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7/28/2003

FDA Approves Antiemetic Aloxi

Kate Traynor

The Food and Drug Administration on Friday approved the marketing of palonosetron hydrochloride injection, or Aloxi, for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy.

Aloxi, a serotonin type-3 receptor (5-HT3) antagonist, is also indicated for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. The product is manufactured by Cardinal Health Inc. and Helsinn Birex Pharmaceuticals and distributed in the United States by MGI Pharma Inc.

During an investors' conference call this morning, MGI President Lonnie Moulder emphasized that palonosetron differs from other 5-HT3-receptor antagonists because "the other agents in the class do not have any indications for delayed nausea and vomiting."

"Aloxi is now the only 5-HT-receptor antagonist indicated for both the prevention of acute and delayed [chemotherapy-induced nausea and vomiting] for patients receiving moderately emetogenic cancer chemotherapy, the most frequently used regimen to treat prevalent cancers such as breast cancers, lung cancers, and colorectal cancers," Moulder said.

He added that MGI plans a mid-September launch for the product.

According to the product's labeling (PDF), palonosetron hydrochloride is supplied as 0.25 mg of the free base in 5 mL of a solution containing 207.5 mg of mannitol in a disodium edetate and citrate buffer. The recommended dosage in adults is 0.25 mg infused intravenously over 30 seconds with no other medication. The infusion line should be flushed with 0.9 percent sodium chloride injection before and after the administration of palonosetron.

In clinical trials, headache and constipation were the most frequent adverse events reported by palonosetron users. The product's labeling describes these events as similar in frequency and severity to those associated with the use of ondansetron or dolasetron, two other 5-HT3-receptor antagonists.