Knight Therapeutics and Braeburn Pharmaceuticals seek Canadian approval for Probuphine
Health Canada has accepted a new drug submission for Probuphine, a subdermal buprenorphine implant intended for the treatment of opioid use disorder.
Knight Therapeutics and Braeburn Pharmaceuticals have submitted a new drug application to Health Canada for the approval of Probuphine. The treatment is a buprenorphine-releasing subdermal implant designed to manage opioid dependence over a six-month period following a single administration.
Unlike traditional daily sublingual or buccal formulations, Probuphine utilizes the ProNeura continuous drug delivery system to maintain consistent therapeutic levels. The product previously received regulatory approval from the U.S. Food and Drug Administration in 2016. Under a 2016 agreement, Knight holds the exclusive rights to distribute the implant within Canada.
CEO Jonathan Ross Goodman stated that the company aims to expand its portfolio of opioid supportive therapies. The move reflects broader efforts by pharmaceutical companies to provide alternatives that may mitigate risks associated with daily oral medications, such as accidental pediatric exposure and potential diversion.
The regulatory review process follows clinical trial results indicating that the implant is non-inferior to traditional sublingual buprenorphine treatments. Health Canada will now determine the product's suitability for the Canadian market.