AP Pharma's APF530 ready for submission

California, USA-based specialty pharmaceutical company AP Pharma has reported positive results from a pivotal Phase III study comparing APF530 (sustained-release granisetron) with fellow US drug major Eli Lilly's Aloxi (palonosetron HCl) for the prevention of chemotherapy induced nausea and vomiting.

The multicenter, randomized, observer-blind, actively-controlled, double-dummy, parallel-group trial was structured to compare 5mg and 10mg doses of APF530 with Aloxi in four different assessments: acute and delayed onset CINV after both moderately and highly emetogenic chemotherapy. The 10mg dose of APF530 achieved complete response rates that were numerically higher than Aloxi across all four assessments. The results met the primary endpoint of non-inferiority for three assessments, including moderately emetogenic (acute and delayed onset) and highly emetogenic (acute onset), but did not achieve the primary endpoint of superiority for the highly emetogenic delayed onset assessment. Complete response was defined as the absence of emetic episodes or use of anti-emetic rescue medications during a specified period of time. The company plans to submit a New Drug Application to the Food and Drug Administration during the fourth quarter of 2008.