BioDelivery Sciences is developing BEMA Buprenorphine for the management of moderate to severe chronic pain.
Buprenorphine is a partial agonist of the mu-opioid receptor. It is a potent analgesic with a relatively long duration of action. Buprenorphine is a Schedule III controlled substance meaning that it has lower abuse potential than Schedule II drugs.
In December 2009, we announced that the primary efficacy endpoint was achieved in a Phase 2 clinical study evaluating the safety and efficacy of a range of doses of BEMA Buprenorphine. BEMA Buprenorphine is currently in Phase 3 clinical development and results are anticipated in the third quarter of 2011. Should results be positive as anticipated, a New Drug Application (NDA) could be filed in the first half of 2012.
With opioid analgesic sales exceeding $10 billion in 2010, we believe that BEMA Buprenorphine has the potential to generate in excess of $500 million in annual sales.