BioDelivery Sciences International, Inc. (BDSI - Free Report) is working hard to develop its pipeline. We believe the pipeline at BioDelivery Sciences must deliver to facilitate the company’s long-term growth. Currently, the company has only one marketed product, Onsolis, for the management of breakthrough pain in opioid tolerant, adult patients with cancer.
BioDelivery Sciences focuses on developing products for pain management and addiction using its proprietary patented drug delivery technologies. The U.S. Food and Drug Administration accepted BioDelvery Sciences’ New Drug Application (NDA) for Bunavail for the maintenance therapy of opioid dependence. A response from the U.S. regulatory body is expected by Jun 2014.
Bunavail (buprenorphine naloxone buccal film), like Onsolis, is based on the company’s patented BioErodible MucoAdhesive (BEMA) drug delivery technology. BEMA is based on application of a thin film to the inner lining of the cheek.
The NDA for Bunvail was based on the results of an open-label safety study comprising 249 opioid dependent patients who switched from Suboxone tablets or films to Bunavail. In the study, it was observed that Bunavail was easier to use and tasted better than Suboxone.
Bunavail is a combined high dose formulation of buprenorphine and naloxone. Management believes that following approval, Bunavail would be the first treatment for opioid dependence administered in a dosage form instead of other treatments which require tongue (sublingual) administration.
We note that last month BioDelivery Sciences and partner Endo Health Solutions Inc. (ENDP - Free Report) provided update on development of another candidate, BEMA Buprenorphine, based on BEMA technology. BEMA Buprenorphine is undergoing phase III studies for chronic pain management.
The companies stated that they have completed the interim analyses of two phase III studies on the candidate. While one of the studies involved opioid naive patients, the other evaluated opioid experienced patients. The interim analysis of the study on opioid naïve patients revealed that no adjustments in the sample size were necessary and the original assumptions regarding sample size were appropriate. With the interim analysis not revealing the need for additional patients, the companies expect data from the study in early 2014.
We remind investors that in Jan 2012, Endo Health inked a global license and development agreement with BioDelivery Sciences regarding BEMA Buprenorphine. Per the terms of the deal, Endo Health is responsible for manufacturing, distribution and commercialization of BEMA Buprenorphine on a worldwide basis.
BioDelivery Sciences carries a Zacks Rank #2 (Buy). Companies that currently look well-positioned include Actelion Ltd. with a Zacks Rank #1 (Strong Buy) and Alexion Pharmaceuticals, Inc. (ALXN - Free Report) with a Zacks Rank #2 (Buy).