Hana Biosciences Withdraws NDA for Zensana, Halts Development

Hana Biosciences announced it has decided to stop development of its current Zensana formulation and withdraw the new drug application (NDA) it submitted to the FDA in June 2006, without prejudice.

The company previously announced that long-term stability studies had detected small amounts of precipitated material in scale-up batches of Zensana (ondansetron HCI), which it said might delay FDA approval of the drug. Hana's partner and licensor, NovaDel Pharma, has developed an alternate formulation of the product, and Hana plans to work with NovaDel to evaluate the new formulation.

Hana was developing Zensana as an oral spray for the prevention of nausea and vomiting as a result of chemotherapy, radiation and surgery. 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, according to the company. Hana believes that the oral spray may be an attractive alternative to tablets and other forms of ondansetron.