Hana starts trials of Zensana for chemotherapy-induced nausea and vomiting

New York, Dec. 12 - Hana Biosciences said the Food and Drug Administration has cleared its Investigational New Drug Application for Zensana and the company started Monday a series of pivotal pharmacokinetic trials, including comparison of Zensana to the commercially available ondansetron tablet (GlaxoSmithkline's Zofran).

Hana added that it expects to complete these pivotal trials by early 2006 and plans to file the New Drug Application thereafter. Commercial launch of Zensana is targeted for 2007.

"Because it will help chemotherapy patients get on with their lives, Zensana has a promising market potential as a new and convenient alternative formulation for treating nausea and vomiting associated with chemotherapy," said Mark J. Ahn, president and chief executive officer of Hana Biosciences, in a news release. "We plan to develop the proprietary product rapidly so it will be available to help the thousands of patients who seek fast relief from chemo-induced nausea and vomiting."

Hana said it intends to file a New Drug Application under section 505(b)(2), a form of registration that relies on data in previously approved New Drug Applications and published literature.

Zensana (ondansetron oral spray) is the first multidose oral spray 5-HT3 antagonist, according to the South San Francisco, Calif., biopharmaceutical company.

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

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