Oncology News Updates
Eisai's Oral Aloxi Approved For Chemo-Related Nausea/Vomiting
The Pink Sheet Daily
Aug 26, 2008
Eisai said Aug. 24 that it had obtained FDA approval for an oral capsule formulation of Aloxi (palonosetron) for preventing chemotherapy-induced nausea and voting, broadening the company's reach into the CINV market.
U.S. subsidiary, Eisai Corp. of North America and the treatment's licensor, Helsinn Healthcare SA of Switzerland, won approval for the 5-hydroxytryptamine-3 receptor antagonist for preventing acute nausea and vomiting in patients that receive initial and repeated moderately emetogenic chemotherapy.
Tokyo-based Eisai gained the antiemetic through its acquisition of MGI, which licensed North American marketing and distribution rights to Aloxi from privately held Helsinn.
The new approval is a single 0.5 mg capsule given to patients about one hour before the start of chemotherapy, Eisai said. In Phase II clinical trials, headaches were experienced by 3.7 percent of patients and 0.6 percent had constipation, an Eisai spokesman told PharmAsia News.
Eisai has been distributing Aloxi injection 0.25 mg for both moderately and highly emetogenic chemotherapy since 2003. The Aloxi injectable is the first and only 5-HT3 receptor antagonist for acute and delayed nausea and vomiting associated with initial and repeated chemotherapy, according to Eisai.
In March, FDA approved a 0.075 mg Aloxi injection for post-operative nausea and vomiting in the first 24 hours after surgery.
Of four CINV treatments available in the U.S., GlaxoSmithKline's Zofran (ondansetron) and Roche's Kytril (granisetron) are among comparable treatments. Both are also available in liquid form, an option not offered by Aloxi.
More than half of cancer patients who undergo chemotherapy are known to suffer acute and/or repeated CINV.
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