June 28, 2012
/PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced positive results of a recently completed pharmacokinetic study (BNX-106) examining the effects of multiple BEMA Buprenorphine/Naloxone (BNX) films administered concurrently. This study was part of the U.S. Food and Drug Administration (FDA) recommended program for a New Drug Application (NDA) for BNX.
The study confirmed that the buprenorphine pharmacokinetics were nearly identical following multiple BNX films applied at one time compared to an equivalent dose administered as a single film. Additionally, there was a linear relationship in buprenorphine pharmacokinetics across the dose range of BNX administered, meaning that as doses of BNX increased, there was a corresponding increase in the amount of buprenorphine in the plasma. Regarding the naloxone component of BNX, the study demonstrated that the exposure of naloxone is similar to the reference standard, Suboxone.
Overall, these results provide additional confidence that the doses selected for BDSI's upcoming pivotal pharmacokinetic study for BNX will produce similar buprenorphine pharmacokinetics as the reference product, Suboxone. This pivotal pharmacokinetic study is a critical component of the NDA.
"We are pleased to have again demonstrated the ability of our BEMA drug delivery technology to provide solid dose proportionality," said Dr.
, Executive Vice President of Product Development. "The outcome of this study not only satisfies the FDA's request for a multiple film evaluation, but it also enhances the probability of success for BNX in our upcoming pivotal pharmacokinetic study versus Suboxone."
BDSI expects to have key data results from the pivotal pharmacokinetic study versus Suboxone in late third quarter of this year after a mid-summer initiation. The final clinical requirement for the NDA, an open-label safety study, will initiate on time in the third quarter allowing BDSI to remain on track for an NDA filing in the first half of 2013.