Phentermine Hydrochloride/Topiramate

一种实验药物使人们体重减轻 23%，仍然被视为令人失望？ 自 2017 年 Ozempic 获批用于治疗2 型糖尿病以来，制药商诺和诺德 (Novo Nordisk) 和礼来 (Eli Lilly) 一直在努力超越对方，推出更新、更有效的药物，以增强糖尿病和减肥效果，其药物类别为GLP-1 受体激动剂。 诺和诺德在减肥方面的最新尝试是一种名为 CagriSema 的组合药物，其达到了礼来公司目前批准的药物 Zepbound 设定的标准，但在周五报告的 后期临床试验结果中并没有完全超越它。 CagriSema的患者在68周后平均减轻了22.7%的体重，低于此前公司25%的预期水平。 这一结果导致诺和诺德股价暴跌约 20%，市值蒸发600多亿美元，约合4800亿元人民币。而其竞争对手肥胖药物制造商礼来公司的股票早盘涨幅超过5%。 未达预期 市值蒸发数百亿 CagriSema是诺和诺德开发的一种用于治疗肥胖症或超重成人的药物，它是一种固定剂量的复方制剂，包含长效胰淀素类似物cagrilintide 2.4 mg和GLP-1受体激动剂semaglutide 2.4 mg。这种药物设计为每周一次的皮下注射，通过减少饥饿感、增加饱腹感来帮助患者减少食量和降低卡路里摄入，从而实现体重减轻。 此前，诺和诺德已经公布了CagriSema在治疗2型糖尿病的II期临床试验中的积极结果，显示其不仅能有效降低糖化血红蛋白（HbA1c）水平，还具有显著的减肥效果。 而在近期诺和诺德最新公布的临床3期试验REDEFINE 1的主要结果中，CagriSema的患者在68周后平均减轻了22.7%的体重，低于此前公司25%的预期水平。 这项为期 68 周的研究显示，服用 CagriSema 的受试者体重减轻了约 23%，而单独服用卡格里林肽的受试者体重减轻了 12%，服用索马鲁肽的受试者体重减轻了 16%，服用安慰剂的受试者体重减轻了 2.3%。 这意味着这项研究达到了其主要目标，但那些密切关注减肥药物竞赛的人寄希望于 CagriSema 的平均减肥效果至少为 25%，这将为这个已经发生革命性变化的领域树立新的标杆通过GLP-1药物。 礼来公司的 Zepbound 于 2023 年 11 月获得批准，是这家总部位于印第安纳州的制药巨头对诺和诺德公司 Wegovy 的回应，在 3 期试验和礼来公司另一种实验药物的中期研究中，其最高剂量在 72 周后平均体重减轻了 21 %，称为瑞他鲁肽，仅 48 周后体重减轻 了24%。 诺和诺德负责开发的执行副总裁 Martin Holst Lange 在周五的公司新闻发布会上表示：“我们对 CagriSema 的减肥效果感到鼓舞，它在单一疗法中表现出优于索马鲁肽和卡格林肽的优势。”他表示，诺和诺德将利用该试验的见解“进一步探索 CagriSema 的额外减肥潜力”。 受此消息影响，诺和诺德 (Novo Nordisk) 的股价在周五早盘下跌约 19%，这家丹麦制药巨头的市值蒸发了数百亿美元。 CagriSema 的副作用似乎与 GLP-1 类其他药物相似；该公司表示，最常见的是胃肠道疾病，“绝大多数”是轻度至中度，并会随着时间的推移而消失。然而，只有一半多的参与者服用了最高剂量的药物，这导致一些人质疑这种组合在高剂量下是否可能不那么耐受。 诺和诺德表示，预计该药物的第二次 3 期试验（针对 2 型糖尿病患者）将于 2025 年上半年得出结果。 该研究于周五报道，诺和诺德将其称为“REDEFINE 1”，招募了肥胖或超重且至少有一种健康状况的人群——Wegovy 和 Zepbound 被批准用于减肥的同一人群。参与者开始时的平均体重为 106.9 公斤，约合 236 磅。 医学“军备竞赛” 诺和诺德的 Ozempic 和 Wegovy 基于活性成分 semaglutide，它模仿一种名为 GLP-1 的激素，对胰岛素分泌、消化和食欲很重要。Wegovy 在一项为期 68 周的临床试验中显示，它可以帮助人们平均减轻约 15% 的体重，并于 2021 年获得 FDA 批准。 礼来公司的 Mounjaro 和 Zepbound 分别于 2022 年和 2023 年批准用于糖尿病和减肥。他们使用活性成分替泽帕肽（tirzepatide）来增强效果，这种成分不仅模仿 GLP-1，还模仿另一种称为 GIP 的激素。 12 月初，礼来公司赞助的一项头对头试验证实了单独研究的结果，即 Zepbound 在 72 周内的平均减肥效果比 Wegovy 更大——分别为 20% 和 14% 左右。 有人将其描述为礼来公司和 Novo 之间的军备竞赛，竞争也给制药商及其投资者带来了好处。礼来公司的市值现已超过 7000 亿美元，在过去五年中翻了五倍，GLP-1 药物的年收入达数十亿美元。在此期间，诺和诺德的股价增长了两倍，达到 3000 亿美元以上。 从业者指出，该领域正在以令人难以置信的速度发展。 “我仍然记得 5%（减重）是我们的目标，我们对此感到高兴，”加州大学圣地亚哥分校肥胖和代谢研究所高级体重管理中心医学主任Eduardo Grunvald 博士表示。 以前的一批减肥药物，例如 Qsymia（不属于 GLP-1 类的旧药物的组合）和利拉鲁肽（一种以Saxenda品牌销售的早期 GLP-1 药物），最大减重效果为 8 %至 11%。 “使用这些较旧的药物，患者的期望将是改善他们的胆固醇、血糖水平或血压，索马鲁肽在 2021 年实现平均体重减轻约 15%，这将改变游戏规则”，从而改变“改善高血压、高脂血症和糖尿病等其他疾病的缓解”的临床益处。 体重减轻 25% 就可以达到减肥手术的效果。在诺和诺德 (Novo Nordisk) 的 CagriSema 试验中，40% 的参与者确实减轻了至少 25% 的体重，但这还不足以使试验的总体平均结果超过该基准。 五年前，如果说，诺和诺德将推出一种新药，让 40% 的人体重减轻 23%，那必然是一款非常出色的药物，但到 2024 年这个数据却非常令人失望，这表明了这个领域的发展速度非常快以及人们的期望非常高。 结语 减肥药市场的竞争持续升温，本月早些时候，诺和诺德遇到过另一个挫折，一项头对头临床试验显示礼来公司的 Zepbound 与 Wegovy 相比具有更好的减肥效果。 这项由礼来公司赞助的试验显示，72 周后，Zepbound 帮助患者平均减重 20.2%，即大约 50 磅，而 Wegovy 帮助患者在同一时期平均减重 13.7%。Novo 当时表示正在等待完整的数据。 而此次CagriSema的临床数据未达预期，更是给了诺和诺德又一沉重打击，但是诺和诺德方面表示仍然要看到新生的胰淀素类似物药物组作为下一阶段肥胖治疗的巨大潜力。 期待在这场以诺和诺德和礼来为主导的医学“军备竞赛”中，各自的减重产品会不断优化升级，朝着更有效而且健康的方向发展。 免责声明： 文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部责任。本公众号发布的各类文章重在分享，如有侵权请联系我们，我们将会删除。 联系我们 ABC 2025 展位火热预定中！ 扫码立即咨询 电话：13816031174 （同微信） 赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。 点击此处“阅读全文”咨询更多精彩

Collaborative telehealth platform will provide patients with immediate access to QSYMIA®, a chronic weight loss medication, enhancing their healthcare journey CAMPBELL, Calif., Oct. 30, 2024 (GLOBE NEWSWIRE) -- VIVUS LLC, a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs, and UpScriptHealth, a leading, nationwide, direct-to-consumer telemedicine company, today announced the launch of ChooseQ.online. This robust online telemedicine platform is designed specifically for distributing QSYMIA® (phentermine and topiramate extended-release capsules CIV), the leading non-injectable branded weight loss medication in the U.S. for adults. Under this collaboration, QSYMIA is now accessible to patients through UpScript LLC’s proprietary Telehealth Platform. QSYMIA is indicated as an FDA-approved adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in some adults and certain pediatric patients aged 12 years and older. “The launch of ChooseQ.online represents a significant milestone in our