Based on positive results of a pharmacokinetic study, BioDelivery Sciences International ($BDSI) is planning a second-quarter 2013 submission for marketing approval of its BioErodible MucoAdhesive (BEMA) formulation of buprenorphine and naloxone for the treatment of opioid dependence. According to the Department of Health and Human Services, almost 2 million people are dependent on prescription opioids in the U.S., creating a market worth more than $1.2 billion and growing.
BEMA is a small piece of bioerodible polymer film that fixes to the inside of the cheek and delivers drug across the mucous membrane as it erodes. The study compared the bioavailability of buprenorphine and naloxone in the BEMA formulation and in Suboxone, the reference product. The pharmacokinetics parameters of buprenorphine were comparable to Suboxone, and the same parameters were similar or less than Suboxone for nalaxone, as in the goals agreed with the FDA. The BEMA formulation would be the first product to compete directly with Suboxone, according to the company.
"The results of this study allow us to not only move a step closer to the potential filing of an NDA for BNX in 2013, but also advance our commercialization considerations that include furthering our active partnership discussions for BNX," said Dr. Mark A. Sirgo, president and CEO.
BioDiscovery Sciences had a setback over its BEMA pain product BEMA Buprenorphine with some poor results against placebo in a Phase III study, but Endo Pharmaceuticals ($ENDP) was confident enough over the other results to sign a $180 million deal for the product. BEMA Buprenorphine is also undergoing a 12-week safety study, which the Triangle Business Journal estimates will cost $5 million to $6 million. The cost of the study and the submission to the FDA will be funded by the deal with Endo.
- read the press release
- see the article in the Triangle Business Journal
Special Report: BioDelivery Sciences and Endo Pharmaceuticals -- Top 20 biotech licensing deals in H1 2012