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news.Hana Bioscience is to initiate a series of pivotal trials of Zensana, an oral spray for the treatment of chemotherapy induced nausea and vomiting, after the FDA approved the company's investigational new drug application.
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The trials will include a comparison of Hana’s nasal spray with GlaxoSmithKline’s Zofran which delivers the same active ingredient in the form of a tablet. A nasal spray may be easier for patients to administer than a tablet as patients experiencing nausea and vomiting have difficulty swallowing and holding down pills.
Drug delivery via a spray to the oral mucosa also avoids degradation in the gastrointestinal tract and metabolism by liver enzymes.
Hana expects to complete these pivotal trials by early 2006 and plans to file for final approval shortly thereafter. Commercial launch of Zensana is targeted for 2007 the company said.
“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 Dr Mark Ahn, president and CEO, Hana Biosciences. “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.”