RxTrials Institute Drug Pipeline Alert

A.P. Pharma’s pivotal Phase III study comparing the efficacy of APF530 (granisetron) with Aloxi for the prevention of chemotherapy-induced nausea and vomiting achieved some positive results, according to the company.

The drug met the primary endpoint of noninferiority for three assessments, including moderately emetogenic (acute and delayed onset) and highly emetogenic (acute onset), but it did not achieve the primary endpoint of superiority for the highly emetogenic delayed onset assessment.

The trial consisted of 1,395 patients treated at 103 centers in the U.S., Poland and India.