BioDelivery Sciences International (NASDAQ:BDSI) remains on track to file a new drug application in midsummer for Bunavail, the company’s maintenance treatment for opioid dependence.
The Raleigh company announced the progress following what BDSI described as “a positive” meeting with the Food and Drug Administration regarding the company’s currently experimental treatment.
Bunavail uses BDSI’s drug delivery technology to administer the buprenorphine, a drug used for opioid dependence. BDSI’s patented technology delivers a drug via a soluble film that is placed on the inside of the cheek. BDSI aims to challenge market leader Reckitt Benckiser, whose Suboxone administers buprenorphine via a small piece of disssolvable film placed under the tongue.
More than 2 million people in the United States suffer from opioid dependence. RB claims that Suboxone has given it 64 percent of the market to treat such patients. Suboxone generated nearly $1.5 billion in 2012 revenue, according to data compiled by drugs.com. BDSI has said among Bunavail’s advantages is offering treatment without the unpleasant taste that is a complaint of some patients treated with Suboxone. BDSI believes it can pick up as much as $250 million in sales from this market.