Knight Therapeutics’ (TSX:GUD) New Drug Submission (NDS) for Probuphine, a subdermal implant of buprenorphine for the treatment of opioid drug dependence, has been accepted for review by Health Canada.
Knight and closely-held Braeburn Pharmaceuticals signed an exclusive distribution and sublicense agreement in February 2016, granting Knight the exclusive right to distribute Probuphine in Canada.
Probuphine was developed by Titan Pharmaceuticals (NASDAQ:TTNP) and is sold in the U.S. by Braeburn.
"With Probuphine, Knight is continuing to advance its portfolio of opioid-supportive therapeutics, which includes Movantik, a product for opioid-induced constipation we in-licensed from AstraZeneca and began commercializing in March of this year," Jonathan Goodman, CEO of Knight, said in a statement.
Mike Derkacz, president and CEO of Braeburn, said the Canadian filing is another important milestone for Probuphine, an innovative treatment approach with the potential to reduce the risks of diversion, abuse and accidental pediatric exposure. "We look forward to working with Knight and Health Canada to bring this important treatment option to Canadian patients."