FDA Approves Opioid Dependence Treatment

Officials with the FDA have approved the supplemental new drug application (sNDA) for BioDelivery Sciences International's buprenorphine and naloxone buccal film (Bunavail), which revises the indication to include its use for the initiation of buprenorphine treatment for opioid dependence.

Bunavail is the only bi-layer buccal film for the treatment of opioid dependence. It was previously only indicated for the maintenance treatment phase of opioid dependence treatment. The approved indication expands Bunavail's use to include induction, or the initial process used when a patient is transitioned from the abused opioid to the dose of Bunavail, which can provide relief from cravings and withdrawal for patients.

Bunavail should be used as part of a complete treatment plan that includes counseling and psychosocial support, according to a statement from BioDelivery Sciences.¹

Bunavail buccal film's safety is supported by clinical trials that evaluated buprenorphine and naloxone sublingual tablets, as well as other studies using buprenorphine tablets and buprenorphine sublingual solutions. In a phase 3 clinical study that assessed 249 patients who were converted from suboxone to Bunavail, the latter film formulation demonstrated favorable safety and efficacy in the maintenance treatment of opioid dependence.

Common adverse effects noted with Bunavail include headache, drug withdrawal synrome, lethargy, sweating, constipation, decrease in sleep, fatigue, and sleepiness.

Reference

1. BioDelivery Sciences announces the approval of Bunavail for induction of buprenorphine treatment for opioid dependence [news release]. BDSI's website. http://bdsi.investorroom.com/2017-05-02-BioDelivery-Sciences-Announces-the-Approval-of-BUNAVAIL-R-for-Induction-of-Buprenorphine-Treatment-for-Opioid-Dependence. Accessed May 2, 2017.