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FDA Approves Opioid-Dependence Drug Bunavail

First buccal film formulation of buprenorphine and naloxone

The FDA has approved Bunavail (buprenorphine and naloxone buccal film [CIII]) for the maintenance treatment of opioid dependence. The product should be used as part of a complete treatment plan to include counseling and psychosocial support.

Bunavail was designed using BioErodible MucoAdhesive (BEMA) drug-delivery technology, which allows the delivery of buprenorphine while potentially overcoming some of the administration challenges presented by the sublingual dosage forms currently available.

According to the product’s developer (BioDelivery Sciences International, Inc.), bunavail offers twice the bioavailability of buprenorphine compared with that of Suboxone (buprenorphine and naloxone sublingual film, Reckitt Benckiser), the market leader for the treatment of opioid dependence. As a result of the improved absorption of buprenorphine with Bunavail, plasma concentrations of buprenorphine comparable with those of 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 formulation of buprenorphine and naloxone for buccal administration. The ability of the product to stick on the inside of the cheek — unlike sublingual products, which 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 was assessed in a phase III study of 249 patients who had been 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 shown by a high retention rate and a low frequency of patients with positive urine tests for non-prescribed opioids over the 12-week study period.

Moreover, prior to conversion to Bunavail, about 40% of patients were experiencing constipation while receiving Suboxone sublingual tablet or film — a common problem with chronic opioid use. More than two-thirds of these individuals reported the 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. The product is expected to launch in the late third quarter of 2014.

Source: BioDelivery Sciences International; June 9, 2014.

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