Horizon settles Ph III US HZT-501 trial design

The USA's Horizon Therapeutics has reached an agreement with the Food and Drug Administration via a Special Protocol Assessment for the Phase III trial program of HZT-501, its gastrointestinal-friendly prescription non-steroidal anti-inflammatory drug for mild-to-moderate pain relief.

The SPA agreement indicates that, if the trials successfully meet their primary endpoint, the data will provide support for an efficacy claim in a marketing application to the FDA. The two trials are expected to begin patient enrollment in the first half of the year.

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, specifically designed to provide pain relief while reducing stomach acidity during the peak time of risk for ulceration.