BioDelivery Sciences International Announces NDA Acceptance
BioDelivery Sciences International, Inc. recently announced that its NDA for BUNAVAIL (buprenorphine naloxone buccal film) for the maintenance treatment of opioid dependence has been accepted for filing by the US FDA, indicating 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 2 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 past 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.
BioDelivery Sciences International 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. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction. For more information, visit www.bdsi.com.
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