HANA SUBMITS NDA FOR ONDANSETRON ORAL SPRAY

The FDA has accepted for review the Hana Biosciences's new drug application (NDA) for Zensana (ondansetron HCI) Oral Spray for the prevention of nausea and vomiting associated with chemotherapy and radiation.

The company completed bioequivalence and bioavailability trials of Zensana in early 2006 and submitted its application on June 30. The FDA is expected to make a decision by April 30, 2007.

Zensana is the first 5-HT3 antagonist to deliver ondansetron, a standard antiemetic therapy, in a convenient micromist oral spray. Based on clinical trial data, Hana believes Zensana is statistically bioequivalent to ondansetron tablets with faster initial delivery time. Ondansetron, a selective blocking agent of the hormone serotonin, is an FDA-approved active ingredient that is widely used in tablet form to prevent nausea and vomiting. Many chemotherapy and radiation patients requiring antiemetic therapy experience dysphagia, a discomfort or difficulty swallowing tablets, due to mouth and throat sores, inflammation or dry mouth.