BioDelivery Sciences International, Inc. (BDSI’s) announced on July 31 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 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.
“We are very pleased to have submitted our NDA for BUNAVAIL,” said Dr. Andrew Finn, Executive Vice President of Product Development. “If approved, BUNAVAIL will be the first dosage form for the treatment of opioid dependence that does not require under the tongue (or sublingual) administration. Utilizing the BEMA drug delivery technology, BUNAVAIL films adhere to the inside of the cheek and dissolve quickly. By keeping BUNAVAIL in contact with the mucosal surface, our data demonstrates that buprenorphine absorption is optimized and provides comparable plasma concentrations of buprenorphine to Suboxone with considerably lower doses.”
Dr. Finn concluded, “In a clinical study we conducted in which 249 opioid dependent subjects switched from Suboxone tablets or films to BUNAVAIL, the majority of patients found BUNAVAIL to be easy to use and pleasant tasting – two important attributes that may represent improvements over current therapies in patients being treated for opioid dependence.”
Source: – MarketWatch.com – August 1, 2013