Based on successful results of this pilot pharmacokinetic trial in healthy volunteers, Hana intends to file an investigational new drug (IND) application to commence an abbreviated clinical development program. If the results are successful, Hana expects the oral spray version to be available in 2007. The patent for Zofran expires in June, 2006.
Ondansetron belongs to a class of drugs known as 5HT3 antagonists that are widely used to prevent chemotherapy-induced nausea and vomiting. According to the National Cancer Institute, over 500,000 Americans received chemotherapy in 2004, and the majority of these patients received an anti-emetic such as ondansetron to prevent nausea and vomiting.
Hana acquired the rights to market the novel lingual spray formulation in the US and Canada from NovaDel Pharma in 2004. The new formulation utilizes NovaDel’s patented lingual spray drug delivery technology, which is designed to enhance convenience with a multidose formulation and to achieve more rapid onset of therapeutic activity though buccal absorption. For chemotherapy patients seeking quicker relief of nausea and vomiting, this is considered a desired benefit.
“The convenience of a mouth spray to rapidly and effectively prevent chemotherapy-induced nausea and vomiting is a welcome addition to our anti-emetic choices, as oral ingestion of pills can be difficult in this setting,” said Dr Greg Berk, chief medical officer and vice president of Hana Biosciences.
Once the pharmacokinetic profile is established, Hana plans to evaluate ondansetron lingual spray in several oncology settings, including adjuvant breast cancer, radiation therapy, and pediatrics.