LUND, Sweden, June 25, 2024 /PRNewswire/ -- Camurus (NASDAQ STO: CAMX) today announced the publication in JAMA Network Open of a new post hoc analysis from a 24-week randomized, double-blind, Phase 3 study1 comparing weekly and monthly subcutaneous (SC) buprenorphine injections (Buvidal®/Brixadi®) to daily sublingual buprenorphine/naloxone (SL-BPN/NX).

瑞典隆德，2024年6月25日/PRNewswire/-Camurus（NASDAQ STO:CAMX）今天宣布在JAMA Network Open上发布了一项新的事后分析，该分析来自一项为期24周的随机，双盲，3期研究1，比较每周和每月皮下（SC）丁丙诺啡注射（Buvidal®/Brixadi®）与每日舌下丁丙诺啡/纳洛酮（SL-BPN/NX）。

The data presented suggests the effectiveness in individuals with opioid dependence who use fentanyl, consistent with the results from the Phase 3 study..

。。

'These findings are consistent with the Phase 3 data showing the effectiveness of extended-release buprenorphine in addressing opioid dependence, including among patients using fentanyl', says Edward V. Nunes, M.D., Professor of Psychiatry, Columbia University Irving Medical Center, Department of Psychiatry, NY, US.

美国纽约哥伦比亚大学欧文医学中心精神病学教授Edward V.Nunes医学博士说：“这些发现与第三阶段的数据一致，这些数据显示缓释丁丙诺啡在解决阿片类药物依赖方面的有效性，包括在使用芬太尼的患者中。”。

'Our research highlights its potential to offer an effective treatment for individuals grappling with dependence on opioids.'.

“我们的研究突出了它为依赖阿片类药物的个体提供有效治疗的潜力。”。

Of 428 trial participants, 123 (SC-BPN, n=64; SL-BPN/NX, n=59) had evidence of baseline fentanyl use. In the fentanyl-positive subgroup, the mean percentage of urine samples negative for fentanyl during the study was 74% for the SC-BPN arm versus 61.9% for the SL BPN/NX arm). Withdrawal symptoms and cravings decreased following treatment initiation in patients positive for fentanyl use at baseline.

在428名试验参与者中，123名（SC-BPN，n=64；SL-BPN/NX，n=59）有基线芬太尼使用的证据。在芬太尼阳性亚组中，研究期间芬太尼阴性尿液样本的平均百分比为SC-BPN组为74%，SL-BPN/NX组为61.9%。。

No substantial difference was observed in rates of study completion between fentanyl-positive and fentanyl-negative cohorts (60.2% and 56.7%, respectively). The safety profile of SC-BPN was comparable to the known safety profile of buprenorphine, with the exception of mild to moderate injection site reactions.

芬太尼阳性组和芬太尼阴性组的研究完成率没有显着差异（分别为60.2%和56.7%）。SC-BPN的安全性与丁丙诺啡的已知安全性相当，但轻度至中度注射部位反应除外。

'The publication features a unique data set collected during the wake of the fentanyl crisis in the US and suggests that buprenorphine, in particular weekly and monthly subcutaneous injections, is effective in treating opioid dependence including in patients who use fentanyl', says Fredrik Tiberg, President and CEO at Camurus..

Camurus总裁兼首席执行官弗雷德里克·蒂贝格（Fredrik Tiberg）表示：“该出版物以美国芬太尼危机后收集的独特数据为特色，表明丁丙诺啡，特别是每周和每月皮下注射，可有效治疗阿片类药物依赖，包括使用芬太尼的患者。”。。

The full publication 'Extended-Release Injection vs Sublingual Buprenorphine for Opioid Use Disorder with Fentanyl Use' is available online at JAMA Network Open today.2

完整的出版物“缓释注射液与舌下丁丙诺啡治疗芬太尼使用阿片类药物使用障碍”可在今天开放的JAMA网络在线获得。2

For more informationFredrik Tiberg, CEO & Head of R&DTel. +46 (0)46 286 46 92fredrik.tiberg@camurus.com

