- AB, SK and NIHB are the first public drug plans to fund PROBUPHINE® recognizing benefits of new treatment option
- 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 support1.
MONTREAL, Aug. 06, 2019 — Knight Therapeutics Inc. (TSX:GUD) (“Knight”), a leading Canadian specialty pharmaceutical company, announced today that it has reached an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA) for a Letter of Intent (LOI) regarding PROBUPHINE® (buprenorphine hydrochloride subdermal implant).
“Probuphine® provides a convenient, confidential and effective option for the treatment of opioid use disorder that can help patients overcome the barriers of daily adherence, including multiple pharmacy visits, giving them a sense of normalcy,” said Dr. Lionel Marks de Chabris, Assistant Professor at the Northern Ontario School of Medicine, and Chronic Pain and Addiction Specialist in Sudbury, Ontario. “The implant ensures that patients no longer need to worry about missing a dose, not getting a prescription or not getting to their pharmacy on time, which helps normalize their lives and reinforce their recovery.”
Subsequent to the agreement reached with pCPA, as at August 5, 2019, PROBUPHINE® is listed for reimbursement through the public insurance plans administered by Alberta, Saskatchewan and the Non-Insured Health Benefit (NIHB). Knight is actively working with other jurisdictions to finalize listings across the country to ensure Canadian patients have public access to this novel treatment option.
“The conclusion of negotiations with pCPA represents a major step in facilitating country-wide access of 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 look forward to working with the public drug programs to ensure this important treatment option is accessible to all those who can benefit from it in the last stage of 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 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, 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, July 26, 2019.