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www.fdanews.com/articles/68555-bdsi-completes-clinical-trials-for-its-formulation-of-emezine

BDSI Completes Clinical Trials for its Formulation of Emezine

February 9, 2005

BioDelivery Sciences International (BDSI) has completed the clinical studies required for its pending new drug application on Emezine, a buccal product for the treatment of nausea and vomiting.

Emezine will be the first product in the U.S. market for the treatment of nausea and vomiting to be provided via a buccal (across the cheek membrane) delivery system. BDSI, through its Arius Pharmaceuticals subsidiary, licenses Emezine from a third-party pharmaceutical company.

BDSI's Emezine product is administered by placing a tablet between the gum and the cheek where it dissolves, enabling the active ingredient to be absorbed through the lining of the cheek. This formulation provides for a rapid onset of action and an alternative to swallowed tablets, suppositories or injections. BDSI believes that delivering an antinausea drug transbuccally may offer advantages over traditional delivery methods.