Raleigh drug developer BioDelivery Sciences International said Monday it expects to file for the federal approval of its next drug this summer.
The company, which developers alternate drug delivery methods, said it had a positive meeting on its new drug with the U.S. Food & Drug Administration, the agency that approves and regulates medications. Such meetings are the gateway to beginning a formal application process.
BioDelivery said its new drug, Bunavail, is designed for the treatment of opioid dependence, which affects more than 2 million people in the United States.
Bunavail is being developed as a competitor to Suboxone, which generated more than $1 billion in sales last year. Both Suboxone and Bunavail are administered by film application.
Opioids are potent, addictive painkillers; they include morphine, methadone and oxycodone.
BioDelivery has one drug on the market, a pain patch for cancer patients, and several under development.
The company's stock closed at $4.38, up 5 cents. It has gained 29 percent in the past year.