Eisai/MGI's Aloxi gets expanded indication

The US Food and Drug Administration has approved Aloxi (palonosetron HCl) injection for the prevention of post-operative nausea and vomiting for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated, noted the makers of the agent, Japan's Eisai and local firm MGI Pharma.

Aloxi, available in the USA since 2003, is the first and only 5-hydroxytryptamine-3 receptor antagonist approved by the FDA for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately-emetogenic chemotherapy, and for the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy.

The new indication is based on one double-blind Phase III study that evaluated the efficacy of three doses of Aloxi compared to placebo for the prevention of PONV. In the 574-patient trial, the agent successfully met its co-primary endpoint of Complete Response - defined as no vomiting or use of rescue medication - for the 0-24-hour time period. 42.8% of patients treated with the approved dose of Aloxi 0.075mg experienced a CR, compared to 25.9% of subjects given placebo (p=0.0035). For the co-primary endpoint of CR for the 24-72-hour postoperative period, 48.6% of patients treated with Aloxi 0.075 mg experienced a CR, compared to 40.7% given placebo (p=0.1877, not significant). Aloxi 0.075mg also reduced the severity of nausea compared to placebo, and this was supported by Phase II PONV trial results demonstrating that the drug significantly reduced the severity of nausea compared to placebo (p=0.009).