BioDelivery Sciences Gets FDA Approval For Bunavail - Quick Facts

(RTTNews) - BioDelivery Sciences International Inc. (BDSI) said Monday that it received approval of the New Drug Application or NDA for bunavail (buprenorphine and naloxone) buccal film (CIII) from the U.S. Food and Drug Administration or FDA.

Bunavail is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. The company expects to launch bunavail late in the third quarter of 2014.

According to the company, Bunavail is the first and only formulation of buprenorphine and naloxone for buccal (inside of the cheek) administration. The ability of bunavail to stick on the inside of the cheek, unlike sublingual products that need to be kept in place under the tongue until they dissolve, allows patients to talk, swallow and go about normal daily activities while the medication is being consistently absorbed.

The company noted that it plans to launch bunavail in late third quarter 2014 and anticipates peak sales potential of bunavail of up to $250 million in the U.S. BDSI will also begin entertaining commercial partnerships for bunavail outside of the U.S. In March 2014, BDSI announced it had entered into an agreement with Quintiles to support the launch of Bunavail.

As per terms of the agreement, Quintiles will provide a range of services to support the launch and subsequent commercialization of bunavail in the U.S., including recruiting and training a field sales force.

Separately, BDSI has entered into an agreement with Ashfield Market Access to provide managed markets and trade support for bunavail. Ashfield Market Access, which is led by industry veterans including Steve Stefano, who led GlaxoSmithKline's managed markets group for more than 20 years, will be responsible for executing a payer strategy aimed at maximizing patient access to bunavail.