Printer Friendly

Indivior updates the regulatory submission of SUBLOCADE Injection for opioid dependence in Australia.

M2 PHARMA-May 28, 2018-Indivior updates the regulatory submission of SUBLOCADE Injection for opioid dependence in Australia


Pharmaceutical company Indivior PLC (LON:INDV) revealed on Friday that it has filed a regulatory submission for SUBLOCADE (buprenorphine extended-release) injection for subcutaneous use in Australia for the treatment of opioid dependence within a framework of medical, social and psychological treatment.

Following approval by Australia's Therapeutic Goods Administration (TGA), SUBLOCADE will reportedly be marketed by Indivior Pty Ltd in Australia.

The SUBLOCADE TGA submission is reportedly based on the approval by the US Food and Drug Administration's (FDA) plus the successful the New Drug Submission (NDS) to Health Canada.

According to the company, the SUBLOCADE uses the ATRIGEL delivery system, a biodegradable poly-(DL-lactide-co-glycolide) co-polymer dissolved in N-methyl pyrrolidone (NMP), a water-miscible biocompatible solvent. 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.

In Australia, SUBLOCADE is still under review by the TGA, concluded the company.

((Comments on this story may be sent to

COPYRIGHT 2018 Normans Media Ltd.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2018 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:M2 Pharma
Geographic Code:8AUST
Date:May 28, 2018
Previous Article:Lion TCR announces USD20m from Series A financing round.
Next Article:Genmab reports stopping of studies of Daratumumab in combination with anti-PD-(L)1 by Janssen.

Terms of use | Privacy policy | Copyright © 2020 Farlex, Inc. | Feedback | For webmasters