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Avicanna Announces Completion of Topical Gel Observational Real-World Evidence Study

Avicanna Announces Completion of Topical Gel Observational Real-World Evidence Study

Avicanna宣布完成外用凝胶观察性真实世界证据研究
GlobeNewswire ·  04/10 08:37

The study results revealed improvements in symptoms and quality of life in patients with musculoskeletal pain and inflammation

研究结果显示,肌肉骨骼疼痛和炎症患者的症状和生活质量有所改善

TORONTO, April  10, 2024  (GLOBE NEWSWIRE) -- Avicanna Inc. ("Avicanna" or the "Company") (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products is pleased to announce the completion of its observational real-world evidence ("RWE") study using RHO Phyto branded cannabigerol ("CBG") transdermal gel on patients with musculoskeletal pain and inflammation.

多伦多,2024年4月10日(GLOBE NEWSWIRE)——专注于植物衍生大麻素产品开发、制造和商业化的生物制药公司Avicanna Inc.(“Avicanna” 或 “公司”)(OTCQX:AVCNF)(FSE:0NN)很高兴地宣布其观察性现实世界证据已完成(“RWE”)使用RHO Phyto品牌的大麻比格罗(“CBG”)透皮凝胶对肌肉骨骼疼痛和炎症患者进行了研究。

The RWE study evaluated patient-reported efficacy of the RHO Phyto CBG Transdermal Gel containing 2% cannabidiol ("CBD") and 1% CBG on a range of clinical conditions including arthritis, osteoarthritis, rheumatoid arthritis, fibromyalgia, muscle and joint pain, localized pain, muscular and structural injuries, and post-surgical pain. Seventy-one participants completed baseline testing and a follow up at one month including demographic, medical history, medication use and two standardized symptom questionnaires.

莱茵集团的研究评估了患者报告的含有 2% 大麻二酚(“CBD”)和 1% CBG 的 RHO Phyto CBG 透皮凝胶对一系列临床疾病的疗效,包括关节炎、骨关节炎、类风湿关节炎、纤维肌痛、肌肉和关节痛、局部疼痛、肌肉和结构损伤以及术后疼痛。71名参与者在一个月内完成了基线测试和随访,包括人口统计、病史、药物使用和两份标准化症状问卷。

The RWE study revealed a meaningful improvement in overall Musculoskeletal Health Questionnaire scores (p<0.001) as compared from baseline to one month. Specifically, there was a reported 35.4% improvement in health-related domains including symptoms, physical functioning, daily activities and work, physical well-being, and confidence to manage symptoms. In addition, evaluation of the Edmonton Symptom Assessment System questionnaire also revealed an improvement in pain, sleep, anxiety, and well-being symptoms from baseline to one month (p<0.001).

莱茵集团的研究显示,与基线到一个月相比,肌肉骨骼健康问卷的总体分数(p

"The preliminary result of this study is in line with the reported results of our products with Canadian patients providing valuable insight for our next stages of clinical development. In parallel, this will propel our efforts under medical cannabis or cosmetic legislation internationally," stated Dr. Karolina Urban, Executive Vice President Medical Affairs.

“这项研究的初步结果与我们报告的产品结果一致,加拿大患者为我们下一阶段的临床开发提供了宝贵的见解。同时,这将推动我们在国际上根据医用大麻或化妆品立法所做的努力。” 医学事务执行副总裁卡罗琳娜·厄本博士说。

The RWE study participants with an average age of 58 ± 15 (64% women) all presented with symptoms of chronic pain. According to ICD-10 diagnosis classification, 21.1% of participants had a diagnosis related to arthritis (polyarthritis, osteoarthritis, etc.), 17.5% of participants with a diagnosis of dorsalgia, 12.3% with fibromyalgia, and 8% with chronic intractable pain. Prior to initiation of the study, study participants reported they were taking an average of ten medications including NSAIDs, opioids, antidepressants, or skeletal muscle relaxants. Each RWE study participant was assigned a common treatment plan of a combination of a CBD oil (83.3%) or balance oil (16.7%) with the RHO Phyto CBG Transdermal Gel.

