BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today that enrollment of its Phase 3 trial assessing the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain is on schedule, with over half of the needed subjects enrolled.
"We are very pleased with the enrollment to date for this pivotal Phase 3 study for our next product BEMA Buprenorphine," stated Dr. Andrew Finn, Executive Vice President of Product Development at BDSI. "We are on schedule with enrollment as a result of a very focused effort both internally and with the enthusiastic support of an outstanding group of experienced investigators. Based on current progress, we feel comfortable that we will meet our goal of reporting top-line results in the third quarter of this year. Positive findings from this study would then allow for an anticipated NDA filing early in the second quarter of 2012."
BDSI believes that there remains a significant unmet medical need for potent new analgesics for the treatment of chronic pain. Buprenorphine is an attractive option for development because of its potent analgesic properties, its differentiating characteristics from other opioids, and its DEA Schedule III designation, which means there is less addiction potential than Schedule II products. According to Wolters Kluwer, opioid analgesic sales in the U.S. are in excess of $10 billion and growing, and BDSI believes that BEMA Buprenorphine has the potential to exceed $500 million in peak annual sales.
It's official! Men and women experience and manage pain differently