Phentermine Hydrochloride/Topiramate

CAMPBELL, Calif., Jan. 12, 2026 (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, today announced it will provide updates to its pipeline and key program milestones during the 44th Annual J.P. Morgan Healthcare Conference 2026. “During the J.P. Morgan Healthcare Conference, VIVUS will share key highlights from 2025, demonstrating our commitment to advancing innovative clinical therapies across a variety of conditions,” said John Amos, Chief Executive Officer at VIVUS LLC. “The year was particularly transformative for QSYMIA, with new market approvals, expanded pharmacy partnerships, and more affordable pricing, broadening patient access to effective weight-management solutions. We also reached an important clinical milestone by enrolling over 20% of patients in our Phase 2 trial of VI-0609, an innovative ethanol-free formulation of carmustine, as part of high-dose conditioning chemotherapy for patients with refractory or relapsed Hodgkin or non-Hodgkin lymphoma undergoing autologous hematopoietic cell transplant. Looking ahead to 2026, we plan to initiate patient enrollment in our global pulmonary arterial hypertension, or PAH, clinical trial in Q1, involving 80 centers worldwide. Throughout all our efforts, we remain focused on disciplined execution and keeping patients at the center of every decision we make.” Key 2025 highlights include: Reduced QSYMIA price at Costco Pharmacies nationwide (October 7, 2025): The price of a 30-day supply of QSYMIA available via Costco Member Prescription Program at Costco Pharmacies nationwide was lowered to less than $99 for all doses.First patient enrolled in Phase 2 study assessing ethanol-free carmustine as a component of high-dose chemotherapy prior to transplant in patients with Hodgkin or non-Hodgkin lymphoma (April 14, 2025): VIVUS enrolled the first patient in a randomized, multicenter Phase 2 trial (NCT06915246) evaluating VI-0609 versus BiCNU as part of the BEAM high-dose conditioning regimen in patients with refractory or relapsed Hodgkin or non-Hodgkin lymphoma undergoing autologous hematopoietic cell transplant (AHCT), with the goal of improving safety and reducing infusion-related toxicities.Market approval of QSYMIA in the United Arab Emirates (March 10, 2025): QSYMIA is available to patients with overweight and obesity who could benefit from weight loss in the United Arab Emirates, the first country in the Middle East to approve and market QSYMIA(R).Continued progress toward expanding global availability of QSYMIA and QSIVA® (phentermine and topiramate modified-release): The Company is on track to launch its obesity management medication in additional European countries. “The past year represented an important period of execution for VIVUS, with meaningful progress across our commercial and clinical programs,” said Santosh T. Varghese, MD, President VIVUS Global Pharmaceutical Development and Chief Medical Officer at VIVUS LLC. “The Company advanced key milestones, including expanding access to QSYMIA and QSIVA internationally and initiating clinical development of our ethanol-free carmustine program, underscoring our commitment to improving patient outcomes through innovative formulations. As we look ahead to 2026, we are focused on disciplined clinical advancement, regulatory progress, and building on our momentum to deliver differentiated therapies for patients with serious unmet medical needs.” QSYMIA is the leading non-injectable branded weight loss medication in the