BioDelivery Sciences International has filed a new drug application with the U.S. Food and Drug Administration for its proposed treatment of “breakthrough cancer pain.”
BDSI (Nasdaq: BDSI) submitted the application for BEMA Fentanyl on Wednesday.
BDSI acquired its oral drug-delivery technology called BEMA in 2004. BEMA involves a dissolvable material that is coated with the opioid narcotic fentanyl.
BDSI hopes to receive approval to begin sale of the pain reliever in 2008. It projects annual sales of $250 million in the U.S.
BDSI received a $30 million payment from European life science firm Meda AB as part of a partnership to develop BEMA Fentanyl.
In April, BDSI reported trial results that it said met the primary efficacy endpoint in a clinical trial
“Our team has been very diligent in following the FDA’s guidance on the development of BEMA Fentanyl and the preparation of the NDA,” said David Wright, director of regulatory affairs at BDSI. “Given the nature of our pre-submission communications with the FDA, we anticipate a very interactive review process over the next 10 months.”