BioDelivery Sciences confirms dose proportionality with BEMA Fentanyl

By Elaine Rigoli

Tampa, Fla., April 24 - BioDelivery Sciences International, Inc. announced the results of a pharmacokinetic study with BEMA Fentanyl, demonstrating that both peak plasma fentanyl concentrations and overall exposure increase in a linear manner across the range of BEMA Fentanyl doses tested.

This result is known as dose proportionality, meaning that a change in the dose results in a proportional change in the maximum circulating concentration of the subject pharmaceutical. Achieving dose proportionality is a key milestone in the clinical testing of a pharmaceutical product.

This study was performed in healthy subjects to evaluate the relationship between the dose of fentanyl administered and the plasma concentrations achieved, the company said in a news release.

Plasma fentanyl concentrations are related to the pharmacologic effects of the product, and normal volunteers are typically used for these studies.

Participating subjects received each of three different doses of BEMA Fentanyl, the release said.

"The results demonstrated that mucosal absorption of fentanyl can be rapid and predictable, without the need for patient effort in the application process. We believe that this ease of administration will distinguish BEMA Fentanyl as a product for the management of breakthrough cancer pain," said Andrew Finn, executive vice president of clinical development and regulatory affairs, in the release.

The company, which plans to complete the phase 3 program by the end of 2006, said it estimates that BEMA Fentanyl will generate minimum annual peak sales of $250 million.

BioDelivery Sciences, a specialty biopharmaceutical company that seeks to develop and commercialize acute treatments for pain, anxiety, vomiting and infections, maintains headquarters in Morrisville, N.C.

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