The Phase III program is comprised of two trials involving a total of 1,500 patients with mild-to-moderate pain, including patients with osteoarthritis. Horizon Protocol HZ-CA-301 and HZ-CA-303 are evaluating the efficacy and safety of HZT-501 with a primary endpoint of reduction in the risk of development of ibuprofen-associated upper gastrointestinal (gastric and/or duodenal) ulcers in patients who require the use of ibuprofen. The clinical trials are multi-center, randomized, controlled, and blinded for up to 24 weeks of treatment, followed by a 4 week safety evaluation period. The studies are being conducted in the US.
In addition, a Phase III follow-on safety study HZ-CA-304 is underway. The trial is a multi-center, double blind trial that will enroll approximately 200 patients who have participated in the 301 or 303 Phase III trials. Study participants will continue to receive the same study medication they received in the other trials which was either HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) or ibuprofen 800mg. Study participants will receive medication for up to 28 weeks.
George Tidmarsh, co-founder and CEO of Horizon Therapeutics, said: “We look forward to receiving the complete set of clinical results and safety data to review this Fall.”