Phase III study of NEPA (Helsinn and Eisai) meets endpoint in patients with Nausea

Top-line results from a pivotal Phase III clinical study investigating NEPA (netupitant and palonosetron), from Helsinn and Eisai, for chemotherapy-induced Nausea and Vomiting (CINV), shows NEPA has superior complete response rates compared with palonosetron during the delayed phase after chemotherapy administration, which was the primary endpoint of the study. The global, randomized, double-blind, parallel group superiority study was designed to assess the efficacy and safety of a single oral dose of NEPA versus a single oral 0.50 mg dose of PALO in 1455 chemotherapy-naive patients receiving anthracycline-based chemotherapy.

The most frequently reported study drug-related adverse events for NEPA included headache (3.3%) and constipation (2.1%). Helsinn now plans to submit a New Drug Application for NEPA to the FDA and a Marketing Authorisation Application to the EMA for the proposed indication of prevention of acute and delayed CINV.