Spray antiemetic shows postive effect

A pilot pharmacokinetic clinical trial that was conducted using Hana Biosciences proprietary lingual spray version of ondansetron hydrochloride (the active ingredient marketed under the brand name Zofran by GlaxoSmithKline) for the treatment of chemotherapy-induced nausea and vomiting has produced positive results.

The study was designed to evaluate the pharmacokinetic profile of 8mg of the ondansetron lingual spray to 8mg oral tablet of Zofran. The study achieved its goal of demonstrating the ability to deliver ondansetron via a lingual spray technology and produce a similar pharmacokinetic profile to the currently marketed oral tablet, with a faster drug delivery.

'We are extremely encouraged by the positive results from this initial study. We look forward to moving ondansetron lingual spray into pivotal trials this year,' said Dr Mark Ahn, president and ceo, Hana Biosciences. 'Assuming successful results, Hana expects the oral spray version to be available in 2007.'

The study was conducted using 9 healthy male volunteers. Each volunteer was given an 8mg Zofran tablet and the lingual spray ondansetron at weekly intervals. Plasma ondansetron levels were measured and analysed for standard pharmacokinetic parameters.

Hana's ondansetron lingual spray demonstrated faster drug delivery than achieved with the 8mg oral tablet. Time to measurable drug concentration was approximately 20 minutes shorter for the spray when compared with the oral tablet. During the first 30 minutes post-dosing, lingual spray formulation achieved approximately four-fold increase in the total amount of drug and mean ondansetron concentration. Noted treatment differences were statistically significant. Importantly from the standpoint of safety, the mean maximum plasma concentration (Cmax) and bioavailability, as measured by area-under-the-curve (AUC), achieved during the entire 12-hour observation period for the 8mg lingual spray did not exceed that of the oral tablet. There was no evidence of substantial safety or tolerability issues. None of the subjects discontinued the study.

'Based on successful results of this pilot bioequivalence trial in healthy volunteers, we intend to file an Investigational New Drug (IND) Application to commence an abbreviated clinical development program designed to support a 505(b)(2) submission, a form of New Drug Application (NDA) that relies on data in previously approved NDAs and published literature', said Dr Greg Berk, chief medical officer and vice president, Hana Biosciences. 'We also plan to study ondansetron lingual spray in the breast cancer setting, as well as pediatrics and radiation therapy.'

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 antiemetic such as ondansetron to prevent nausea and vomiting. Annual US sales for Zofran, the world's leading antiemetic, were approximately $1bn in 2003, and the product patent expires in June 2006.

Hana acquired the rights to market the novel lingual spray formulation in the US and Canada from NovaDel Pharma in 2004. The new formulation utilises NovaDel's patented lingual spray drug delivery technology. This is designed to enhance convenience with a multidose formulation and to achieve more rapid onset of therapeutic activity though buccal (oral tissue) absorption. For chemotherapy patients seeking quicker relief of nausea and vomiting, this is considered a desired benefit. NovaDel was awarded a patent directed to a lingual spray version of ondansetron in 2004.