BioDelivery Sciences International announced Wednesday that federal regulators expect to complete their review of the Raleigh company's new drug application for its treatment for opioid dependence by June 2014.
The U.S. Food and Drug Administration has informed BioDelivery Sciences that it has accepted the new drug filing it made in August for Bunavail, indicating that the agency considers the application to be complete enough to permit a review.
Opioid dependence affects more than 2 million people in the United States. Opioids are painkillers including morphine, methadone and oxycodone.
Bunavail is being developed as a competitor to Suboxone, which generated more than $1 billion in sales last year.
BioDelivery Sciences believes Bunavail has the potential to general annual sales of up to $250 million.