Pickering, ON (Canada) (January 30, 2018): Purdue Pharma (Canada) and BioDelivery Sciences International Inc. (BDSI) announce today that BELBUCA® (buprenorphine buccal soluble film) is now commercially available in Canada. This follows authorization from Health Canada for transfer of ownership of the Drug Identification Number (DIN) for BELBUCA® to Purdue Pharma (Canada) in September 2017.
BELBUCA® (buprenorphine buccal soluble film) was authorized for sale in Canada on June 21, 2017 by Health Canada for the management of pain severe enough to require daily, continuous, long-term treatment and that is opioid-responsive and for which alternative options are inadequate. It is the first and only long-acting opioid that uses novel buccal film technology to deliver buprenorphine for appropriate patients living with chronic pain. Use of BELBUCA® is not indicated in patients under 18 years of age.
David Pidduck, President and Chief Executive Officer of Purdue Pharma (Canada), commented: “Canadians living with chronic pain manage significant, far-reaching burdens on a daily basis. Purdue Pharma (Canada) is committed to providing innovative and effective new treatment options that improve the lives of Canadian patients. BELBUCA® combines the innovation of buccal BioErodible MucoAdhesive (BEMA®) drug delivery technology with the unique pharmacology of buprenorphine.”
Scott Plesha, President of BioDelivery Sciences, commented: “We recognize that chronic pain is a serious concern for many Canadians as it is often debilitating and can significantly compromise a person’s quality of life. It was important for us to work with an organization that has a strong commitment to pain management in Canada, such as Purdue Pharma (Canada), and we are very pleased that BELBUCA® is now available to Canadian patients managing chronic pain.”
Uncontrolled chronic pain can often lead to longer lasting effects on a patient’s health. It is associated with the worst quality of life as compared to other chronic diseases with one in five Canadian adults suffering from chronic pain.
BELBUCA® (buprenorphine buccal soluble film) was approved by Health Canada for the management of pain severe enough to require daily, continuous, long-term treatment and that is opioid-responsive and for which alternative options are inadequate. BELBUCA® is an oral adhesive film that is placed in the patient’s cheek and delivers the complete dose of buprenorphine – which relieves pain by acting on specific nerve cells of the spinal cord and brain1 – when the film is fully dissolved in the mouth.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, which can lead to overdose and death, BELBUCA® should only be used in patients for whom alternative treatment options (e.g., non-opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Please consult the Product Monograph for complete administration, contraindications and safety information.
About BioDelivery Sciences International, Inc.
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a specialty pharmaceutical company with a focus in the areas of pain management and addiction medicine. BDSI is utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA®) technology and other drug delivery technologies to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs. BDSI’s marketed products and those in development address serious and debilitating conditions such as chronic pain, opioid dependence and breakthrough cancer pain. BDSI’s headquarters is in Raleigh, North Carolina. For more information, please visit: http://www.bdsi.com
About Purdue Pharma (Canada)
Purdue Pharma (Canada) is a research-based pharmaceutical and consumer healthcare company which has operated in Canada for over 60 years. Its 400 employees are committed to improving the health and quality of life of Canadians. The company has a broad portfolio of prescription and non-prescription medications including: prescription treatments for pain, ADHD, chemotherapy-induced nausea and vomiting (CINV), various ophthalmic conditions and OTC products. The company supports evidence-based education for the safe use of its products. Its headquarters, located in Pickering, ON, include integrated research & development, formulation and manufacturing operations. Privately held and founded by physicians, Purdue Pharma (Canada) is independently associated with the worldwide Purdue/Napp/Mundipharma network of companies. Learn more at www.purdue.ca
Sarah L. Robertson, Director of Communications
Purdue Pharma (Canada),
Pickering, ON, Canada
 Purdue Pharma (Canada), BELBUCA® (buprenorphine) buccal film Product Monograph, September 6, 2017