You are here

Opioid-Dependence Drug Bunavail (Buprenorphine/Naloxone Buccal Film) Submitted for FDA Review

Combo product absorbed through cheek or under tongue (August 1)

A New Drug Application (NDA) has been submitted to the FDA for Bunavail (buprenorphine/naloxone buccal film, BioDelivery Sciences International) for the maintenance treatment of opioid dependence. The product will be subject to a 10-month review.

Bunavail delivers buprenorphine across the buccal mucosa. It is formulated with the abuse-deterrent agent naloxone.

Buprenorphine is poorly absorbed from the gastrointestinal tract when administered orally; however, it is absorbed within the oral cavity transmucosally (across the cheek or under the tongue). The drug reduces the craving and withdrawal effects induced by the dependency-causing opioid.

According to the 2010 National Survey on Drug Use and Health, nearly 2 million Americans are dependent on prescription opioids.

Source: BioDelivery Sciences International; August 1, 2013.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs