In an update on its research, California, USA-based Hana Biosciences said that positive pivotal studies confirm its Zensana (ondansetron oral spray) 8mg dose is statistically bioequivalent to the current commercially available 8mg ondansetron (GlaxoSmithKline's Zofran) tablet, and it delivers detectable ondansetron levels statistically faster than oral Zofran.
Completion of four registrational clinical studies, ZOOS I-IV (Zensana Ondansetron Oral Spray), allows for a New Drug Application submission under section 505(b)(2) in 2006, the firm said, adding that it targets the drug for US commercial launch in 2007.
"Zensana has promising market potential as a new, convenient alternative formulation for treating nausea and vomiting associated with chemotherapy which will help patients get on with their lives," stated Mark Ahn, chief executive of the firm. "Our team is excited about establishing a focused and scalable commercial presence to serve oncologists which leverages the team's development and marketing experience," he added.
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