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Scolr’s ondansetron tablets found to outperform Glaxo rival

Scolr Pharma has successfully completed pilot bioavailability testing of its amino acid technology extended release ondansetron tablets, showing they may be superior to a similar product marketed by GlaxoSmithKline.

The company said the results provide further evidence that its patented amino acid Controlled Delivery Technology (CDT) based platform may be a viable alternative to currently utilized solubility and permeability-enhancing practices.

Ondansetron hydrochloride is the active ingredient in Zofran, GlaxoSmithKline’s tablet and injection formulations to prevent chemotherapy and radiation related nausea and vomiting. Commercially available Zofran 8mg and 24 mg tablets served as the controls for Scolr Pharma’s pilot study.

The pilot study 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 8 mg Zofran tablet.

“On the basis of these positive results, we plan to optimize our raloxifene and ondansetron formulations for continued evaluation and to expand the application of our amino acid technology to two new drug targets. The new targets include developing novel formulations of fenofibrate and gabapentin. Our goal with these new formulations will be to offer tangible improvements over the current commercial products,” said Stephen Turner, Scolr’s chief technical officer.