BDSI® believes that the BEMA drug delivery system has the potential to deliver a wide range of drugs and continues to explore additional opportunities for future development and commercialization.
BEMA Buprenorphine/Naloxone
BioDelivery Sciences is developing BEMA Buprenorphine/Naloxone for the treatment of opioid dependence. The product will combine a "high dose" of buprenorphine along with an abuse deterrent agent, naloxone. Preliminary pharmacokinetic studies have demonstrated the ability of the BEMA technology to deliver the high doses of buprenorphine necessary for the treatment of opioid dependence.
A BEMA Buprenorphine/Naloxone product would provide BDSI with an opportunity to compete in a rapidly growing opioid dependence market. Buprenorphine is widely used in the treatment of opioid dependence and is marketed as Suboxone® (buprenorphine/naloxone) and Subutex® (buprenorphine). Accordingly to Wolters Kluwer, U.S. sales of buprenorphine containing products for the treatment of opioid dependence exceeded $1 billion in 2010. Initial pharmacokinetic studies have demonstrated the ability of the BEMA technology to deliver doses of buprenorphine needed for the treatment of opioid dependence.
BEMA Granisetron
BioDelivery Sciences is developing BEMA Granisetron for the prevention of nausea and vomiting associated with cancer therapies.
This product candidate utilizes the BEMA technology to deliver the 5-HT3 receptor antagonist granisetron (marketed as Kytril®), an FDA approved antiemetic indicated for the prevention of nausea and vomiting following cancer chemotherapy and radiation. According to retail sales data from Wolters Kluwer, the U.S. market for 5-HT3 antagonists is significant and exceeds $1.7 billion. We filed an Investigational New Drug (IND) application for BEMA Granisetron in early 2011. We believe that in the presence of nausea and vomiting, BEMA Granisetron would have the potential for better tolerance than oral formulations, as well as potential for better and more consistent absorption.
Suboxone® and Subutex® are registered trademarks of Reckitt Benckiser Healthcare Ltd.
Kytril® is a registered trademark of Genentech USA , Inc.