commitment to enhancing patient care and accessibility. We are thrilled to offer our patients the convenience they deserve,” said John Amos, CEO of VIVUS. “By leveraging UpScriptHealth’s expertise, within just a few clicks patients can now access medications, like QSYMIA, and consult with a physician from anywhere, ensuring that quality health care is always within reach.” ChooseQ.online offers the ability to: Access high quality health care and directly communicate with a healthcare providerHave medication mailed directly to patients through a mail order pharmacy, which offers patients a time-saving solution, or sent to a retail pharmacyProvide patient assistance with managing the coverage administration process through UpScriptHealth’s benefit support capabilities “Partnering with VIVUS marks a significant milestone in our joint commitment to technological innovation in healthcare. Together, we are redefining telehealth standards, offering patients nationwide a convenient, efficient, and personalized approach to managing their weight and health,” said Peter Ax, CEO and founder of UpScriptHealth. With over 20 years of experience and more than one million patients served, UpScriptHealth specializes in creating effective web-based campaigns for pharmaceutical companies. Its comprehensive services include virtual prescribing, coverage and benefit support, as well as long-term adherence support. For patients actively seeking online support and solutions, UpScriptHealth offers a fast and convenient option. “Our collaboration with UpScriptHealth ensures that patients receive the highest standard of care at a convenient time and location,” added Santosh T. Varghese, MD, President VIVUS Global Pharmaceutical Development and Chief Medical Officer at VIVUS LLC. “This initiative, paired with our recent labeling update, not only expands access to QSYMIA, but also empowers patients to proactively engage in their treatment plans, fostering long-term health outcomes.” The label update for QSYMIA removed specific body mass index (BMI) requirements and warnings or precautions regarding increase in heart rate, risk of hypoglycemia in people with type 2 diabetes taking anti-diabetic therapy, and risk of hypotension in people taking antihypertensive medication. The projected global impact of obesity is staggering, with an estimated one billion people expected to be affected by 2030. This marks nearly a twofold increase from around 511 million in 2020. Significantly, obesity escalates the risk of type 2 diabetes, hypertension, and dyslipidemia. Consequently, this heightened risk contributes to an overall increased susceptibility to cardiovascular disease and mortality. Achieving and maintaining healthy weight goals can play a crucial role in mitigating this risk. QSYMIA was approved by the U.S. Food and Drug Administration in 2012 for chronic weight management. The once-daily pill is covered by the majority (81%) of commercial healthcare plans and is indicated for long-term use. QSYMIA is designed to help patients manage hunger and reduce cravings throughout the day. Combined with a healthy diet and exercise, it has been proven to help patients lose weight and maintain weight loss. About VIVUS VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs. For more information about the Company, please visit http://www.vivus.com. About UpScriptHealthUpScriptHealth provides a fully compliant direct-to-consumer Telemedicine platform for pharmaceutical companies and consumer products companies. This unique platform allows for convenient access to high quality health care including state of the art medicines. In 2002 UpScriptHealth was the first company in the US to be licensed to write prescriptions on the internet through an online physician consultation. Since then, we’ve treated more than a million patients in all fifty states. Learn more at www.UpScriptHealth.com. About QSYMIA QSYMIA is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with obesity, and in adults with overweight in the presence of at least one weight-related comorbid condition The effect of QSYMIA