The study is designed to assess the efficacy and safety of BEMA Buprenorphine which is used to treat moderate to severe chronic pain.
BDSI Product Development executive vice president Andrew Finn said over the next several weeks, they will be completing the administrative activities that will lead to a database lock followed by statistical analysis and the availability of results.
The top line clinical results are expected in September this year.
"Assuming positive study results, we would hope to be in a position to file a New Drug Application (NDA) for this product in the first half of 2012," Finn said.