RWE的研究参与者平均年龄为58±15(64%为女性)均出现慢性疼痛症状。根据 ICD-10 诊断分类,21.1% 的参与者的诊断与关节炎(多关节炎、骨关节炎等)有关,17.5% 的参与者被诊断为背痛,12.3% 的参与者被诊断为纤维肌痛,8% 的参与者患有慢性难治性疼痛。在研究开始之前,研究参与者报告说,他们平均服用十种药物,包括非甾体抗炎药、阿片类药物、抗抑郁药或骨骼肌松弛剂。每位莱茵集团研究参与者都被分配了将CBD油(83.3%)或平衡油(16.7%)与RHO Phyto CBG透皮凝胶混合的通用治疗计划。

About the RHO Phyto Transdermal CBG Gel

关于 RHO Phyto 透皮 CBG 凝胶

The CBG Transdermal Gel is a part of Avicanna's RHO Phyto formulary of medical products which includes proprietary oral, sublingual, and topical products containing a range of cannabinoids. The gel includes a combination of CBG and CBD in a fast-absorbing, water-based gel intended for application locally to area of focus. The gel utilizes Avicanna's deep tissue emulsion technology and combines cannabinoids with synergistic natural ingredients and terpenes including menthol, eugenol and beta-caryophyllene.

CBG 透皮凝胶是 Avicanna 的 RHO Phyto 医疗产品配方的一部分,其中包括含有一系列大麻素的专有口服、舌下和外用产品。该凝胶在快速吸收的水基凝胶中混合了CBG和CBD,旨在局部涂抹于重点区域。该凝胶利用Avicanna的深层组织乳液技术,将大麻素与协同天然成分和萜烯结合在一起,包括薄荷醇、丁香酚和β-石竹烯。

About Avicanna Inc.

关于 Avicanna Inc.

Avicanna is a commercial-stage international biopharmaceutical company focused on the advancement and commercialization of cannabinoid-based products and formulations for the global medical and pharmaceutical market segments. Avicanna has an established scientific platform including R&D and clinical development leading to the commercialization of more than thirty proprietary, evidence-based finished products and supporting four commercial-stage business pillars.

Avicanna是一家处于商业阶段的国际生物制药公司,专注于全球医疗和制药细分市场中基于大麻素的产品和配方的发展和商业化。Avicanna拥有成熟的科学平台,包括研发和临床开发,从而实现了三十多种基于证据的专有成品的商业化,并支持了四个商业阶段的业务支柱。

  • Medical Cannabis formulary (RHO Phyto): The formulary offers a diverse range of proprietary products including oral, sublingual, topical, and transdermal deliveries with varying ratios of cannabinoids, supported by ongoing patient, and medical community education. RHO Phyto is an established leading medical brand in Canada currently available nationwide to patients across several medical channels and continues to expand into new international markets.

  • 医用大麻处方集(RHO Phyto):该处方集提供各种专有产品,包括口服、舌下、局部和透皮给药,采用不同比例的大麻素,并由持续的患者和医学界教育提供支持。RHO Phyto是加拿大知名的领先医疗品牌,目前通过多种医疗渠道在全国范围内为患者提供服务,并将继续向新的国际市场扩张。

  • Medical cannabis care platform (MyMedi.ca): MyMedi.ca is a medical cannabis care platform formed with the aim to better serve medical cannabis patients' needs and enhance the patient journey. MyMedi.ca is operated by Northern Green Canada Inc. and features a diverse portfolio of products and bilingual pharmacist-led patient support programs. MyMedi.ca also provides specialty services to distinct patient groups such as veterans and collaborates with public and private payers for adjudication and reimbursement. MyMedi.ca provides educational resources to the medical community to facilitate the incorporation of medical cannabis into health care regimens.

  • 医用大麻护理平台(myMedi.ca):mymedi.ca是一个医用大麻护理平台,旨在更好地满足医用大麻患者的需求并改善患者旅程。Mymedi.ca 由加拿大北方绿色公司运营,提供多样化的产品组合和由药剂师主导的双语患者支持计划。Mymedi.ca 还为退伍军人等不同患者群体提供专业服务,并与公共和私人付款人合作进行裁决和报销。Mymedi.ca 向医学界提供教育资源,以促进将医用大麻纳入医疗保健方案。

  • Pharmaceutical products (Trunerox) and pipeline: Leveraging Avicanna's scientific platform, vertical integration, and real-world evidence, Avicanna has developed a pipeline of proprietary, indication-specific pharmaceutical products that are in various stages of clinical development and commercialization. These cannabinoid-based drug candidates aim to address unmet medical needs in the areas of dermatology, chronic pain, and various neurological disorders. Avicanna's first indication-specific pharmaceutical drug, Trunerox, was approved Q1 2024 by the Health Authority of Colombia INVIMA as an adjuvant treatment for seizures associated with Lennox-Gastaut Syndrome and Dravet Syndrome.