U.S. for adults. QSYMIA is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate, indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight in some adults and certain pediatric patients aged 12 years and older. In addition to QSYMIA, VIVUS has continued to advance PANCREAZE®, indicated for EPI, a condition where the pancreas does not make enough enzymes to digest food normally. PANCREAZE is a pancreatic enzyme replacement therapy (PERT) that replaces the digestive enzymes that patients need. The PERT helps the body digest food properly and absorb fat, protein and carbohydrates, which are needed for healthy growth, weight gain and improved nutritional health. About VIVUSVIVUS 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 PANCREAZEPANCREAZE is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions. PANCREAZE may help your body use fats, proteins, and sugars from food. PANCREAZE contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas. PANCREAZE is safe and effective in children when taken as prescribed by your doctor. Important Safety Information for PANCREAZEWhat is the most important information I should know about PANCREAZE? PANCREAZE may increase your chance of having a serious, rare bowel disorder called fibrosing colonopathy that may require surgery.The risk of having this condition may be reduced by following the dosing instructions that your healthcare provider gave you. Call your doctor right away if you have any unusual or severe stomach area (abdominal) pain, bloating, trouble passing stool (having bowel movements), nausea, vomiting, or diarrhea. Take PANCREAZE exactly as prescribed by your doctor. Do not take more or less PANCREAZE than directed by your doctor. What are the possible side effects of PANCREAZE? PANCREAZE may cause serious side effects, including: A rare bowel disorder called fibrosing colonopathy.Irritation of the inside of your mouth. This can happen if PANCREAZE is not swallowed completely.Increase in blood uric acid levels. This may cause worsening of swollen, painful joints (gout) caused by an increase in your blood uric acid levels.Allergic reactions including trouble with breathing, skin rashes, or swollen lips. Call your doctor right away if you have any of these symptoms. The most common side effects include pain in your stomach (abdominal pain) and gas. Other possible side effects: PANCREAZE and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs. These are not all the side effects of PANCREAZE. Talk to your doctor about any side effect that bothers you or does not go away. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. What should I tell my doctor before taking PANCREAZE? Tell your doctor if you: are allergic to pork (pig) products.have a history of blockage of your intestines, or scarring or thickening of your bowel wall (fibrosing colonopathy).have gout, kidney disease, or high blood uric acid (hyperuricemia).have trouble swallowing capsules.have any other medical condition.are pregnant or plan to become pregnant.are breast-feeding or plan to breast-feed. