2014年10月22日讯 /生物谷BIOON/ --武田（Takeda）与合作伙伴Orexigen公司近日联合宣布，在美国推出减肥新药Contrave（盐酸纳曲酮与盐酸安非他酮缓释片），该药是FDA于今年9月批准的一款减肥处方药，作为一种辅助药物，联合低热量饮食和运动，用于肥胖成人患者的体重管理。
FDA非常关心Contrave可能的神经和心血管副作用。因此，仅批准Contrave用于体质指数(BMI)≥30（肥胖）的患者，以及体质指数（BMI）≥27（超重）且至少伴有一种体重相关的合并症（如高血压、2型糖尿病、高胆固醇（血脂异常））的患者群体。同时，FDA在Contrave药物标签中标注了一个可怕的“黑框”警告，告诫医生和患者，Contrave可能提高自杀念头及其他精神疾病的风险。另外，FDA已要求Orexigen开展上市后的安全性和有效性研究，包括在儿童患者群体和伴有肝肾疾病的成人患者群体。在FDA的规定中，“黑框”是置于处方药标识中最严重的一种警告，也意味着禁止药企直接对消费者进行广告宣传。
这些限制因素，可能会对Contrave如何在快速增长的肥胖症药物市场中立足形成严峻挑战。除了要与市面上Arena公司和卫材（Eisai）的减肥药Belviq及Vivus公司的减肥药Qsymia抗衡之外，Contrave也将很快面临诺和诺德减肥新药Saxenda的竞争。而诺和诺德也一直在扩大美国的销售队伍，为Saxenda的上市做积极准备，最最关键的是，Contrave很难挑战Saxenda在临床试验中的数据：在4项研究中，Saxenda治疗组有超过60%的患者体重降低5%，有近33%的患者体重降低超过10%。
而根据FDA的声明，Contrave的获批，是基于Orexigen公司整体临床试验数据包，其中包括采集自约4500例患者的数据，其中一项试验，Contrave治疗组有42%的患者体重降低至少5%，而安慰剂组患者比例为17%。
尽管面临诸多挑战，但华尔街分析师预计Contrave的最终销售额仍可能突破10亿美元。富国银行分析师预测，到2020年，Contrave的销售额可达到6.34亿美元，但如果FDA批准Contrave治疗糖尿病，那么Contrave的销售额将达到12亿美元。
然而，从已上市减肥药反响平平的市场接纳来看，摆在武田和Orexigen面前的困难仍然严峻。Belviq和Qsymia均于2012年上市，前者截至今年3月的销售额仅为2500万美元，后者在2013年的年销售额也仅为2370万美元。武田与Orexigen于2010年9月签署了Orexigen研发协议，双方共同负责药物在美国、加拿大、墨西哥的商业化。
英文原文：Takeda and Orexigen Announce Availability of CONTRAVE® (naltrexone HCI and bupropion HCI) Extended-Release Tablets for Chronic Weight Management in Obese Adults
Contrave is now available by prescription, and Contrave patients also have access to the Scale Down program and Direct Save to help support their complete approach to weight management
DEERFIELD, Ill. and OSAKA, Japan, Oct. 20, 2014 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda"), its wholly-owned subsidiary Takeda Pharmaceuticals U.S.A., Inc. and Orexigen® Therapeutics, Inc. (OREX) jointly announced today that Contrave® (naltrexone HCI and bupropion HCI) extended-release tablets are now available to patients by prescription in pharmacies across the United States. Contrave is approved by the U.S. Food and Drug Administration (FDA) 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 comorbid condition (e.g., hypertension, type 2 diabetes mellitus or dyslipidemia).
"We're excited that Contrave is now available and that we are able to provide eligible patients with additional offerings," said Douglas Cole, president, Takeda Pharmaceuticals U.S.A., Inc. "These offerings include the Scale Down program, a support program for weight management, and Contrave Direct Save, which helps eligible patients to get Contrave at the lowest cost available to them, which can help to support a patient's complete approach to weight management."
Eligible patients taking Contrave will have access to the Scale Down program, which provides mobile weight management support with a wireless scale that triggers daily personalized texts based on weigh-ins. Scale Down, LLC is a company that is independent from Takeda and is solely responsible for the program content. Takeda will cover the membership costs associated with the Scale Down program for all eligible patients during the offer period.
In addition, eligible patients will have access to Contrave Direct Save, which provides the lowest cost available for both commercially insured and cash-paying patients, with one-on-one pharmacy support and the convenience of home delivery. When patients use the available savings offer, Contrave Direct Save provides progressive savings that begin on the third consecutive month of treatment if patients do not miss a refill. In addition to the Contrave Direct Save program, savings are also available to eligible patients through a Pharmacy Savings Card for those who prefer a retail pharmacy option.
Additional details about Contrave and the accompanying support and savings programs are available at www.Contrave.com/FAQ.
"Today is an exciting day for our team at Orexigen and our colleagues at Takeda as Contrave is now launched and available by prescription in pharmacies across the country," said Michael Narachi, CEO of Orexigen. "We're proud of our efforts working together to make this product available as a treatment option for appropriate patients."
Takeda and Orexigen entered into a collaboration agreement on September 1, 2010 for the development and commercialization of Contrave in the United States, Canada and Mexico. Under the terms of the agreement, Orexigen and Takeda agreed to work together on ongoing development of Contrave. Orexigen agreed to lead pre-approval development activities, and Takeda agreed to lead post-approval development activities. Orexigen originally submitted the New Drug Application (NDA) for Contrave to the FDA, which NDA was transferred to Takeda by Orexigen after Contrave was approved by the FDA on September 10, 2014.