BioDelivery Sciences International submits BUNAVAIL NDA to FDA

Published on June 10, 2013 at 8:50 AM · No Comments

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today 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.  

"We are pleased with the outcome of our pre-NDA meeting where we reviewed the key elements of our NDA with the Agency," said Dr. Andrew Finn, Executive Vice President of Product Development for BDSI.  "This outcome is allowing us to move confidently forward in finalizing and submitting our NDA."

BUNAVAIL utilizes BDSI's proprietary BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine for the maintenance treatment of opioid dependence, along with the opioid antagonist naloxone, which is intended to serve as an abuse deterrent.  BDSI believes BUNAVAIL may offer meaningful advantages over existing treatments and could provide an alternative to the over 2 million people in the U.S. with opioid dependence.  Currently, Suboxone is the only available film formulation of buprenorphine and naloxone, with the film formulation generating in excess of one billion dollars in sales in 2012.  BUNAVAIL is positioned to be the next film formulation to enter the market.  BDSI believes BUNAVAIL has the potential to generate peak sales in excess of $250 million.

Source:

BioDelivery Sciences International, Inc.

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