BioDelivery Sciences Announces Confirmation of Final Formulation of BEMA Buprenorphine/Naloxone Based on Positive BNX-102 Study

BioDelivery Sciences International, Inc. BDSI announced results from its confirmatory study, BNX-102, assessing the pharmacokinetics of its BEMA Buprenorphine/Naloxone formulation compared to Suboxone. The results confirm the final formulation and provide the basis for moving forward into the pivotal comparative pharmacokinetic study versus Suboxone. BNX is being developed for the treatment of opioid dependence and contains the same drug components, both buprenorphine and naloxone, as Suboxone, the only currently marketed formulation. "The results of the BNX-102 study confirmed that the formulation and dose selection derived from our earlier BNX-101 study provide comparable exposure of both component drugs to the reference standard, Suboxone," stated Dr. Andrew Finn, Executive Vice President of Product Development. "Matching each of the pharmacokinetic standards for a combination product such as Suboxone presents particular drug delivery challenges – and as a result, despite numerous attempts, Suboxone remains without generic competition nearly two years after losing its market exclusivity. Given the significance of this opportunity and the unusual development requirements for products with an abuse deterrent component, we now want to take the prudent step of confirming our regulatory strategy with the FDA by meeting with them in the next 30 days, or at their earliest availability, prior to proceeding to our pivotal comparative pharmacokinetic study, BNX-103, immediately thereafter. We expect this conservative approach creates the potential to significantly reduce any potential regulatory risk for BNX and is consistent with our previously stated strategy."