Horizon to Study NSAID With Decreased Ulcer Risk

Horizon Therapeutics announced that it has begun its Phase III trial program for HZT-501, a nonsteroidal anti-inflammatory drug (NSAID) for mild-to-moderate pain relief. Enrollment has been opened and the first patient has initiated dosing.

HZT-501 is a proprietary formulation of the world's most prescribed NSAID, ibuprofen, combined with the most potent H2 receptor antagonist famotidine in a single pill. HZT-501 is specifically designed to provide pain relief while reducing stomach acidity during the peak time of risk for ulceration. In a randomized pilot clinical study published in the New England Journal of Medicine, famotidine was demonstrated to significantly reduce the incidence of gastric and duodenal ulcers compared with placebo when administered together with NSAIDs, the company said.

"Given the well known gastrointestinal side effects of NSAIDs, there is a clear need for a product like HZT-501," Alan Kivitz, a principal investigator for one of the trials, said.

The two Phase III studies for HZT-501 are being conducted via a special protocol assessment with the FDA. The agreement indicates that if the trials successfully meet their primary endpoint, the data will provide support for an efficacy claim in submitting an application to the FDA.

The two trials in the Phase III clinical program will involve a total of 1,200 patients with mild-to-moderate pain, including patients with osteoarthritis. The studies will evaluate the efficacy and safety of HZT-501 with the primary efficacy endpoint being reduction in the risk of development of ibuprofen-associated upper gastrointestinal ulcers.