BioDelivery Sciences to conduct additional Emezine studies

By Elaine Rigoli

Tampa, Fla., June 9 - BioDelivery Sciences International, Inc. said that it will be conducting two small pharmacokinetic studies, following a recent meeting with the Food and Drug Administration to determine what additional studies would be needed to proceed with Emezine (prochlorperazine maleate) buccal tablets for the treatment of nausea and vomiting.

In doing so, the company said it can avoid the necessity of having to conduct a major efficacy and safety trial in patients but still manage to answer the FDA's remaining questions.

BioDelivery said recent study results of Emezine suggest significantly greater absorption over the oral swallow tablet but considerably less absorption compared to the intravenous formulation.

The company said these were both anticipated outcomes.

These studies also demonstrated that Emezine had a slightly slower absorption pattern over the first one to two hours compared to the oral swallow tablet, according to a news release.

Further, Emezine demonstrated a higher peak plasma concentration (maximum achieved concentration of drug in the blood) compared to the 5 mg oral swallow tablet although well below that seen with the intravenous injection.

The FDA indicated that this higher peak concentration compared to the oral swallow tablet could potentially lead to a more pronounced effect in older patients and therefore requested that BioDelivery Sciences consider collecting additional information in this population.

BioDelivery Sciences is a specialty biopharmaceutical company with headquarters in Morrisville, N.C.

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