Hana Announces Positive Pharmacokinetic Results of Ondansetron Trial
Hana Biosciences has announced positive results of a pilot pharmacokinetic clinical trial that was conducted using its proprietary lingual spray version of ondansetron HCl (the active ingredient marketed under the brand name Zofran by GlaxoSmithKline) for the treatment of chemotherapy-induced nausea and vomiting.
The study was designed to compare the pharmacokinetic profile of 8 mg of the ondansetron lingual spray to an 8-mg oral tablet of Zofran. The study achieved its goal of demonstrating the ability to deliver ondansetron via the lingual spray technology and produce a similar pharmacokinetic profile to the currently marketed oral tablet, with faster drug delivery.
The study was conducted using nine healthy male volunteers. Each volunteer was given an 8-mg Zofran tablet and the same dose of a lingual spray version at weekly intervals. Plasma ondansetron levels were measured and analyzed for standard pharmacokinetic parameters.
Hana's ondansetron lingual spray demonstrated faster drug delivery than achieved with the 8-mg oral tablet. Time to achievement of measurable drug concentrations was approximately 20 minutes shorter for the spray when compared to the oral tablet. During the first 20 minutes after dosing, the lingual spray formulation achieved statistically significant increases in the total amount of drug delivered and in the mean ondansetron concentration.
From the standpoint of safety, the mean maximum plasma concentration and bioavailability, as measured by area-under-the-curve, achieved during the entire 12-hour observation period for the 8-mg lingual spray, did not exceed that of the oral tablet. There was no evidence of safety or tolerability issues. None of the subjects discontinued the study.