BioDelivery Sciences announces the approval of Bunavail for induction of buprenorphine treatment for opioid dependence

BioDelivery Sciences

2 May 2017 - BioDelivery Sciences announced that the U.S. FDA has approved a supplemental new drug application for Bunavail (buprenorphine and naloxone) buccal film (CIII) revising the indication to include the use of Bunavail for the initiation of buprenorphine 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. Induction is the first step to assist a patient in discontinuing or markedly reducing their use of other opioids. 

Previously, the indication for Bunavail only covered the maintenance treatment phase of opioid dependence treatment.

Read BioDelivery Sciences press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US