 |
 |
Aloxi® (palonosetron hydrochloride) Injection is a potent, highly selective 5-HT3 receptor antagonist developed for the prevention of chemotherapy-induced nausea and vomiting (CINV). Approved by the U.S. Food and Drug Administration (FDA) on July 25, 2003 and commercially launched in September 2003, Aloxi is the first and only 5-HT3 receptor antagonist to be indicated for the prevention of both acute and delayed CINV caused by moderately emetogenic chemotherapy. |
Aloxi® is the first and only 5-HT3 receptor antagonist to be indicated for the prevention of both acute and delayed CINV caused by moderately-emetogenic chemotherapy.
Aloxi is differentiated from other 5-HT3 receptor antagonists due to its strong receptor binding affinity and extended plasma half-life (approximately 40 hours). Results from phase 3 clinical trials demonstrate that a single IV dose of Aloxi is effective in preventing both acute and delayed CINV in patients receiving moderately emetogenic chemotherapy, the most common chemotherapy regimens used in the treatment of cancer. A single intravenous dose of Aloxi can prevent CINV for up to five days following chemotherapy.
Three multicenter, double blind, phase 3 trials compared the efficacy and safety of Aloxi with that of currently marketed 5-HT3 receptor antagonists for prevention of CINV. Study endpoints in each trial included complete response, defined as the percentage of patients that did not experience vomiting or use rescue medication, during the 0-24, 24-120, and 0-120 hour periods following chemotherapy. Approximately 1,800 patients were enrolled in the phase 3 Aloxi clinical program. Results of these trials were presented at the 2003 annual meeting of the American Society of Clinical Oncology (ASCO) and the 2002 and 2003 Multinational Association of Supportive Care in Cancer (MASCC) International Symposia.
Adverse reactions observed in the pivotal trials were similar in frequency, intensity, and duration with Aloxi as with the active comparator agents. The most common adverse reactions were headache (9%) and constipation (5%).
Licensed from Helsinn Healthcare SA of Lugano, Switzerland, MGI PHARMA holds exclusive U.S. and Canadian license and distribution rights to Aloxi. For more information about Aloxi, please visit www.aloxi.com.
About Chemotherapy Induced Nausea and Vomiting
Chemotherapy induced nausea and vomiting is a common side effect experienced by many cancer patients who are receiving chemotherapy. If not prevented, approximately 70%-80% of all cancer patients receiving chemotherapy may experience CINV. CINV can result in delay of chemotherapy or even discontinuation of treatment. The market in the United States for 5-HT3 receptor antagonists used for the prevention of CINV approximates $1 billion annually.