23 June 2017 - BioDelivery Sciences announced that Health Canada, the regulatory authority in Canada, has issued a notice of compliance approving Belbuca (buprenorphine hydrochloride buccal film) for the management of pain severe enough to require daily, continuous, long-term treatment and is opioid responsive and for which alternative options are inadequate.
BioDelivery Sciences plans to commercialise Belbuca in Canada through a partner, and the approval is an important step in the partnering process.
Belbuca is expected to be launched in Canada in early 2018.