BioDelivery Sciences International (NSDQ:BDSI) said today that Health Canada approved its buprenorphine hydrochloride buccal film, Belbuca, for the management of pain severe enough to necessitate daily, long-term opioid treatment and for which alternative management options are inadequate.
The company said it plans to commercialize Belbuca in Canada through an unnamed partner and that the launch is set for early 2018.
“We are pleased to have a second significant regulatory approval for Belbuca as we move to expand availability of the product globally,” president & CEO Mark Sirgo said in prepared remarks. “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.”
For years, BioDelivery Sciences has developed mucoadhesive buccal films loaded with painkillers for pain management and addiction therapy. Now it is developing a buprenorphine depot injection that would maintain a particular drug concentration to treat opioid dependence or chronic pain for 30 days.
Sirgo told Drug Delivery Business News that the company hopes to bring the single-injection technology into its 1st-in-man study in the 3rd quarter of 2017.