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news.A.P. Pharma, a specialty pharmaceutical company, has announced patient-satisfaction data from Phase 3 APF530 study conducted in patients with chemotherapy-induced nausea and vomiting (CINV).
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The APF530 offered a comparable nausea control and patient satisfaction to palonosetron (Aloxi) over a five-day period with no statistically significant differences in the multicenter, randomized, observer-blind trial.
A.P. Pharma president and chief executive officer John Whelan said the data indicate that APF530 has the potential to provide both comparable antiemetic effects and patient satisfaction results to palonosetron.
"Our continued analysis of the Phase 3 study further demonstrates the potential role APF530 could play as a new therapeutic agent in cancer care," Whelan added.
The actively-controlled, double-dummy, parallel group study stratified patients into two groups, one receiving moderately and the other receiving highly emetogenic chemotherapeutic agents in accordance with the Hesketh algorithm.
APF530 was comparable to palonosetron in preventing both acute- and delayed-onset CINV in patients receiving either moderately emetogenic chemotherapy or highly emetogenic chemotherapy.