“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.
Source: PR Newswire – 6/10/13