Hana Biosciences' ondansetron oral spray equivalent to tablet formulation, study says

By Angela McDaniels

Seattle, Jan. 9 - Hana Biosciences said the results from a pivotal clinical study demonstrate that Zensana (ondansetron oral spray) is statistically equivalent to GlaxoSmithKline's commercially available Zofran (ondansetron tablet).

"Zensana holds great promise as a new and convenient alternative formulation for treating patients suffering from nausea and vomiting associated with chemotherapy," Hana chief medical officer Greg Berk said in a company news release.

In addition to meeting the primary endpoints for bioequivalence, the randomized, 32-patient study found that the safety profile of Zensana was similar to Zofran.

Hana said it expects to complete additional pharmacokinetic studies by the end of the first quarter of 2006, including a multiple-dose study and a food and water effect study.

The company then plans to file a New Drug Application in the second quarter of 2006 and, pending approval, launch Zensana in 2007.

Zensana is an oral spray formulation of ondansetron, which is approved to prevent nausea and vomiting related to chemotherapy, radiation and post-operative recovery.

Hana Biosciences is a biopharmaceutical company based in South San Francisco, Calif., that acquires, develops and commercializes cancer products.

Hana acquired the exclusive rights to market Zensana in the United States and Canada from NovaDel Pharma Inc., a specialty pharmaceutical company based in Flemington, N.J., that is developing a novel, oral drug-delivery system.

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