欲了解更多信息，Fredrik Tiberg，R＆DTel首席执行官兼主管+46（0）46 286 4692fredrik.tiberg@camurus.com

Fredrik Joabsson, Chief Business Development OfficerTel. +46 (0)70 776 17 37ir@camurus.com

弗雷德里克·乔布森（FredrikJoabsson），首席商业发展办公室（Certel）+46（0）70 776 1737ir@camurus.com

About Buvidal®

关于Buvidal®

Buvidal (buprenorphine prolonged-release solution for subcutaneous injection in prefilled syringe) is indicated for the treatment of opioid dependence within a framework of medical, social, and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.3Buvidal is available in four weekly strengths (8mg, 16mg, 24mg and 32mg) and four monthly strengths (64mg, 96mg, 128mg and 160mg), enabling treatment to be tailored to the patient's individual needs.

丁维达尔（丁丙诺啡缓释溶液，用于预填充注射器中的皮下注射）适用于在医学，社会和心理治疗的框架内治疗阿片类药物依赖。治疗计划用于16岁或16岁以上的成年人和青少年。3Buvidal有四周的强度（8mg，16mg，24mg和32mg）和四个月的强度（64mg，96mg，128mg和160mg），可以根据患者的个人需求进行治疗。

Administration of Buvidal is restricted to healthcare professionals, with the potential of increasing treatment compliance, and minimizing risks of diversion, misuse, and paediatric exposure. .

Buvidal的管理仅限于医疗保健专业人员，有可能提高治疗依从性，并最大限度地减少转移，滥用和儿科暴露的风险。。

Buvidal is approved for treatment of opioid dependence in the EU, UK, Switzerland, Australia, New Zealand and several countries in the Middle East and North Africa. In the US, the product is available under the tradename Brixadi through Camurus licensee Braeburn.

Buvidal在欧盟、英国、瑞士、澳大利亚、新西兰以及中东和北非的几个国家被批准用于治疗阿片类药物依赖。在美国，该产品的商标名为Brixadi，可通过Camurus许可证持有人Braeburn获得。

About Camurus

关于卡穆鲁斯

Camurus is a Swedish, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the company's proprietary FluidCrystal® drug delivery technologies and its extensive R&D expertise.

Camurus是一家以科学为主导的瑞典生物制药公司，致力于开发和商业化用于治疗严重和慢性疾病的创新长效药物。基于该公司专有的FluidCrystal®药物输送技术及其广泛的研发专业知识，构思出具有同类最佳潜力的新药。

Camurus' clinical pipeline includes products for the treatment of dependence, pain, cancer and endocrine diseases, which are developed in-house and in collaboration with international pharmaceutical companies. The company's shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com..

卡穆鲁斯的临床渠道包括用于治疗依赖、疼痛、癌症和内分泌疾病的产品，这些产品是内部开发的，并与国际制药公司合作开发的。该公司股票在纳斯达克斯德哥尔摩证券交易所以CAMX股票代码上市。有关更多信息，请访问www.camurus.com。。

References

参考文献

Lofwall, MR, et al. Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial. JAMA Intern Med. 2018;178(6):764-773. doi:10.1001/jamainternmed.2018.1052.

Lofwall，MR等人。每周和每月皮下丁丙诺啡贮库制剂与每日舌下丁丙诺啡联合纳洛酮治疗阿片类药物使用障碍：一项随机临床试验。JAMA实习生医学2018；178（6）：764-773。doi:10.1001/jamainternmed.2018.1052。

Nunes, E. V., et al. Extended-Release Injection vs Sublingual Buprenorphine for Opioid Use Disorder with Fentanyl Use. JAMA Network Open. 2024;7(6):e2417377. doi10.1001/jamanetworkopen.2024.17377.

Nunes，E.V。等人。使用芬太尼治疗阿片类药物使用障碍的缓释注射液与舌下丁丙诺啡。。2024年；7（6）：e2417377。doi10.1001/jamanetworkopen.2024.17377。

SmPC Buvidal, Aug 2023

SmPC Buvidal，2023年8月

This information was submitted for publication at 5:00 pm CET on 25 June 2024.

This information was submitted for publication at 5:00 pm CET on 25 June 2024.

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