BioDelivery Sciences International says its proposed alternative treatment for opioid-dependent patients is safe and also is safely tolerated when users of another product are switched.
BDSI (NYSE: BDSI) said the results of its study will help it prepare to file a New Drug Application with the U.S. Food and Drug Administration later this year.
The treatment is called BEMA Buprenorphine/Naloxone. BEMA refers to the technology through which the drug is administered.
“Results demonstrate that BNX is easy to use and well tolerated. Importantly, the study also demonstrated that physicians could switch their opioid dependent patients from Suboxone to BNX without difficulty,” said Dr. Andrew Finn, BDSI’s executive vice president for product development.
The study included 249 patients who were switched from the current market product called Suboxone, which BDSI says generated $1.5 billion in sales in 2012.