FDA OKs Bunavail for Induction of Opioid Addiction Treatment

Megan Brooks

May 02, 2017

The US Food and Drug Administration (FDA) has approved BioDelivery Sciences International's supplemental new drug application (sNDA) for Bunavail (buprenorphine and naloxone) buccal film, the company said today.

The sNDA allows for use of Bunavail at the start of buprenorphine treatment for opioid dependence. Previously, the indication for Bunavail only covered the maintenance phase of treatment for opioid dependence.

"The approval broadens the indication for Bunavail to include induction, or the initial process undertaken when a patient is transitioned from the abused opioid responsible for their addiction to the dose of Bunavail which is intended to provide relief from cravings and withdrawal," the company said in a news release.

Bunavail is indicated for the treatment of opioid dependence and should be used as part of a complete treatment plan that includes counseling and psychosocial support, the company said.

Bunavail may cause severe breathing problems, overdose, and death, particularly when taken intravenously in combination with benzodiazepines, sedatives, tranquilizers, or alcohol. Bunavail should be kept out of reach of children, the company advises in a patient medication guide.

Taking Bunavail before the effects of other opioids (eg, heroin, methadone, oxycodone, morphine) have lessened may lead to withdrawal symptoms. Dose reduction of central nervous system depressants, Bunavail buccal film, or both should be considered in settings involving concomitant prescription. Like other opioids, Bunavail may produce orthostatic hypotension in ambulatory individuals.

Common side effects of Bunavail include headache, drug withdrawal syndrome, lethargy, sweating, constipation, insomnia, fatigue and sleepiness.

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