Drug company BioDelivery Sciences International said it is remains on track to seek marketing approval of its experimental treatment for patients who are dependent on pain medications later this year.
The Raleigh company reported Tuesday that it has completed the safety and tolerability study of its experimental drug BNX and, according to preliminary data, found no unexpected adverse side effects.
"It was the last study we need to complete before we can submit the (new drug application)," said CEO Mark Sirgo. The company expects to submit its application in mid-2013.
BNX is a formulation of the brand-name drug Suboxone that is administered through a film applied to the inner lining of the cheek, which enables using less drug to achieve the same benefits, Sirgo said.
"We think it is a better way to deliver a very good drug," he said.
Analyst Tim Lugo of William Blair & Co. estimates that BNX could achieve peak annual sales of $240 million. He anticipates the Food and Drug Administration will approve the drug this year.
BioDelivery Sciences was trading at $4.24, up 2 cents, early Tuesday afternoon. The stock hit its 52-week high of $6.78 in October.