PRINCETON, NEW JERSEY and MONTREAL, QUEBEC–(Marketwired – June 13, 2017) – Braeburn Pharmaceuticals, Inc. (“Braeburn”) and Knight Therapeutics Inc. (TSX:GUD) (“Knight”), a leading Canadian specialty pharmaceutical company, announced today that Knight’s New Drug Submission (NDS) has been accepted for review by Health Canada for PROBUPHINE® (buprenorphine subdermal implant) for the treatment of opioid drug dependence.
“Probuphine is a unique and innovative product that has the potential to address an important unmet need for opioid dependent patients,” said Jonathan Ross Goodman, Chief Executive Officer of Knight. “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.”
“Opioid addiction is an overwhelming public health epidemic in North America. This is another important milestone for Probuphine, an innovative treatment approach with the potential to reduce the risks of diversion, abuse and accidental pediatric exposure,” said Mike Derkacz, President and CEO of Braeburn. “We look forward to working with Knight and Health Canada to bring this important treatment option to Canadian patients.”
Knight and Braeburn signed an exclusive distribution and sublicense agreement in February 2016 granting Knight the exclusive right to distribute Probuphine in Canada.
Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months following a single treatment, and to promote patient compliance and retention. Buprenorphine, which is the active ingredient in multiple approved drug products for the treatment of opioid dependence, is currently available in sublingual and buccal formulations that require self-administration by patients on a daily basis.
Probuphine was developed using ProNeura™, the continuous drug delivery system developed by Titan Pharmaceuticals, Inc. (“Titan”) that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate (EVA) and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper arm in an outpatient office procedure, and removed in a similar manner at the end of the treatment period. Titan licensed the rights to commercialize Probuphine in the U.S. and Canada to Braeburn in 2012. Braeburn obtained Food and Drug Administration (“FDA”) approval for Probuphine in May 2016. Braeburn received a dedicated reimbursement code (J-Code) from the U.S. Centers for Medicare & Medicaid Services in January 2017 and deployed a new field force to expand commercialization efforts.
The efficacy and safety of Probuphine has previously been studied in several clinical studies. In July 2016, the results of the first comparative trial to evaluate efficacy and safety of a six-month buprenorphine implant relative to sublingual buprenorphine in patients with opioid use disorder were published in the Journal of the American Medical Association (JAMA). The study showed that Probuphine was non-inferior to sublingual buprenorphine on the primary endpoint of at least 4 of 6 months with no illicit opioid use by drug testing and self-report among opioid-dependent adults previously stabilized on sublingual buprenorphine.
Additionally, relative to participants using sublingual buprenorphine, participants maintained on Probuphine were more likely to sustain abstinence from illicit opioids. At 6 months, 85.7% of the Probuphine implant group remained abstinent each month relative to 71.9% of the sublingual buprenorphine group. In the Probuphine implant and sublingual buprenorphine groups, 81/84 (96.4%) and 78/89 (87.6%) of participants, respectively, were responders. While the trial was designed to assess non-inferiority, the buprenorphine implant was shown to be superior to sublingual buprenorphine based on the responder rate.
The most recent study enrolled 177 subjects who were randomized to receive either the Probuphine implants or sublingual tablets, for a treatment period of six months. Subjects in one group received four Probuphine implants plus daily placebo sublingual tablets. A second group received four placebo implants plus daily sublingual buprenorphine/naloxone tablets (=8mg/day).
The study met its primary objective of showing non-inferiority based on comparison of the proportion of treatment responders in each treatment arm. A responder was defined as having at least four out of six months free of illicit opiates based on urine testing and subject self-report. Additional analyses consistently demonstrated that Probuphine was non-inferior to sublingual buprenorphine/naloxone arm.
About Braeburn Pharmaceuticals Inc.
Braeburn Pharmaceuticals, an Apple Tree Partners company, is a commercial-stage pharmaceutical company delivering individualized medicine in neuroscience. Long-acting therapeutic treatment options can be essential to improving patient outcomes and facilitating recovery in neurological and psychiatric disorders, which are often complicated by stigma and present significant public health challenges. Braeburn’s commercial product, Probuphine® (buprenorphine) implant was approved by the FDA in May 2016. Braeburn’s investigational product pipeline consists of long-acting implantable and injectable therapies for serious neurological and psychiatric disorders, including opioid addiction, pain, and schizophrenia. Braeburn’s pipeline products are at various stages of clinical development and include weekly and monthly CAM2038, subcutaneous injection depot formulations of buprenorphine, being investigated in opioid addiction and pain, BB0417 buprenorphine/granisetron injectable for acute pain, and BB0817, six-month risperidone implant being investigated in schizophrenia. More information on Braeburn can be found at www.braeburnpharmaceuticals.com.
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, 2016. 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.
Probuphine Indication and Important Safety Information
Probuphine is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine-containing product (i.e., doses of no more than 8 mg per day of Subutex or Suboxone sublingual tablet or generic equivalent).
Probuphine should be used as part of a complete treatment program to include counseling and psychosocial support.
Probuphine is not appropriate for new entrants to treatment and patients who have not achieved and sustained prolonged clinical stability, while being maintained on buprenorphine 8 mg per day or less of a Subutex or Suboxone sublingual tablet or generic equivalent.