BioDelivery Sciences International recently completed an FDA recommended trial as part of the New Drug Application (NDA) to examine the effects of multiple BEMA Buprenorphine/Naloxone (BNX) films administered concurrently. Results of the pharmacokinetic study were positive, indicating that the NDA is on track for submission in early 2013. BDSI expects to have key data from the study in the third quarter of 2012, and the final clinical requirement for an open label study will be initiated at this time.
The intention of the study was to examine dose proportionality ahead of the forthcoming pharmacokinetic study. The results confirmed that the buprenorphine pharmacokinetics were nearly identical following multiple BNX films applied at one time compared to an equivalent dose administered as a single film. Additionally, a linear relationship was found in buprenorphine pharmacokinetics across the dose range of BNX administered, meaning that as doses of BNX increased, there was a corresponding increase in the amount of buprenorphine in the plasma. The study also demonstrated that the exposure of naloxone is similar to the reference standard, Suboxone, which provides additional confidence that the doses selected for BDSI’s upcoming pivotal pharmacokinetic study for BNX will produce similar buprenorphine pharmacokinetics as the reference standard. This pivotal pharmacokinetic study is a critical component of the NDA.
“We are pleased to have again demonstrated the ability of our BEMA drug delivery technology to provide solid dose proportionality,” said Dr. Andrew Finn, Executive Vice President of Product Development. “The outcome of this study not only satisfies the FDA’s request for a multiple film evaluation, but it also enhances the probability of success for BNX in our upcoming pivotal pharmacokinetic study versus Suboxone.”
Nearly 2 million people in the US are dependent on prescription opioids according to the 2010 National Survey on Drug Use and Health, conducted by the U.S. Department of Health and Human Services. Suboxone was approved in 2002 and currently generates annual sales of more than $1.2 billion, growing over 20% in 2011 according to data from Wolters Kluwer, and has been shown to be a highly effective treatment option. BDSI believes that BNX, which uses BDSI’s proprietary BEMA delivery technology, has the potential to offer advantages over Suboxone and could capture significant market share.
BioDelivery Sciences International, headquartered in Raleigh, NC, is a specialty pharmaceutical company that leverages patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI focuses on developing products that meet unmet patient needs in the areas of pain management and oncology supportive care.
BDSI’s pain franchise currently consists of two products utilizing the patented BEMA technology:
• ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.).
• BEMA Buprenorphine is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioids.
For more information, visit www.bdsi.com
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