Knight Therapeutics Announces Canadian Regulatory Approval for PROBUPHINE™ for Opioid Drug Dependence
April 20 2018 - 4:01PM
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.”
About PROBUPHINE™
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.
Forward-Looking Statement
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.
For further information, please contact:
Knight Therapeutics Inc. Samira Sakhia President and Chief
Financial Officer Tel: 514-678-8930 Fax: 514-481-4116
Email: info@gudknight.com Website: www.gudknight.com
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