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. The Product Information and Medication Guide for PANCREAZE is available at www.pancreaze.com. About QSYMIAQSYMIA 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/ About QSIVAQSIVA (the European brand name for QSYMIA) is approved in Sweden, Denmark, Finland, Iceland, Norway, and Poland. QSIVA is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. The effect of QSIVA on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of QSIVA in combination with other products intended for weight loss, including prescription and over-the-counter drugs and herbal preparations, have not been established. For more information on QSIVA, please visit www.QSIVA.eu. Important Safety Information for QSYMIADo 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 the Company's products and product candidates, including QSYMIA, QSIVA, VI-0609, and PANCREAZE, as well as the Company's clinical development programs and international expansion plans, involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied in this press release. Risks related to QSYMIA and QSIVA include the potential benefits of QSYMIA, approvals in potential markets outside the U.S., anticipated product availability, pricing strategies and their impact on revenue, the success of expanded pharmacy partnerships, international regulatory approvals and commercial launches in additional European countries and other markets, competitive developments in the weight management market including injectable medications, and whether QSYMIA and QSIVA will continue to be commercially successful. Risks related to VI-0609 include uncertainties inherent in clinical development and research, including the ability to enroll patients at anticipated rates, maintain enrollment momentum, meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, 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 clinical studies, whether and when drug applications may be filed in any markets for VI-0609, whether VI-0609 will receive regulatory approval, decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of VI-0609, and competitive developments in the oncology and transplant conditioning space. Risks related to the planned PAH clinical trial include the ability to initiate patient enrollment as planned in Q1 2026, challenges in establishing and coordinating approximately 90 clinical trial centers globally, patient recruitment and retention difficulties, regulatory approval requirements across multiple countries, potential delays in trial commencement or completion, and the uncertainties inherent in developing treatments for pulmonary arterial hypertension. General risks include uncertainties regarding the impact of COVID-19 or other public health emergencies on the Company's business, operations, and financial results; the ability to successfully manage multiple clinical and commercial programs simultaneously; regulatory submission dates, regulatory approval dates and/or launch dates for any product candidates; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of the Company's products; supply chain challenges; and competitive developments across all therapeutic areas in which the Company operates. 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

全球肥胖人群已突破 13 亿大关，这一庞大群体不仅面临体重困扰，更承受着代谢性疾病、心血管疾病乃至癌症等慢性健康问题的威胁，给各国医疗系统带来了沉重的负担。在此背景下，市场对新型高效肥胖治疗方案的需求日益迫切。 曾经专为 2 型糖尿病开发的 GLP-1 受体激动剂，凭借其显著的减重效果，彻底颠覆了传统肥胖治疗格局，掀起了新一轮的投资与研发热潮。如今，肥胖治疗的研究焦点已不再局限于单纯降低体重，而是向着追求持久的代谢改善与心血管保护等综合健康获益迈进。近日，《Nature Reviews Drug Discovery》杂志发表专题分析，深度剖析了肥胖药物领域快速演变的市场态势。一、当前肥胖治疗方案：从传统疗法困境到 GLP-1 类药物崛起（一）传统治疗方案的局限与挑战 生活方式干预作为肥胖管理的基础手段，单独实施时往往难以达到理想效果。减肥手术虽能实现最为显著的减重成效，但因其侵入性特点，仅适用于重度肥胖患者，难以普及。在药物治疗领域，早期疗法更是屡遭挫折，受限于疗效有限、安全性质疑及医保覆盖不足等问题。 早期肥胖药物多作用于中枢神经系统，例如去甲肾上腺能厌食剂苯丁胺、其与抗惊厥药托吡酯的复方制剂，以及抗抑郁药安非他酮与阿片拮抗剂纳曲酮的复方制剂等。这类药物减重效果中等，且因广泛作用于中枢神经，常伴随神经精神类副作用。另一类药物奥利司他则通过抑制膳食脂肪吸收发挥作用，虽安全性相对较高，但疗效有限且胃肠道耐受性较差。总体而言，这些传统疗法未能有效拓展市场规模，区域市场呈现分散状态。 更严重的是，多款肥胖药物因安全问题接连退市：利莫那班因可能增加自杀风险、西布曲明和芬氟拉明因存在心血管风险、氯卡色林因潜在致癌风险，这些事件严重打击了市场对肥胖药物的信心，让行业发展蒙上阴影。