RALEIGH, N.C. – As drug abuse grows and drug addiction specialists seek new ways to treat opioid dependence, BioDelivery Sciences International (Nasdaq: BDSI) has positioned itself well in a surging marketplace with its new drug Bunavail.

BDSI has received approval for Bunavail from the U.S. Food and Drug Administration. The drug is indicated for the maintenance treatment of opioid dependence to be used as part of a complete treatment plan to include counseling and psychosocial support.

BDSI expects to launch Bunavail in the third quarter of this year.

On Jan. 24, BDSI and drug partner Endo Pharmaceuticals (NASDAQ: ENDP) said that Bunavail successfully met the primary clinical trial goal of significant chronic pain relief compared to a placebo. The companies said that secondary study targets also support BEMA buprenorphine’s case for efficacy when compared against a placebo.

BDSI recently raised $60 million to help commercialize Bunavail and also announced in May that said it had chosen Durham-based Quintiles (NYSE: Q), the world’s largest life science services firm, to help take the drug to market. The deal includes formation of a sales force. Financial terms of the agreement were not disclosed.

BDSI also selected the firm Ashfield Market Access to help it work with healthcare providers in payment strategies for the drug.

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 the drug 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.

“FDA’s approval of Bunavail is another example of how we are creating products to help patients in their battle to overcome debilitating medical issues such as opioid dependence and is a tribute to the dedication and focus of our employees,” said Dr. Mark A. Sirgo, president and CEO of BDSI. “This is also a transformative event for BDSI, as we will be launching a product with our own dedicated sales force for the first time, which we believe will lead to significant value creation for our shareholders.”

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 percent increase in prescriptions according to data from Symphony Health Solutions.

BDSI anticipates peak sales potential of Bunavail of up to $250 million in the United States. BDSI will also begin entertaining commercial partnerships for the drug outside of the U.S.

BDSI will be providing additional information regarding the FDA approval of Bunavail and commercialization plans in the upcoming weeks.