Knight Therapeutics Announces Canadian Regulatory Approval for PROBUPHINE™ for Opioid Drug Dependence
MONTREAL, April 20, 2018 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX:GUD)(“Knight”), a leading Canadian specialty pharmaceutical company, announced today that Health Canada has approved PROBUPHINE™ (buprenorphine subdermal implant) for the management of opioid dependence in patients clinically stabilized on no more than 8 mg of sublingual buprenorphine in combination with counseling and psychosocial support. Knight signed an exclusive distribution and sublicense agreement with Braeburn in February 2016 granting Knight the exclusive right to distribute PROBUPHINE™ in Canada.
“The approval of PROBUPHINE™ offers new hope in the fight against opioid dependence, a devastating public health crisis in Canada,” said Jonathan Ross Goodman, Chief Executive Officer of Knight. “We look forward to working with all stakeholders to make PROBUPHINE™ available to Canadian patients.”
“We are thrilled that PROBUPHINE™ has received approval by Health Canada,” said Mike Derkacz, President and CEO of Braeburn. “We look forward to working with Knight to do our part in helping patients with opioid dependence by expanding access to available evidence-based medication-assisted treatments.”
PROBUPHINE™ is the only subdermal implant designed to deliver buprenorphine continuously for six months following a single treatment. PROBUPHINE™ was developed using ProNeura™, the continuous drug delivery system developed by Titan Pharmaceuticals, Inc. that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate (EVA) and buprenorphine. Four implants are inserted subdermally in the inner side of the patient’s upper arm by a healthcare professional through an in-office procedure, and removed in a similar manner at the end of the treatment period. Braeburn obtained U.S. Food and Drug Administration approval for PROBUPHINE™ in May 2016 making it the first buprenorphine implant for the long-term maintenance treatment of opioid addiction.
About Knight Therapeutics Inc. Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and select international markets. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.gudknight.com or www.sedar.com.
This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2017. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events, except as required by law.
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Knight Therapeutics Inc.
Samira Sakhia President and Chief Financial Officer