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FDA approves PONV injection

Palonosetron hydrochloride injection, Aloxi, has been given approval for use in postoperative treatment by the US Food and Drugs Administration.

Palonosetron hydrochloride injection, Aloxi, has been given approval for use in postoperative treatment by the US Food and Drugs Administration (FDA).

Aloxi has been developed to prevent postoperative nausea and vomiting (PONV) for a period of 24 hours after completion of surgery.

Developed by Eisai Corporation of North America, its US subsidiary MGI Pharma, and Helsinn Healthcare SA (based in Switzerland), Aloxi has been shown to reduce the severity of PONV.

Hajime Shimizu, chairman and CEO of Eisai North America, said: ìThis new indication is in keeping with our human health care mission to address unmet medical needs of patients.î

The efficacy of Aloxi was established during a double-blind phase III study that saw 547 surgical patients given the injection to stop PONV.

Recent data shows that 40 per cent of all surgical patients will develop symptoms of PONV and that 33 per cent of high-risk patients require rescue therapy.

Aloxi was granted FDA approval after the phase III trail successfully met its co-primary endpoint, meaning that the injection stopped incidences of PONV and cut out the need for rescue therapy.

Dr Michael Cullen, chief medical officer of MGI Pharma, said: ìThese results highlight the unique safety features of Aloxi and when combined with clinical results, indicate a favourable risk/benefit ratio.î

In the US approximately 38 million operations requiring anaesthesia are performed each year and 15 million of these utilise 5-HT3 receptor antagonists, such as Aloxi.

Riccardo Braglia, CEO of Helsinn Healthcare SA, said: ìThis is an important milestone for Aloxi, given the increasing use of antiemetic prophylaxis during surgical procedures.î

Injections of Aloxi have been available in the US since 2003 for the prevention of nausea and vomiting caused by moderate emetogenic chemotherapy, and it is the first 5-hydroxytryptamine (5-HT3) receptor antagonist of its kind with FDA approval.

6th March 2008

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