Positive results for SCOLR's ondansetron CR

US drugmaker SCOLR Pharma says that it has successfully completed pilot bioavailability testing in Canada of its Controlled-Delivery Technology extended-release ondansetron tablets. This is the second application of its amino acid technology. The firm says that the testing results provide further evidence that SCOLR's patented amino acid CDT-based platform may be a viable alternative to currently utilized solubility and permeability-enhancing practices.

Ondansetron HCl is the active ingredient in Zofran, GlaxoSmithKline's tablet and injection formulations to prevent chemotherapy and radiation-related nausea and vomiting. In 2005, GSK reported over $1.5 billion in global Zofran sales. Commercially available Zofran 8mg and 24mg tablets served as the controls for SCOLR's pilot study.

The company's ondansetron pilot testing consisted of a 30-subject, randomized, five-way cross-over and open-label fasting design. It compared three prototype extended-release 24mg. CDT amino acid-based ondansetron tablet formulations to 8mg and 24mg immediate-release Zofran tablets. The results indicate the CDT-based non-optimized tablet formulations may provide higher initial blood levels and extended drug release as compared to the 8mg Zofran tablet.