Swiss pharmaceutical group Helsinn Healthcare SA, together with its partner Eisai Corporation of North America and Eisai’s US subsidiary, MGI Pharma, Inc, have announced that the US Food and Drug Administration (FDA) has approved Aloxi (palonosetron hydrochloride) injection for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.
Aloxi, available in the US since 2003, is the first and only 5-hydroxytryptamine-3 (5-HT3) 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 trial, 574 patients undergoing elective gynecologic or abdominal laparoscopic surgery (predominately in the out-patient setting) were randomised to receive one of three single intravenous doses of the drug or placebo prior to administration of anaesthesia.
The effectiveness of Aloxi in PONV was assessed on the day of surgery (0-24 hours) and for two subsequent days (24-72 hours).
“These results highlight the unique safety features of Aloxi and when combined with the clinical results, indicate a favorable risk/benefit ratio,” said Michael Cullen, MD, Chief Medical Officer, MGI Pharma, Inc.
“This new indication is in keeping with our human health care mission to address the unmet medical needs of patients,” said Hajime Shimizu, Chairman and CEO, Eisai Corporation of North America. “A single intravenous dose of Aloxi can provide anaesthesiologists with an effective option for the prevention of PONV for up to 24 hours.”