Indivior PLC, a global specialty pharmaceutical company, announced that it has filed a New Drug Submission (NDS) with Health Canada’s Therapeutic Drugs Directorate for Sublocade (buprenorphine extended-release) injection, for subcutaneous use, for the treatment of moderate to severe opioid use disorder (OUD) as part of a complete treatment plan to include counseling and psychosocial support. Health Canada granted Priority Review status for Sublocade on April 6, 2018. If approved, Sublocade will be marketed by Indivior Canada Ltd.
“The Priority Review designation is an important acknowledgment by Health Canada of the potential for Sublocade to help address the current unmet needs for patients living with opioid use disorder,” said Shaun Thaxter, chief executive officer of Indivior. “Indivior looks forward to working closely with regulatory authorities to ensure Sublocade, if approved, will be available as soon as possible to the Canadian treatment community to help address the current opioid public health crisis.”
In granting the Priority Review status for the Sublocade NDS, Health Canada noted that OUD is a serious, potentially life-threatening disorder and that there is substantial evidence of the clinical efficacy of Sublocade in the treatment of moderate to severe OUD. Health Canada also acknowledged that Sublocade has the potential to yield improved efficacy through enhanced adherence, due to its monthly administration.
A Priority Review designation indicates Health Canada’s goal to review the NDS within a shortened target of 180 calendar days. Priority Review designation may be granted to drug submissions intended for the treatment, prevention or diagnosis of serious, life-threatening or severely debilitating diseases or conditions for which there is substantial evidence that the overall benefit/risk profile is improved over existing therapies, preventatives or diagnostic agents for a disease or condition that is not adequately managed by a drug marketed in Canada.
The NDS submission of Sublocade to Health Canada follows approval of the drug by the US Food and Drug Administration (FDA) on November 30, 2017.
In Canada, Sublocade is an investigational product and its safety and efficacy is currently under review by Health Canada.
In the US, Sublocade is indicated for the treatment of moderate to severe OUD in adult patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of seven days. It should be administered only by healthcare providers and should be used as part of a complete treatment program that includes counseling and psychosocial support.
Sublocade uses the Atrigel delivery system, which consists of a polymeric solution of a biodegradable poly-(DL-lactide-co-glycolide) co-polymer dissolved in N-methyl pyrrolidone (NMP), a water-miscible biocompatible solvent. After subcutaneous injection, NMP diffuses out of the polymer matrix and the polymer precipitates, trapping the drug inside and forming an amorphous solid depot in situ. The depot releases buprenorphine over a one-month period by diffusion as the polymer biodegrades.
Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy and health policy while providing education on evidence-based treatment models that have revolutionized modern addiction treatment.