美国FDA批准了近40年来的第一个用于治疗高尿酸症的痛风药物——武田制药的非布索坦（febuxostat；ULORIC）。非布索坦通过降低患者血液中的尿酸水平改善来痛风患者的症状。此外，武田制药北美公司还是该产品在美国市场中的独立开发商与销售商。

　　根据武田公司的一项声明：该产品的结构与40年前开发的黄嘌呤氧化酶抑制剂药物完全不同，它是一种全新的高效的非嘌呤类黄嘌呤氧化酶选择性抑制剂。黄嘌呤氧化酶则是促进尿酸生成的关键酶。

　　非布索坦可以降低高尿酸血症痛风患者血液中的尿酸水平，在临床研究中已经证明了非布索坦的安全性和有效性，而且在中、重度肝肾功能不全的患者中也不需要进行剂量调整。该产品的服用剂量为每日一次，一次40 毫克或者80毫克，但是该产品不推荐用于无高尿酸血症的痛风患者。

　　非布索坦的原研厂家为日本的另一家公司，日本帝人制药（TeijinPharma）。在帝人制药公司总裁最近的一份声明中，我们可以了解到该公司对该产品采取的全球战略。他说，在本品获得FDA的许可之前，Ipsen公司的产品也获得了欧盟的上市许可。Ipsen公司是帝人制药关于该产品在欧盟的许可公司，而武田北美制药是本品在美国的许可公司。所以公司在全球已经取得了里程碑式的战略意义。同时他还指出，在亚洲市场，帝人制药将采取自主开发或联合开发的形式。

　　据专家介绍，痛风是一组异质性疾病，是遗传性和（或）获得性引起的尿酸排泄减少和（或）嘌呤代谢障碍。临床特点：高尿酸血症，以及尿酸盐结晶，沉积所致的特征性急性关节炎、痛风石、间质性肾炎、严重者呈关节畸形及功能障碍；常伴尿酸性尿路结石。假性痛风常常与痛风混淆，因为其症状非常相似，假性痛风是由磷酸钙的代谢障碍引起，而不是尿酸代谢障碍引起。
　
　　根据美国国家关节肌肉骨骼疾病与皮肤病研究所（NIAMS）的研究数据表明，在美国有600万20岁及其以上的人生平有患痛风的经历。通常40~50岁的男性患者较为常见，而绝经前的女性患者少见。经历过器官移植的患者也容易患痛风。NIAMS指出下列药物会增加患痛风的风险：
　　（1）利尿剂：呋塞米（furosemide）、氢氯噻嗪（hydrochlorothiazide）、美托拉宗（metolazone）
　　（2）水杨酸类：如阿司匹林（aspirin）
　　（3）烟酸
　　（4）环孢菌素(CyclosporineNeoral)
　　（5）左旋多巴 (Levodopa)。

Important Safety and OtherInformation

ULORIC is a prescription medicine used to lower blood uric acid levels in adults with gout. Individual results may vary.

Do not take ULORIC if you are taking Azathioprine (Imuran®, Azasan®), Mercaptopurine (Purinethol®), or Theophylline (Theo-24®, Elixophyllin®, Theochron®, Theolair®, Uniphyl®).

For some people, gout may flare up when starting certain gout medicines, including ULORIC. If you have a flare while taking ULORIC, do not stop taking your medicine. Your healthcare provider may give you other medicines to help prevent your gout flares.

Heart Problems. A small number of heart attacks, strokes and heart-related deaths were seen in clinical studies. It is not certain that ULORIC caused these events.

Your healthcare professional may do blood tests to check your liver function while you are taking ULORIC.

The most common side effects are liver problems, nausea, gout flares, joint pain, and rash. 

Uloric - What You Need to Know
Uloric, generic name febuxostat, has been approved by the FDA for the chronic management of hyperuricemia in gout. Uloric is the first new treatment option for gout in over 40 years.

Uloric Recommended for FDA Approval
The FDA arthritis advisory committee has recommended the approval of Uloric for the treatment of gout. Uloric, the name that has been given to generic Febuxostat, was recommended by a 12-0 vote (one member of the committee abstained).

