BioDelivery Sciences to file NDA for BEMA Fentanyl next year

By Elaine Rigoli

Tampa, Fla., Sept. 20 - BioDelivery Sciences International, Inc. said it will submit a New Drug Application on the company's phase 3 BEMA Fentanyl product during the second quarter of 2007.

The company met with officials of the Food and Drug Administration last week at the request of the company in advance of an anticipated "pre-NDA" meeting expected early next year. The purpose of the meeting was to solicit guidance on key matters regarding the NDA program for BEMA Fentanyl.

The Morrisville, N.C.-based pharmaceutical company's projection is contingent on the conclusion of the phase 3 program for BEMA Fentanyl. Current enrollment in the pivotal phase 3 efficacy trial for BEMA Fentanyl is anticipated to be completed by the end of 2006.

A separate safety trial that makes up the other component of the BEMA Fentanyl phase 3 clinical program is expected to be completed during the first half of 2007.

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