BioDelivery Sciences International, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Bunavail (buprenorphine and naloxone buccal film) for the maintenance therapy of opioid dependence.
Bunavail is based on BioDelivery Sciences’ patented BioErodible MucoAdhesive (BEMA) drug delivery technology, which facilitates improved absorption of buprenorphine and helps in overcoming some of the administration challenges involved in the sublingual (under the tongue) form of dosage currently available in the market. Bunavail’s bioavailability (drug absorbed into the body) of buprenorphine is twice compared to Suboxone, which is the market leader in this category. With this approval, Bunavail has become the first and only buprenorphine and naloxone buccal film formulation (to be applied as a thin film on the inner lining of the cheek) to be approved by the FDA. Bunavail is to be used as part of a complete treatment package including counseling and psychosocial support.
BioDelivery Sciences intends to launch Bunavail towards the end of the third quarter of 2014. BioDelivery is focusing totally on the commercialization of the drug and will use a dedicated sales force for the launch. The company inked an agreement with Quintiles in Mar 2014 for supporting the launch of the drug. In addition, BioDelivery Sciences’ agreement with Ashfield Market Access will maximize patient access to Bunavail by providing managed markets and trade support. The company will announce additional information regarding the commercialization of Bunavail shortly. Deals in ex-U.S. markets should also be signed in the near future.
The opioid dependence market in the U.S., which is worth more than $1.7 billion, according to BioDelivery Sciences, represents significant commercial potential. The approval of Bunavail further strengthens the company’s pain portfolio. Bunavail will compete with Suboxone sublingual film in the market for opioid dependence. In 2013, U.S. sales of Suboxone sublingual film were more than $1.3 billion. The company expects Bunavail peak sales in the U.S. to be up to $250 million.