BioDelivery Sciences International has received approval of the NDA for BUNAVAIL (buprenorphine and naloxone) buccal film (CIII) from the 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. BDSI expects to launch BUNAVAIL late in the third quarter of 2014.

BUNAVAIL was designed using BDSI's advanced drug delivery technology, BioErodible MucoAdhesive (BEMA), allowing for the efficient and convenient delivery of buprenorphine, while potentially overcoming some of the administration challenges presented by the sublingual (under the tongue) dosage forms currently available. BUNAVAIL has twice the bioavailability (drug absorbed into the body) of buprenorphine compared to Suboxone, the market leader in this category.

As a result of the improved absorption of buprenorphine with BUNAVAIL, which is the direct result of the BEMA technology, plasma concentrations of buprenorphine comparable to Suboxone can be achieved with half the dose, which may help to reduce the potential for misuse and diversion and potentially lessen the incidence of certain side effects.

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.

"BUNAVAIL is a novel treatment approach for the more than two million people in the U.S. afflicted with opioid dependence," said Gregory Sullivan, M.D., Principal Investigator of the phase III BUNAVAIL safety study and an addiction specialist and medical director of Parkway Medical Center in Birmingham, Ala. "BUNAVAIL utilizes advanced drug delivery technology to fulfill an important need for treatment options with improved drug absorption and patient convenience, and as such, may help to address some of the challenges associated with sublingual administration and possibly help improve treatment compliance."

Sullivan continued, "BUNAVAIL was assessed in a phase III clinical study in 249 patients who were converted from Suboxone sublingual tablet or film to BUNAVAIL. In this study, BUNAVAIL demonstrated favorable safety and efficacy in the maintenance treatment of opioid dependence as demonstrated by the high study retention rate and the low frequency of patients with positive urine tests for non-prescribed opioids over the 12-week period. The majority of patients who participated found BUNAVAIL easy to use and pleasant in taste. Additionally, prior to conversion to BUNAVAIL, about 40% of patients were experiencing constipation while receiving Suboxone tablet or film, a common problem with chronic opioid use, and more than two-thirds of these patients reported resolution of symptoms when they switched from Suboxone to BUNAVAIL."

BUNAVAIL is the first mucoadhesive buccal film formulation of buprenorphine to compete directly with Suboxone sublingual film. In 2013, sales of Suboxone sublingual film increased to more than $1.3 billion in the U.S. while the total market grew to more than $1.7 billion, driven by a 14% increase in prescriptions, according to data from Symphony Health Solutions.

BDSI 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 also will begin entertaining commercial partnerships for BUNAVAIL outside of the U.S. In March, BDSI entered into an agreement with Quintiles to support the launch of BUNAVAIL. 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. In the U.S., nearly 5,000 physicians are responsible for approximately 90% of prescriptions for buprenorphine products for the treatment of opioid dependence, according to recent data from Symphony Health Solutions.