RALEIGH, NC – Drug developer BioDelivery Sciences said Monday it is on track to file a New Drug Application (NDA) on a drug that it expects to have peak sales of $250 million.
Before a drug hits the market, companies must file for approval with the U.S. Food and Drug Administration. BioDelivery (Nasdaq: BDSI), said it had a “positive pre-New Drug Application (NDA) meeting,” and is on track to file the application this summer.
“This outcome is allowing us to move confidently forward in finalizing and submitting our NDA,” said Dr. Andrew Finn, executive vice president of product development for BDSI, in a news release.
The drug is called Bunavail and would treat opioid dependence. BioDelivery says its product could “offer meaningful advantages” over existing treatments, which could allow it to tap into the market of 2 million people in the United States with opioid dependence.