BioDelivery Sciences Announces NDA Submission for BUNAVAIL on Track Following Positive Pre-NDA Meeting with FDA

FDA“BioDelivery Sciences International, Inc. (BDSI) announced on June 10 that it engaged in a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding BUNAVAIL for the maintenance treatment of opioid dependence.

The positive outcome of the pre-NDA meeting allows BDSI to maintain its expectation of an NDA filing with FDA for BUNAVAIL in mid-summer 2013 as planned.

This scheduled meeting with FDA regarding the NDA submission of BUNAVAIL was undertaken to review the key data elements for the NDA, which includes data from a positive pivotal bioequivalence study versus Suboxone, an open-label safety study in patients switched from Suboxone film or tablets to BUNAVAIL, and product stability information.  As a result of the feedback obtained, BDSI will continue forward with its NDA submission as planned.

http://www.prnewswire.com/news-releases/biodelivery-sciences-announces-nda-submission-for-bunavail-on-track-following-positive-pre-nda-meeting-with-fda-210801051.html

Source: PR Newswire – 6/10/13

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