  • 制药产品(Trunerox)和产品线:利用Avicanna的科学平台、纵向整合和真实证据,Avicanna开发了一系列处于临床开发和商业化不同阶段的专有适应症特异性药物产品。这些基于大麻素的候选药物旨在解决皮肤病学、慢性疼痛和各种神经系统疾病领域未得到满足的医疗需求。Avicanna的首种适应症特异性药物Trunerox于2024年第一季度获得哥伦比亚卫生局INVIMA的批准,作为与伦诺克斯-加斯托特综合征和德拉维特综合征相关的癫痫发作的辅助治疗药物。

  • Active pharmaceutical ingredients (Aureus Santa Marta): Active pharmaceutical ingredients ("API") supplied by the Company's majority owned subsidiary Santa Marta Golden Hemp SAS ("SMGH") is a commercial-stage business dedicated to providing a various forms high-quality CBD, THC and CBG to the Company's international partners for use in the development and production of food, cosmetics, medical, and pharmaceutical products. The business unit also forms part of the Company's supply chain and is a source of reliable input products for its consumer retail, medical cannabis, and pharmaceutical products for globally.

  • 活性药物成分(Aureus Santa Marta):由公司控股子公司Santa Marta Golden Hemp SAS(“SMGH”)提供的活性药物成分(“API”)是一家商业阶段的企业,致力于向公司的国际合作伙伴提供各种形式的高质量CBD、四氢大麻酚和CBG,用于食品、化妆品、医疗和药品的开发和生产。该业务部门也是公司供应链的一部分,是其全球消费零售、医用大麻和药品的可靠投入产品的来源。

SOURCE Avicanna Inc.

来源 Avicanna Inc.

Stay Connected

保持联系

For more information about Avicanna, visit our website, contact Ivana Maric by email at info@avicanna.com or follow us on social media on LinkedIn, Twitter, Facebook, or Instagram.

有关Avicanna的更多信息,请访问我们的网站,发送电子邮件至 info@avicanna.com 联系伊万娜·马里奇,或在领英、推特、脸书或Instagram上的社交媒体上关注我们。

The Company posts updates through videos from the Company YouTube channel.

该公司通过公司YouTube频道的视频发布最新消息。

Cautionary Note Regarding Forward-Looking Information and Statements

关于前瞻性信息和陈述的警示说明

This news release contains "forward-looking information" within the meaning of applicable securities laws. Forward-looking information contained in this news release may be identified using words such as, "may", "would", "could", "will", "likely", "expect", "anticipate", "believe", "intend", "plan", "forecast", "project", "estimate", "outlook" and other similar expressions. Although the Company believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because the Company can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include but are not limited to current and future market conditions, including the market price of the common shares of the Company, and the risk factors set out in the Company's annual information form dated April 1, 2024 filed with the Canadian securities regulators and available under the Company's profile on SEDAR at . The statements in this news release are made as of the date of this release. The Company disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

本新闻稿包含适用证券法所指的 “前瞻性信息”。本新闻稿中包含的前瞻性信息可以使用 “可能”、“可能”、“将”、“可能”、“可能”、“期望”、“预期”、“相信”、“打算”、“计划”、“预测”、“项目”、“估计”、“展望” 等词语和其他类似表述来识别。尽管公司认为此类前瞻性信息所依据的预期和假设是合理的,但不应过分依赖前瞻性信息,因为公司无法保证这些信息将被证明是正确的。实际结果和发展可能与这些声明所设想的结果和事态发展存在重大差异。前瞻性信息受各种风险和不确定性的影响,这些风险和不确定性可能导致实际事件或结果与前瞻性信息中的预测存在重大差异。此类风险和不确定性包括但不限于当前和未来的市场状况,包括公司普通股的市场价格,以及公司于2024年4月1日向加拿大证券监管机构提交的年度信息表中列出的风险因素,可在SEDAR的公司简介中查阅。本新闻稿中的声明是截至本新闻稿发布之日发表的。除非适用的证券法要求,否则公司不承担任何更新任何前瞻性信息的意图或义务,无论这些信息是由于新信息、未来事件或业绩还是其他原因造成的。

声明:本内容仅用作提供资讯及教育之目的,不构成对任何特定投资或投资策略的推荐或认可。 更多信息
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