on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of QSYMIA in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established. For more information on QSYMIA, please visit https://QSYMIA.com/ Important Safety Information for QSYMIA Do not take QSYMIA if you are pregnant, planning to become pregnant, or become pregnant during QSYMIA treatment; have glaucoma; have thyroid problems (hyperthyroidism); are taking certain medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the past 14 days; are allergic to topiramate, sympathomimetic amines such as phentermine, or any of the ingredients in QSYMIA. QSYMIA can cause serious side effects, including birth defects (cleft lip/cleft palate), serious eye problems (secondary angle closure glaucoma), visual field defects (independent of elevated intraocular pressure), suicidal thoughts or actions, and severe rash with blisters and peeling skin. QSYMIA may slow the increase in height in children 12 years and older. Common side effects of QSYMIA in adults include numbness or tingling in the hands, arms, feet, or face (paraesthesia), dizziness, changes in the way foods taste or loss of taste (dysgeusia), trouble sleeping (insomnia), constipation, and dry mouth. Common side effects of QSYMIA in children aged 12 years and older include depression, dizziness, joint pain, fever, flu, and ankle sprain. For more information please read the QSYMIA Medication Guide, Full Prescribing Information, and Risk of Birth Defects with QSYMIA patient brochure. Forward-Looking Statements Important Information and Cautionary Note Regarding Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and/or covered by the “Bespeaks Caution” doctrine applied by the courts under the antifraud provisions of the federal securities laws, and other applicable provisions of the federal securities laws. Such forward-looking statements are based on current expectations, management’s beliefs and certain assumptions made by the Company’s management. These statements may be identified by the use of forward-looking words such as “will,” “shall,” “may,” “believe,” “expect,” “forecast,” “intend,” “anticipate,” “predict,” “should,” “plan,” “likely,” “opportunity,” “estimated,” and “potential,” and/or the negative use of these words or other similar words. All forward-looking statements included in this document are based on our current expectations, and the Company assumes no obligation to update any such forward-looking statements except to the extent otherwise required by law. Forward-looking information about QSYMIA, including its potential benefits, approvals in potential markets outside the U.S. and anticipated product availability, involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied in this press release. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any other markets or approved, whether QSYMIA will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of QSYMIA; uncertainties regarding the impact of COVID-19 on our business, operations, and financial results; and competitive developments. The above factors, risks and uncertainties are difficult to predict, contain uncertainties that may materially affect actual results and may be beyond the Company’s control. New factors, risks and uncertainties emerge from time to time, and it is not possible for management to predict all such factors, risks and uncertainties. Although the Company believes that the assumptions underlying the forward-looking statements contained herein are reasonable, any of the assumptions could be inaccurate, and therefore any of these statements may prove to be inaccurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation or warranty by the Company or any other person that the Company’s objectives and plans will be achieved. These forward-looking statements speak only as of the date such statements were made or any earlier date indicated, and the Company does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes in underlying assumptions or otherwise, unless otherwise required by law. Contacts VIVUS LLCT: +1 (650) 934-5200 Media – FINN Partners Glenn Silver glenn.silver@finnpartners.com T: +1 973-818-8198