Aug. 1, 2013
/PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that yesterday it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for BUNAVAIL (buprenorphine naloxone buccal film) for the maintenance treatment of opioid dependence. Under the 505(b)(2) regulatory statute, BUNAVAIL will be subject to a ten month review.
BUNAVAIL uses BDSI's patented BioErodible MucoAdhesive (BEMA) drug delivery technology to deliver buprenorphine across the buccal mucosa (inside lining of the cheek). BUNAVAIL is formulated with the abuse deterrent agent naloxone and is designed to efficiently and conveniently deliver buprenorphine while potentially overcoming some of the challenges with other dosage forms.
"The submission of the NDA for BUNAVAIL marks another major milestone for BDSI as we seek FDA approval of a second product using our BEMA technology," said Dr.
Mark A. Sirgo
, President and Chief Executive Officer. "Opioid dependence is a serious and growing healthcare problem in this country affecting over 2 million people in the U.S. There remains a need for better dosage forms for the delivery of buprenorphine to these patients, an opportunity for which BDSI hopes to capitalize. It is our intention to bring to market a product that we believe positions us to significantly participate in this
and growing market."
Dr. Sirgo continued, "With our NDA filed we will continue to evaluate our strategic options for the commercialization of BUNAVAIL in the U.S., which include partnership, internal approaches or a combination of these. We will provide updates on our strategic direction as the year progresses."
The clinical program for BUNAVAIL, as agreed upon with FDA, included a bioequivalence study to Suboxone tablets and a study assessing the safety and tolerability of BUNAVAIL in opioid dependent subjects switched from Suboxone film or tablets to BUNAVAIL.