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| |  Palonosetron's Benefit/Risk Profile Confirmed as Favorable in Postmarket Studies: Presented at MASCC-ISOO By Paula Moyer GENEVA, SWITZERLAND -- July 8, 2005 -- Palonosetron hydrochloride (Aloxi, Onicit) a 5-HT3 receptor antagonist that is used to control chemotherapy-induced nausea and vomiting continues to show a favorable tolerability profile, according to findings presented here July 1st. Principal investigator Franco Bissoli, MD, attending oncologist, Clinica San Gaudenzio, Novara, Italy, presented a review of postmarketing surveillance data at the Multinational Association of Supportive Care in Cancer (MASCC)/International Society for Oral Oncology (ISOO) 17th International Symposium. "With approximately 1.3 million doses administered, the postmarketing surveillance spontaneous data show a favorable safety profile," he said in an interview. Among these patients, 81 adverse events (0.0061%) have been reported, primarily headache, hypersensitivity, and injection site discomfort, he said. Further, 21 patients (0.0016%) reported lack of efficacy. The investigators wanted to document patients' response to palonosetron after its approval because during clinical development, its safety profile was similar to other serotonin receptor antagonists, with headache and constipation listed as the class's most frequently reported adverse effects. Dr. Bissoli and colleagues reviewed postmarketing surveillance data covering the period from September 2003 to January 2005, in which patients received a total of 1.324 million doses of palonosetron. Of the 81 adverse events, most were mild, 13 instances of headache, 8 hypersensitivity reactions, and 8 instances of injection site burning or discomfort. No treating physician reported an instance of QT interval prolongation. The researchers found 1 case of constipation that was mild. The surveillance data "indirectly confirm" that palonosetron has a positive benefit-risk profile consistent with the findings seen in clinical trials, according to Dr. Bissoli. Palonosetron is comarketed by MGI Pharma and Helsinn. It is marketed as Aloxi in the United States and as Onicit in Europe. It is indicated for prevention of acute nausea and vomiting associated with moderately and highly emetogenic chemotherapy, and prevention of delayed nausea and vomiting associated with moderately emetogenic chemotherapy.
[Presentation title: Post-Marketing Experience of Palonosetron Confirms a Favorable Benefit/Risk Profile. Abstract 04-017]
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