FDA批准Orexigen/Takeda减肥新药Contrave

FDA批准Orexigen/Takeda减肥新药Contrave

                               
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发布日期：2014-09-11  来源：forbes  

美国食品药品监督管理局（FDA）9月10日宣布正式批准Orexigen Therapeutics Inc和武田制药合研减肥药Contrave（盐酸纳曲酮和盐酸安非他酮缓释片剂）。这是FDA在近12年以来第三个批准的口服减肥药。

　　

                               
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　　根据公告，该药物使用对象为BMI（即身体质量指数）超过30的成年人或者是BMI超过27，附有高血压、II类糖尿病或高胆固醇的成年人。

　　Orexigen Therapeutics Inc进行的Contrave临床试验共有4500患者参与，为期1年。试验结果显示，所有使用Contrave患者在1年之后体重下降4.1%，42%患者体重下降至少5%，远超过安慰剂的17%患者数量。

　　美国FDA同时附带黑框警告称，由于Contrave中含有安非他酮的成分，医师需警惕患者自杀风险几率可能会上升。除此之外，痉挛疾病患者、高血压患者都不得使用Contrave产品。

FDA Approves Contrave Weight Loss Drug From Orexigen And Takeda

The FDA announced today that it had approved Contrave, the long-awaited and much-disputed weight loss drug.  The drug is a combination of two drugs already approved for other indications: naltrexone hydrochloride, which is used to combat alcohol and opioid dependence, and bupropion, which is used to treat depression and seasonal affective disorder and as an aid to smoking cessation treatment. Contrave is manufactured by Orexigen and will be distributed by Takeda.

The FDA said that Contrave had been approved for use in obese adults (BMI of 30 or over) or overweight adults (BMI of 27 or over) with at least one weight-related condition such as high blood pressure, type 2 diabetes, or elevated cholesterol.

The  approval comes several years after the approval in 2012 of two competing weight loss drugs, Arena’s Belviq and Vivus’s Qsymia. Neither drug has achieved much success in the marketplace. Orexigen had originally hoped for an even earlier approval but it’s hopes were dashed in 2011 when the FDA demanded that the company perform a safety study.

In one clinical trial significant weight loss– defined as the loss of at least 5% of body weight– was achieved by 42% of people who received Contrave  and 17% of people who received placebo. In a trial of people with type 2 diabetes 36% of patients taking Contrave and 18% of patients taking placebo had a significant weight loss of at least 5% of body weight.

The FDA said that people taking Contrave should be evaluated after 12 weeks of treatment. Patients who have failed to lose at least 5% of their body weight should discontinue the drug.

Because Contrave contains buproprion, the label will include a boxed warning alerting physicians and patients to the increased risk of of suicidal thoughts and behaviors associated with antidepressant drugs.

The drug can also cause seizures and is contraindicated in people with seizure disorders. Contrave has also been found to increase blood pressure and should not be used in people with uncontrolled hypertension.

The FDA is requiring Orexigen to perform a cardiovascular outcomes trial and two safety and efficacy trials in pediatric populations.