- PROBUPHINE® is also listed for reimbursement through the Non-Insured Health Benefit (NIHB) and Veteran Affairs Canada drug plans
- PROBUPHINE® is the first and only buprenorphine implant approved in Canada for the long-term maintenance management of opioid dependence in patients clinically stabilized on no more than 8 mg of sublingual buprenorphine in combination with counseling and psychosocial support.1
MONTREAL, Feb. 11, 2020 — Knight Therapeutics Inc. (TSX:GUD) (“Knight”), a leading pan-American (ex-USA) specialty pharmaceutical company, announced today that PROBUPHINE®, the first and only subdermal implant approved in Canada, is now additionally publicly funded in Quebec, New Brunswick, Newfoundland and Nova Scotia 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. In addition, Manitoba has announced that it will add PROBUPHINE to the Manitoba Drug Benefits Formulary as of March 2nd, 2020.
“This new coverage is a step forward in responding to the opioid crisis in Quebec”, said Dr Andrew Bui-Nguyen, who practices addiction medicine at Clinique Accueil Santé de Laval in Quebec. “PROBUPHINE® helps increase patient adherence, often a challenge in treatment, while alleviating the burden of daily pharmacy visits, allowing patients to focus on recovery.”
Approved by Health Canada in April 2018, PROBUPHINE® provides continuous, non-fluctuating blood levels of buprenorphine for up to six months, offering a convenient, confidential, safe and effective long-term treatment option to support stabilized patients throughout their recovery journey and allow them to regain a sense of normalcy in their lives. These five additional provinces now join public insurance plans administered by Alberta, Saskatchewan, Veterans Affairs Canada and the NIHB.
“For opioid use dependent patients like me, PROBUPHINE® means focusing on my life instead of focusing on how to get to the pharmacy that day,” said Georges S. Chartrand, Quebec PROBUPHINE® patient. “The best thing about PROBUPHINE® is waking up every day feeling normal.”
“We commend these provincial governments for their decision to publicly fund PROBUPHINE® for patients living with opioid dependence. Our hope is that other provinces will move quickly to make this new treatment option accessible as soon as possible through their respective public drug plans,” said Angie Hamilton, Executive Director and Co-Founder of Families for Addiction Recovery. “Families for Addiction Recovery believes that all Canadians recovering from addiction should have the right to treatment that is accessible, publicly-funded, timely, compassionate and evidence-based. Addiction does not discriminate. Neither should recovery.”
“These listing decisions highlight the value payers and clinicians see in Canada’s first and only subdermal buprenorphine implant for patients living with opioid use disorder,” said Jonathan Ross Goodman, Chief Executive Officer of Knight. “We hope to reach agreements with the remaining provincial public drug programs to ensure this important treatment option is accessible to patients across the country who can benefit on their journey to recovery.”
PROBUPHINE® must be inserted and removed by a healthcare professional who has successfully completed the PROBUPHINE® Education Program. Health care professionals from the Maritimes to British Columbia who have completed this live training program are now able to provide PROBUPHINE® to their patients across the country.
PROBUPHINE® is the only subdermal implant designed to deliver buprenorphine continuously for 6 months following a single treatment. PROBUPHINE® was developed using ProNeura™, a continuous drug delivery system developed by Titan Pharmaceuticals Inc. and 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. PROBUPHINE® must be inserted and removed by a healthcare professional who has successfully completed a live training program, the PROBUPHINE® Education Program. Knight Therapeutics Inc. obtained Health Canada approval for PROBUPHINE® in April 2018, the first buprenorphine implant for the long-term maintenance treatment of opioid addiction.
The efficacy and safety of PROBUPHINE® was evaluated in a double-blind double dummy pivotal phase III study (PRO-814). The most commonly reported adverse drug reactions (ADRs) in the PROBUPHINE® group, compared to 8 mg sublingual buprenorphine (SL BPN), were nasopharyngitis (6.3%), headache (5.1%), implant site pain (4.5%), and depression (4.5%). Incidences of individual TEAEs were generally low and comparable between treatment groups. The incidence of depression was lower in the SL BPN group (2.2%) compared with the PROBUPHINE® group (6.9%). A similar trend was observed for headache (3.4%, SL BPN; 6.9%, PROBUPHINE®) and implant site pruritus (1.1%, SL BPN; 4.6%, PROBUPHINE®).
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing innovative pharmaceutical products for Canada and Latin America. Knight owns a controlling stake in Grupo Biotoscana, a pan-Latin American specialty pharmaceutical company. 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.gud-knight.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, 2018. 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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1. PROBUPHINE® Product Monograph, Buprenorphine hydrochloride implant, Subdermal implant, 80 mg, Partial Opioid Agonist, March 1, 2019.