To combat severe pain for which alternative treatments fall short, BioDelivery Sciences International Inc.’s Belbuca (buprenorphine hydrochloride buccal film) product has gained approval from Canada’s regulatory body, Health Canada, earning its Notice of Compliance.
Belbuca is formulated to address discomfort requiring continuous long-term treatment on a daily basis. BioDelivery Sciences (BDSI) intends to market the medication in Canada with a partner company by early 2018. Company leaders expressed satisfaction with the approval, which helps to give the green light for commercial partnership.
"We are pleased to have a second significant regulatory approval for Belbuca as we move to expand availability of the product globally," BDSI president and CEO Dr. Mark Sirgo said. "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."
The product is intended as an alternative treatment option rather than marketed as an as-needed analgesic, company officials noted. Canada is the world’s second largest opioid consumer per capita; BDSI officials cited a 2015 survey revealing that 13 percent of the Canadian population has used opioid pain relief products in a one-year time period, noting that prescription opioid abuse in Canada resembles that of the U.S.
Based in Raleigh, North Carolina, BioDelivery Sciences specializes in pain management and addiction medicine for “critical and unmet needs,” according to spokespersons. The company works in tandem with FDA regulations to expedite new product approvals.
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