BioDelivery Sciences International, Inc. (BDSI), a specialty pharmaceutical company,  announced that Health Canada, the regulatory authority in Canada, has issued a Notice of Compliance (NoC) 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.  

BDSI plans to commercialize 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.

"We are pleased to have a second significant regulatory approval for Belbuca as we move to expand availability of the product globally," said Dr. Mark A. Sirgo, president and chief executive officer of BDSI.  "We believe Belbuca offers important and distinctive advantages for those dealing with chronic pain, and we look forward to engaging with a commercial partner in Canada and for availability of Belbuca in the Canadian market in early in 2018."

Canada is the world's second largest per capita consumer of opioids with over 21 million prescriptions dispensed in 2014 and sales of over $880 million according to public data.  According to a 2015 survey, 13% of Canadians used opioid pain relievers within the previous year.  Much like in the US prescription opioid abuse and misuse have reached epidemic proportions in Canada, and Belbuca provides an alternative treatment option.

Belbuca (buprenorphine) buccal film is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioid formulations, reserve Belbuca® for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Belbuca is not indicated as an as-needed (prn) analgesic.

BioDelivery Sciences International, Inc. is a specialty pharmaceutical company with a focus in the areas of pain management and addiction medicine.