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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.

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