Belbuca is a buprenorphine buccal film 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.It was recently approved by Health Canada for the management of severe pain.
The medication incorporates BDSI’s BioErodible MucoAdhesive (BEMA) drug delivery technology. According to the company, Belbuca is the first and only long-acting opioid that uses novel buccal film technology to deliver buprenorphine for appropriate patients living with chronic pain.
Buprenorphine is an opioid used to treat opioid addiction, moderate acute pain, and moderate chronic pain. The combination buprenorphine/naloxone is also used for opioid addiction.
BDSI is using its novel and proprietary 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.
In return for the licensing and distribution rights to Belbuca in Canada, BioDelivery Sciences is eligible to receive upfront and potential milestones of up to $4.5 million as well as royalties on net sales.
BDSI chose to partner with Purdue because of the company’s long history of operation in the pain management area and its strong presence in the Canadian pain market said Dr. Mark Sirgo, president and CEO of BDSI.
“We look forward to our partnership with Purdue Pharma and expanding the reach of Belbuca to patients in Canada who are suffering from chronic pain,” he said. “The licensing of Belbuca Canada is a very important step for BioDelivery Sciences in broadening access to Belbuca beyond the U.S., and we look forward to the introduction of the product.”
The Pickering, Ont.-based Purdue is a research-based pharmaceutical company. Purdue is focuses in the research and development of medicines for the treatment of pain and central nervous system disorders (ADHD) and a growing pipeline of prescription and over the counter products.
Dr. Craig Landau, president and CEO, Purdue, said his company is confident that the potential benefits of the buprenorphine-containing product are significant.
“Belbuca provides physicians another safe and effective treatment option, when used as indicated, for Canadian patients, deemed appropriate for treatment, who suffer from long-term, chronic pain,” he said.
The mother company of Purdue Pharma (Canada), Purdue Pharma L.P. of New York, is the maker of the pain pill OxyContin. It also makes medicines such as hydromorphone, fentanyl, codeine, and hydrocodone.
Canada’s opioid crisis can be traced to the introduction of OxyContin as a prescription painkiller some 20 years ago.
The country’s opioid epidemic traces its roots to the introduction of the prescription painkiller 21 years ago. In May this year, Purdue Pharma agreed to pay $20 million to settle a class-action lawsuit involving as many as 2,000 Canadians who became addicted to physician-prescribed OxyContin.