The US Food and Drug Administration (FDA) has accepted BioDelivery Sciences International's (BDSI) New Drug Application (NDA), Bunavail (buprenorphine naloxone buccal film) for the maintenance treatment of opioid dependence. This indicated that the application is sufficiently complete to permit a substantive review.

Based on timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the Bunavail NDA is expected to be completed by early June 2014.

Bunavail utilizes BDSI's proprietary BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine for the maintenance treatment of opioid dependence, along with the opioid antagonist naloxone, which is intended to serve as an abuse deterrent.  Bunavail was designed to efficiently and conveniently deliver buprenorphine while potentially overcoming some of the challenges with other dosage forms.

BDSI believes Bunavail may offer meaningful advantages over existing treatments and could provide an alternative to the over two million people estimated in the US to be opioid dependent.  Currently, Suboxone sublingual film is the only available film formulation of buprenorphine and naloxone and is estimated to have generated sales in excess of $1 billion dollars over the last 12 months. Bunavail, if approved by the FDA, would be the first buccal film formulation of buprenorphine/naloxone to enter the market. BDSI believes that Bunavail has the potential to generate annual peak US sales up to $250 million.

Bunavail is the first and only buccal (adhering to the inside of the cheek) formulation of buprenorphine and naloxone and has been developed for the maintenance treatment of opioid dependence.  Bunavail utilizes BDSI's proven and patent-protected BioErodible MucoAdhesive (BEMA) drug delivery technology.

Buprenorphine, the active ingredient in Bunavail, is poorly absorbed orally from the gastrointestinal tract; however, it is absorbed within the oral cavity transmucosally (across the cheek or under the tongue).  Buprenorphine reduces the craving and withdrawal effects from the dependent opioid, and the opioid antagonist, naloxone, is present to deter abuse.

The NDA for Bunavail is supported by a bioequivalence study versus Suboxone and an open-label safety study in 249 patients switched from Suboxone film or tablets to Bunavail.

BDSI is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics.