affects 46 million peoplein United States and costs the U.S. economy $128 billion annually. Accordingto a study by the Centers for Disease Control and Prevention (CDC) for theNational Arthritis Data Workgroup, due to the increasing aging population,arthritis is projected to increase by 40 percent in the next two decades. TheCDC estimates that 67 million people will be affected by arthritis by 2030.Additionally, chronic pain affects an estimated 86 million American adults.NSAIDs are among the most widely used drugs in the world for the treatment ofarthritis and pain and are a major cause of gastrointestinal complications,including ulcers. NSAIDs block enzymes and reduce prostaglandins throughoutthe body and as a consequence, ongoing inflammation, pain, and fever arereduced. Since the prostaglandins that protect the stomach are reduced, NSAIDsoften cause ulcers in the stomach. NSAID-induced GI toxicity causes anestimated 16,500 deaths and more than 107,000 hospitalizations annually in theUnited States alone.

If deaths from the gastrointestinal effects of NSAIDs were tabulatedseparately in the National Vital Statistics reports, these effects wouldequate to the 15th most common cause of death in the United States. Studieshave shown that less than 30 percent of high-risk NSAID patients areco-prescribed a gastro-protective agent in combination with their NSAID. Inaddition, patient adherence to a regimen of separate pain and GI protectivemedications has also been shown to be poor. 8025 Lamon Avenue, Suite 110,Skokie, IL 60077

About Horizon Therapeutics

Horizon Therapeutics, Inc. is a late-stage biopharmaceutical companyfocused on the development and commercialization of therapies for thetreatment of mild-to-moderate pain and arthritis. Horizon's clinical portfolioincludes innovative combination therapies in early- and late-stage developmentthat are designed to improve safety, efficacy and patient compliance. For moreinformation about the company and its products, please visithttp://www.horizontherapeutics.com.

SOURCE Horizon Therapeutics, Inc.

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