（二）GLP-1 类药物重塑治疗格局 GLP-1 受体激动剂的问世彻底扭转了肥胖药物市场的颓势。这类药物通过模拟调节食欲和能量代谢的肠道激素，实现了精准靶向作用，在心血管安全性和神经精神安全性方面展现出明显优势。 2014 年，利拉鲁肽获批肥胖适应症，成为肥胖治疗领域的关键转折点。此后，司美格鲁肽和替尔泊肽凭借更优的疗效和每周一次的给药便利性，在与利拉鲁肽价格相近的情况下，迅速抢占市场，推动肥胖药物销售额大幅增长。 司美格鲁肽于 2021 年在美国获批，可实现平均约 15% 的体重降低。它不仅是首个经 SELECT 试验证实具有心血管获益的减肥药，更是首个获批用于代谢功能障碍相关脂肪性肝炎治疗的 GLP-1 受体激动剂。这些突破性数据推动肥胖药物实现 “去肥胖化” 转型 —— 从单纯的形象管理工具，转变为能够挽救生命、保护器官的严肃治疗手段，有效化解了支付方的顾虑与社会对肥胖治疗的偏见。 替尔泊肽作为一种 GIP/GLP-1 双受体激动剂，疗效更上一层楼，平均减重幅度可达 20%，且耐受性良好。SURMOUNT-5 头对头试验已证实其疗效优于司美格鲁肽。除减重作用外，该药在肥胖合并心力衰竭或阻塞性睡眠呼吸暂停的患者中也显示出显著临床获益。目前，针对替尔泊肽治疗骨关节炎、慢性肾病、MASH、1 型糖尿病及心血管疾病效果的多项临床试验正在推进，未来有望凭借更广泛的适应症获得更有利的医保支付地位。二、现有主流药物的局限与新一代疗法的研发方向（一）主流 GLP-1 类药物的短板 尽管司美格鲁肽和替尔泊肽取得了巨大进步，但在临床应用中，其局限性也逐渐显现：减重效果会进入平台期，部分患者对药物应答不佳，且停药后体重易反弹。对于严重肥胖患者而言，15%-20% 的减重幅度可能仍无法满足治疗需求。 同时，业界开始关注减重 “质量” 问题。现有药物主要通过抑制食欲发挥作用，并未直接靶向脂肪组织、增加能量消耗或保护肌肉。快速减重过程中，总减重量的 15%-40% 可能来自肌肉流失，这对老年人或肌肉减少性肥胖患者尤为不利。此外，若缺乏配套的生活方式干预和长期监测，这种不健康的减重模式也令人担忧。（二）新一代肥胖疗法的研发策略与在研管线 这些挑战正驱动着新一代肥胖疗法的研发，新型疗法凭借新颖的作用机制和优化的药理学特性，旨在对现有 GLP-1 疗法进行补充和升级。 药物名称作用机制研发企业研发阶段CagriSemaGLP-1/胰淀素双激动剂诺和诺德III 期AmycretinGLP-1/胰淀素双激动剂诺和诺德II 期AZD6234胰淀素类似物阿斯利康II 期Petrelintide胰淀素类似物Zealand Pharma / 罗氏II 期MariTideGLP-1 受体激动剂/ GIP 拮抗剂安进III 期CT-388GLP-1/GIP 双激动剂罗氏II 期RetatrutideGLP-1/GIP/鸟苷酸环化酶 - C 三重激动剂礼来III 期SurvodutideGLP-1/胰高血糖素双激动剂勃林格殷格翰III 期AZD9550GLP-1/胰高血糖素双激动剂阿斯利康II 期PemvidutideGLP-1/胰高血糖素双激动剂AltimmuneII 期VK2735GLP-1/GIP 双激动剂Viking TherapeuticsIII 期口服司美格鲁肽GLP-1 受体激动剂诺和诺德预注册OrforglipronGLP-1 受体激动剂礼来III 期TERN-601GLP-1 受体激动剂Terns PharmaceuticalsII 期METO97GLP-1 受体激动剂MetseraII 期Trevogrumab生长分化因子 8 / 肌肉生长抑制素抑制剂再生元II 期BimagrumabII 型激活素受体阻滞剂礼来II 期Garetosmab激活素 A 抑制剂再生元II 期 下一代疗法的研发主要围绕五大核心策略展开： 多靶点激动剂研发：将 GLP-1 与胰高血糖素类似物结合，开发三重 / 双重激动剂（如 Retatrutide、Survodutide、Pemvidutide），在抑制食欲的基础上，进一步增加能量消耗、减少内脏脂肪，力求超越单一 GLP-1 受体激动剂的疗效。 胰淀素与 GIP 通路探索：聚焦胰淀素类似物和 GIP 调节剂（如 CagriSema、MariTide、Amycretin 等），尤其当与 GLP-1 联用时，有望更强效地抑制食欲并改善血糖稳态。 偏向性 GLP-1 激动剂开发：这类药物能选择性激活 cAMP 信号通路，同时限制 β- 抑制蛋白介导的受体脱敏，具备更强效、持久的疗效和更佳的胃肠道耐受性潜力。 肌肉保护策略落地：开发肌肉生长抑制素和激活素 / TGF-β 通路抑制剂，在 GLP-1 类药物带来快速减重的同时，靶向肌肉生长的关键负调控因子，保护瘦体重（肌肉），优化体成分，这对老年人等脆弱人群的长期健康至关重要。 依从性优化升级：一方面通过新机制改善恶心、呕吐等胃肠道副作用；另一方面，着力提升给药便利性，除现有每周注射剂型外，研发每两周或每月一次的长效注射剂及口服小分子药物，减轻患者治疗负担，助力长期坚持治疗。三、市场展望：规模激增与格局重构并存（一）市场规模预测 据预测，全球七大主要市场（美国、法国、德国、意大利、西班牙、英国和日本）的肥胖药物销售额将从 2023 年的 55 亿美元大幅增长至 2033 年的 570 亿美元，年复合增长率高达 26%。增长的核心驱动力来自高效药物的持续迭代、治疗率的不断提升以及市场准入的逐步扩大。不过，高昂的药价与庞大的适用人群，使得在现有模式下实现全民治疗在经济上尚不具备可行性。 图1. 主要市场肥胖药物销售额预估（传统药物包括：奥利司他、Contrave/Mysimba、Qsymia以及去甲肾上腺能厌食剂）（二）2033 年市场格局研判 预计到 2033 年，将有 5 款新疗法成功上市，分别是口服司美格鲁肽和 CagriSema（诺和诺德）、Orforglipron 和 Retatrutide（礼来）以及 Survodutide（勃林格殷格翰）。尽管 GLP-1 单激动剂仍将是市场增长的重要动力，但以替尔泊肽、CagriSema、Retatrutide 和 Survodutide 为代表的多受体激动剂预计将主导市场，贡献 2033 年总预计销售额的近 440 亿美元，占比达 77%。 具体产品市场表现预测如下： Wegovy（司美格鲁肽注射剂）：2024 年将保持销售领先地位，但随着竞品陆续上市，市场份额将逐步下降；2031-2032 年主要市场仿制药的上市有望缓和这一下滑趋势。 替尔泊肽：凭借卓越的减重疗效和在多种合并症中的积极临床数据，预计将成为并长期维持销售额和患者份额的领导者。 CagriSema：基于司美格鲁肽的成熟市场基础，有望被视为升级版疗法，持续推动诺和诺德在肥胖药物市场的增长。 Survodutide：由于胃肠道耐受性预期较低，且医生对胰高血糖素类似物相对不熟悉，市场接纳速度可能较慢；但如果其在 MASH 领域的开发项目取得成功，将成为合并 MASH 的肥胖患者的优选治疗方案，有望实现市场突破。 Retatrutide：虽上市时间相对较晚，但凭借三重激动机制带来的顶级疗效，预计将定位于治疗严重肥胖伴多种并发症的 “同类最佳” 疗法，占据重要市场份额。 口服制剂：在两款晚期口服 GLP-1 药物中，无需空腹服用且疗效媲美司美格鲁肽的小分子药物 Orforglipron 市场前景更被看好；而口服司美格鲁肽因需空腹服用及面临激烈竞争，市场渗透可能受到限制。小结 从传统疗法的举步维艰到 GLP-1 类药物的强势崛起，再到新一代多靶点、多功能疗法的加速迭代，肥胖治疗领域正经历前所未有的变革。当前及下一代肥胖药物凭借更优的疗效、创新的作用机制和潜在的协同效应，有望进一步拓宽肥胖症药物治疗的边界，为患者带来更全面的健康改善。随着市场竞争的不断加剧和技术的持续突破，肥胖治疗市场的快速迭代才刚刚拉开序幕，未来将为全球肥胖人群带来更多健康希望。 参考资料：Carles Recasens-Alvarez et al. The evolution of the obesity drug market. Nature reviews drug discovery（2025） 识别微信二维码，可添加药时空小编 请注明：姓名+研究方向！