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
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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.
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|Date:||May 28, 2018|
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