NovaDel partner files NDA for the Zensana (ondansetron HCl) Oral Spray for nausea, vomiting

By Lisa Kerner

Charlotte, N.C., July 5 - NovaDel Pharma Inc. said its partner, Hana Biosciences, submitted a New Drug Application to the Food and Drug Administration for Zensana (Ondansetron HCl) Oral Spray to prevent chemotherapy, radiation and post-operatively induced nausea and vomiting.

Acceptance of the filing by the FDA will trigger a milestone payment from Hana to NovaDel.

An additional milestone payment is due to NovaDel upon product approval. The company will also receive royalties on the product sales.

"The submission of the Zensana NDA is a key regulatory milestone for NovaDel as it moves the product closer to potential approval and commercialization," president and chief executive officer Jan Egberts said in a company news release.

If approved by the FDA, Hana targets commercial launch of Zensana in the United States in the first half of 2007.

Ondansetron is a selective blocking agent of the hormone serotonin commonly used in tablet form to prevent chemotherapy- and radiation-induced and post-operative nausea and vomiting.

The oral spray formulation meets the needs of patients receiving chemotherapy and radiation therapy experiencing difficulty swallowing.

Located in Flemington, N.J., NovaDel is an emerging specialty pharmaceutical company that is developing and commercializing oral spray therapeutics.

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