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https://www.wfmz.com/news/pr_newswire/pr_newswire_health/camurus-announces-submission-of-request-for-final-approval-of-brixadi-tm-for-the-treatment-of/article_0fd2e27e-96c8-5da2-957e-45d00f8af3fa.html

Camurus Announces Submission of Request for Final Approval of Brixadi(TM) for the Treatment of Opioid Use Disorder in the US

2020-06-04 15:27:04, Camurus AB, WFMZ.com

Content Categorization
/Business & Industrial/Pharmaceuticals & Biotech

Word Count:
678

Words/Sentence:
27

Reading Time:
6.78 min

Reading Quality:
Advanced

Readability:
16th or higher

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On 21 December 2018, Brixadi (the US trade name for Buvidal®) was tentatively approved by the FDA, having met all regulatory requirements regarding efficacy, safety and quality.

"With more than 2 million diagnosed patients and nearly 50,000 opioid overdose deaths in the US in 2018, the need for new and effective treatments of opioid use disorder is immense."

Brixadi has been tentatively approved by the FDA for the treatment of moderate-to-severe opioid use disorder in patients who have initiated treatment with a single dose of transmucosal buprenorphine or who are already being treated with buprenorphine.

Following the successes with Buvidal in Europe and Australia, we look forward to the forthcoming launch of Brixadi in the US as this will give patients access to an effective, long-acting treatment for opioid use disorder which is based on their individual needs and disease status," said Fredrik Tiberg, President and CEO of Camurus.

With today's request, Braeburn has submitted all updates for a final approval decision in the US on 1 December 2020."

Keywords
tri, fda, pha, hea, mtc, pr_newswire_health

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