Prescription Drug Person Charge Act (PDUFA) motion date set for 23 Might 2023
Lund, Sweden — 8 December 2022 — Camurus (NASDAQ STO: CAMX) introduced immediately that the US Meals and Drug Administration (FDA) has accepted for evaluation the New Drug Utility (NDA) for Brixadi* (buprenorphine) extended-release injection for subcutaneous (SC) use (Schedule III Managed Substance) for the remedy of reasonable to extreme opioid use dysfunction. The NDA was resubmitted to the Company by Camurus’ licensee Braeburn on 23 November 2022. The brand new Prescription Drug Person Charge Act (PDUFA) motion date is ready for 23 Might 2023.
About Brixadi(TM) (buprenorphine) extended-release injection for SC use (CIII)
Brixadi is an investigational, extended-release SC injectable remedy underneath evaluation in the USA by the US FDA for the remedy of reasonable to extreme opioid use dysfunction in sufferers who’ve initiated remedy with a single dose of a transmucosal buprenorphine product or who’re already being handled with buprenorphine. If accepted, Brixadi can be used as a part of a whole remedy plan to incorporate counseling and psychosocial assist. Brixadi will likely be obtainable by means of a Threat Analysis and Mitigation Technique (REMS) program and administered solely by healthcare suppliers in a healthcare setting.
Throughout the scientific improvement program, the protection profile of Brixadi was usually according to the recognized security profile of oral buprenorphine apart from injection-site reactions. The most typical hostile reactions (occurring in ≥5% of sufferers) related to Brixadi administration included injection-site ache, headache, constipation, nausea, injection-site erythema, injection-site pruritus, insomnia and urinary tract infections.
The product is already obtainable within the EU, Nice Britain, Australia, and several other different markets, underneath the commerce identify Buvidal®.1
Camurus is a Swedish science-led biopharmaceutical firm dedicated to creating and commercializing progressive and differentiated medicines for the remedy of extreme and persistent circumstances. New drug merchandise with best-in-class potential are conceived based mostly on the corporate’s proprietary FluidCrystal® drug supply applied sciences and its in depth R&D experience. Camurus’ scientific pipeline consists of merchandise for the remedy of dependence, ache, most cancers, and endocrine illness, developed in-house and in collaboration with worldwide pharmaceutical firms. The corporate’s shares are listed on Nasdaq Stockholm underneath the ticker CAMX. For extra data, go to www.camurus.com.
For extra dataFredrik Tiberg, President & CEO
Tel. +46 (0)46 286 46 92
Fredrik Joabsson, Chief Enterprise Growth Officer
Tel. +46 (0)70 776 17 37
1. Buvidal SmPC, September 2021: https://www.ema.europa.eu/en/paperwork/product-information/buvidal-epar-product-information_en.pdf
*The product rights to Brixadi(TM) in North America are licensed to Braeburn Inc. by Camurus AB.
This data is data that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation. The data was submitted for publication, by means of the company of the managing director, at 11:00 pm CET on 8 December 2022.
(c) 2022 Cision. All rights reserved., supply Press Releases – English