BDSI inks Canadian marketing deal
- BioDelivery Sciences International has made a deal with Purdue Pharma for exclusive Canadian marketing rights for BDSI's buccal buprenorphine formulation Belbuca.
- Purdue Pharma will distribute the recently-approved product across Canada, and will make upfront and milestone payments of up to CAD$4.5 million ($3.6 million) to BDSI, as well as undisclosed royalties on net sales.
- Belbuca's Canadian launch is expected in early 2018. The drug was approved by Health Canada in late-June for the long-term treatment and management of severe pain.
BioDelivery Sciences International got its rights for Belbuca back from its former licensee, Endo International, in December last year, when Endo pulled out of the deal as part of a major restructuring. BioDelivery Sciences relaunched Belbuca straight away, and reported weekly sales in June 2017 as exceeding the previous sales peak seen in December 2016. Belbuca is the subject of an agreement with CVS/Caremark, confirming access to Belbuca and BioDelivery Sciences' Bunavail (buprenorphine and naloxone buccal film).
The product is dosed once or twice daily and uses BioDelivery Sciences' BioErodible MucoAdhesive (BEMA) technology. This sticks to the inside of the cheek and releases buprenorphine into the bloodstream around the clock. As in the U.S., Canada has an opioid abuse problem of epidemic proportions. While BioDelivery Sciences doesn't make any claims about the abuse resistance of its BEMA technology, and in fact warns against the risk of addiction, abuse and misuse with opioids in its label, producing formulations that reduce the risk of accidental overdose or deliberate misuse will help by providing safer alternatives.
Relmada Therapeutics is developing REL-1028 (BuTab),an oral formulation of modified release buprenorphine for chronic pain. This has undergone a proof-of-concept clinical study. Braeburn Pharmaceuticals is carrying out clinical trials for CAM 2038, a subcutaneous injectable formulation of buprenorphine for the treatment of pain. This is in Phase 3 trials as a weekly or monthly injection. Probuphine, its 6-monthly buprenorphine implant, approved for use in opioid addiction, is in a Phase 2 study for pain.
- BioDelivery Sciences International Statement
- BioPharma Dive FDA to expand REMS for opioids in effort to slow epidemic
Follow Suzanne Elvidge on Twitter