BioDelivery Services International (NASDAQ:BDSI) has filed for Food and Drug Administration approval for Bunavail, a product that would mark the company’s entry into the opioid dependence treatment market.
Bunavail delivers buprenorphine and naloxone, a combination of drug abuse treatment drugs, through a small piece of film that dissolves after being placed on the inside of the cheek. In the United States, nearly 2 million American are dependent on prescription opioids, according to a 2010 National Survey on Drug Use and Health conducted by the U.S. Department of Health and Human Services. This market is currently dominated by Suboxone, a product that generates more than $1.5 billion in annual sales for Reckitt Benckiser, according to Wolters Kluwer data.
Suboxone, approved in 2002, also delivers the buprenorphine and naloxone combination. But Suboxone is placed under the tongue. With Bunavail, BDSI aims to secure FDA-approval on the first product that delivers the drug combination through the inside lining of the cheek. BDSI’s “BioErodible MucoAdhesive” or BEMA technology was at the center of the company’s first FDA-approved product, Onsolis. Onsolis uses the proprietary drug-delivery technology to administer the pain-killer fentanyl to cancer patients experiencing breakthrough cancer pain.
In addition to speedy delivery of buprenorphine, which is poorly absorbed through the gastrointestinal tract, BDSI has said that the BEMA technology employed by Bunavail will overcome the unpleasant taste that is a chief complaint of some Suboxone users. In clinical trials, BDSI tested Bunavail to be bioequivalent to Suboxone. The company also tested the safety and tolerability of Bunavail in patients who switched to Bunavail from Suboxone film or tablets.
BDSI last month secured a $20 million loan that the company said would support its drug pipeline, including Bunavail. Raleigh-based BDSI expects to receive an FDA decision on Bunavail in about 10 months.
