LUND, Sweden, July 17, 2023 /PRNewswire/ -- Camurus (NASDAQ STO: CAMX) today announced topline, interim data from an open-label, long-term safety and extension trial, ACROINNOVA 2, assessing CAM2029, octreotide subcutaneous (SC) depot, in 135 adult patients with acromegaly. These include both new patients and roll-over patients from the previous randomized controlled trial, ACROINNOVA 1, where they received treatment with CAM2029 or placebo ('treatment naïve' patients). The Phase 3 data show a favorable safety profile and robust long-term efficacy over 52 weeks of treatment with CAM2029.
LUND, Sweden, May 24, 2023 /PRNewswire/ -- Camurus (NASDAQ STO: CAMX) today announces that the US Food and Drug Administration (FDA) has approved Brixadi™ (buprenorphine) extended release injection for subcutaneous (SC) use, a weekly and monthly medication for the treatment of moderate to severe opioid use disorder (OUD), in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a daily buprenorphine product. Brixadi should be used as part of a complete treatment plan that includes counseling and psychosocial support.1 The product will be marketed in the US by Camurus' licensee Braeburn.
Camurus, a Swedish science-led biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for the company's investigational medicinal product, octreotide subcutaneous depot (CAM2029), for the treatment of autosomal dominant polycystic liver disease.
Camurus announces PDUFA date for Brixadi for the treatment of opioid use disorder in the US
LUND, Sweden, June 15, 2021 /PRNewswire/ -- Camurus AB (NASDAQ STO: CAMX) today announced that its US licensee Braeburn has resubmitted the New Drug Application (NDA) for Brixadi1 (buprenorphine) extended-release weekly and monthly injections for the treatment of moderate to severe opioid use disorder to the US Food and Drug Administration (FDA).
LUND, Sweden, June 15, 2021 /PRNewswire/ -- Camurus AB (NASDAQ STO: CAMX) today announced that its US licensee Braeburn has resubmitted the New Drug Application (NDA) for Brixadi1 (buprenorphine) extended-release weekly and monthly injections for the treatment of moderate to severe opioid use disorder to the US Food and Drug Administration (FDA).
LUND, Sweden, May 10, 2021 /PRNewswire/ -- Camurus (NASDAQ STO: CAMX) announces today the publication in JAMA Network Open of results from a 24-week, randomized, controlled trial (DEBUT) comparing patient reported outcomes of opioid dependence treatment with subcutaneous weekly and monthly buprenorphine depot injections (Buvidal®) versus daily sublingual buprenorphine.
LUND, Sweden, May 3, 2021 /PRNewswire/ -- Camurus AB (NASDAQ STO: CAMX) today announced that the Australian regulatory agency, the Therapeutic Goods Administration (TGA), has approved key label updates to Buvidal® Weekly and Buvidal® Monthly (buprenorphine) modified-release solutions for injection.
For providing hospitality to a health professional after the health professional and Camurus staff had attended a football match together, Camurus was ruled in breach of the following clauses of the Code:
LUND, Sweden, June 1, 2020 /PRNewswire/ -- Camurus AB (NASDAQ: CAMX) (STO: CAMX) today announces that the company's US partner Braeburn has submitted a request for final approval of Brixadi™ (buprenorphine) weekly and monthly extended release injection for the treatment of opioid use disorder to the US Food and Drug Administration (FDA).