BioDelivery Sciences International, Inc. announced the completion of enrolment in its phase III clinical trial assessing the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain.
“The completion of enrollment in our phase III efficacy study marks another very important milestone in our clinical development programme for BEMA Buprenorphine in the management of chronic pain,” stated Dr Andrew Finn, executive vice president of Product Development at BDSI. “We are very pleased to have achieved our aggressive recruitment and enrollment goals. This milestone keeps us on target for reporting top-line study results in the third quarter of this year and is consistent with a timeline that would allow for a New Drug Application (NDA) to be filed 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. The company believes that 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.
In addition, BEMA Buprenorphine has the potential to be the first oral transmucosal form of buprenorphine to treat chronic pain in the US. According to Wolters Kluwer, opioid analgesic sales in the US 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.
The phase III trial of BEMA Buprenorphine (referred to as BUP-301) is an “enriched” enrollment, double-blind, placebo-controlled, randomized withdrawal study measuring the efficacy and safety of BEMA Buprenorphine in patients with moderate to severe chronic pain. Patients meeting the designated study criteria undergo titration with BEMA Buprenorphine to a dose that is both effective and well-tolerated. Those patients who identify an effective and well tolerated dose are then randomized to either continue their BEMA Buprenorphine dose or begin use of a placebo (BEMA film with no active drug) for twelve weeks.
The primary efficacy measure is the mean change in pain intensity from the time patients are randomized (to BEMA Buprenorphine or placebo) through to the end of the twelve week study period. The study design described has been utilized for a number of the opioid analgesics approved by the FDA in recent years. It includes an interim analysis to confirm the number of patients needed for adequate statistical power. This interim analysis is part of the study design agreed upon with FDA and is included solely to provide assurance that the sample size is adequate to detect the effect difference between the active and placebo treatments.
BioDelivery Sciences International is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care.