A Special Protocol Assessment for the Phase 3 trial program of HZT-501, Horizon Therapeutics, Inc.’s "GI-friendly" prescription NSAID for mild-to-moderate pain relief has just been approved by the USFDA.
An SPA agreement means that if the trial data turned positive and successful, the data generated can be used to support the company’s efficacy claim in its marketing application to the USFDA.
HZT-501 is a proprietary formulation of the world's most prescribed non-steroidal anti-inflammatory drug (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.
Patient enrolment in the said trials is expected to commence in the first half of the year.
Find more details from the press release.
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