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Published on 11/17/2005 in the Prospect News Biotech Daily.

Hana Biosciences' oral anti-nausea spray Zensana absorbs more quickly than Zofran tablets, study shows

By Angela McDaniels

Seattle, Nov. 17 - Hana Biosciences said a preclinical in vivo pharmacokinetic study in dogs demonstrated the enhanced bioavailability of anti-nausea drug Zensana (ondansetron oral spray) versus GlaxoSmithKline's currently approved Zofran (ondansetron) solution,

Both Zofran sprays tested demonstrated peak concentrations roughly four times greater than Zensana oral solution, the company said.

And both Zensana formulations were absorbed 45% faster then Zofran.

Results from the study were presented at the American Association for Cancer Research-National Cancer Institute-European Organization for Research and Treatment of Cancer International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia.

Hana said these results are consistent with an earlier pilot clinical trial and other models, where administering drugs through buccal and oral mucosa delivers improved systemic absorption and the potential for faster onset of action.

"We look forward to initiating pivotal clinical studies designed to explore the potential of Zensana as a new and convenient alternative formulation for treating nausea and vomiting associated with chemotherapy," said Greg Berk, Hana chief medical officer and vice president, in a company news release.

Patients experiencing nausea and vomiting have difficulty swallowing and holding down pills. Drug delivery via a spray to the oral mucosa is more convenient and avoids degradation in the gastrointestinal tract and metabolism by liver enzymes, the company said.

Hana will begin Zensana pivotal trials by the end of 2005 and plans to launch the drug in the United States in 2007.

The company licensed Zensana from NovaDel Pharmaceuticals for use in the United States and Canada.

Hana Biosciences Inc. is a South San Francisco, Calif.-based biopharmaceutical company that acquires, develops, and commercializes products to advance cancer care.


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