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FDA approves supplemental new drug application for opioid dependence agent Bunavail

The FDA has approved a supplemental new drug application for Bunavail, a bi-layer buccal film that helps treat opioid dependence, according to a statement from its manufacturer.

BioDelivery Science’s website states that the FDA’s decision expands the indication for Bunavail (buprenorphine and naloxone) to include the initial process undertaken when a patient is transitioned from the abused opioid to Bunavail, which is intended to provide relief from cravings and withdrawal, a process also known as induction. The company stated that induction is the first step to assist a patient in discontinuing or markedly reducing their use of other opioids.

“This new approval allows Bunavail to be prescribed from the very start of a patient’s course of treatment, meaning no transition from one course of treatment to another is required,” Mark Sirgo, PharmD, president and CEO, BioDelivery Sciences, told Healio Family Medicine.

According to BioDelivery Sciences, Bunavail, was only previously indicated for the maintenance treatment phase of opioid dependence treatment.

The company’s website states that Bunavail’s use is limited under the Drug Addiction Treatment Act. The film sticks to the inside of the user’s cheek, is easy to use, discreet, and allows the user to talk while it dissolves.

As the pharmaceutical industry takes steps to attempt to address the nation's opioid epidemic, the manufacturer noted the product's unique delivery system. 

“Bunavail, with its buccal administration, has been shown to be capable of delivering the same amount of buprenorphine with only half of the dose delivered with other formulations,” Sirgo said. “[We] believe that our unique and proprietary BioErodible MucoAdhesive drug delivery technology, incorporated into Bunavail, could make it less attractive for those who may be otherwise inclined to potentially misuse, abuse, or divert their treatment.”

Common adverse events from using Bunavail include fatigue, sleepiness, insomnia, constipation, sweating, lethargy, drug withdrawal syndrome and headache. - by Janel Miller

Disclosure: Sirgo is president and CEO of BioDelivery Sciences.

Editor's Note: This story has been updated from an earlier version to better reflect the product's delivery system.