Febuxostat: More Effective Than Standard Drug
Febuxostat, a new treatment for gout, is at least twice as effective at lowering uric acid levels than allopurinol. Study results about febuxostat came from the largest and longest trial of gout drugs ever conducted.

Mismanagement of Gouty Arthritis Not Uncommon
Although gouty arthritis is not considered a difficult disease to diagnose and gout treatments are very effective in most cases, errors in the management of gout are common.

Gout - 10 Things You Should Know
Gout is an intensely painful type of arthritis. There are 10 important facts you should know about gout.

Fast Facts About Gout
Gout is one of the most painful types of arthritis. Gout is caused by uric acid crystals deposited in the body's tissues which lead to recurrent attacks of joint inflammation.

Gout Screening Quiz
Gout is one of the most painful types of arthritis. Do you have symptoms which are associated with gout? Do you have a lifestyle which increases the risk factors associated with gout? Take our Gout Screening Quiz.

Gout Risk Factor Quiz
A risk factor increases your chances of developing gout but it is not certain that you will develop the disease. What factors increase the risk of developing gout?

How to Recognize the Signs and Symptoms of Gout
Gout symptoms are very painful and are caused by monosodium urate crystals in joints and surrounding tissues. Gout symptoms can occur with more frequency if untreated.

The Gout Quiz - Test Your Knowledge of Gout
How much do you know about gout? You probably heard of it, but do you know the difference between purines and gout medication probenecid? Do you know what you need to do to prevent gout attacks? Does your lifestyle put you at risk for gout? Take the Gout Quiz and test your knowledge.

How To Treat Gout With Diet And Medication
Gout is one of the most painful types of arthritis. Gout attacks can be controlled or prevented by lifestyle changes and the use of certain medications.

The Gout Guide: Free E-Course Newsletter
We have designed our free newsletter e-course to guide you to better understand gout. Learn more about gout basics, gout history, gout cause, gout diagnosis, gout treatment, gout prevention, gout diet, gout medication, and gout research.

New Gout Drug Gets FDA Panel NodUloric, First New Gout Drug in 40 Years, Recommended for FDA Approval

By Daniel J. DeNoon

WebMD Health NewsReviewed by Louise Chang, MDNov. 24, 2008 --Uloric should be the first new gout drug to be approved in over 40 years, an FDA expert panel recommends.

Currently, allopurinol (trade name, Zyloprim) is the only FDA-approved drug that prevents formation of the uric acid crystals that cause gout. However, side effects -- including potentially fatal reactions -- limit the amount of allopurinol that can be tolerated. Most gout patients do not receive fully effective doses of allopurinol.

In clinical trials sponsored by Takeda, Uloric's manufacturer, an 80-milligram dose of Uloric worked better than allopurinol; a 40-milligram dose worked at least as well as allopurinol.

Unlike allopurinol, very little Uloric is excreted through the urine, making Uloric safe for patients with kidney problems. Gout patients with impaired kidney function have to take very low doses of allopurinol, making the drug even less effective for these patients.

In 2005, the FDA refused to approve Uloric because there were slightly more deaths and heart problems in patients taking the drug than in patients taking allopurinol. As people with gout problems already are at higher risk of heart disease, the FDA issued an "approvable" letter, noting that Uloric could be approved if this safety question were addressed.

Takeda then performed a large new phase 3 clinical trial that enrolled more gout patients than the two previous phase 3 trials combined. The new study found no more deaths and no more heart problems in patients taking Uloric than in patients taking allopurinol.

Based on the safety and efficacy data, the FDA panel recommended by a 12-0 vote that the FDA approve Uloric at both the 40-milligram and 80-milligram doses. Takeda suggests the higher dose is more effective in subjects with more severe gout.

Takeda has offered to continue studying Uloric after FDA approval. A phase 4 clinical trial would compare Uloric to allopurinol for the reduction of gout flare-ups.

And because drugs with the same mechanism of action as Uloric andallopurinol mayaffecttheophyllinebronchodilators,Takedahasagreedtoconductapostmarketing phase 1 study of Uloric's interactions with theophylline.

Gout occurs when blood levels of uric acid rise. At blood levels above 7 mg/dL -- and above 6 mg/dL in the extremities -- crystals can form that lodge in the joints and other body tissues. These crystal deposits provoke an immune response that results in extremely painful swelling and in inflammatory arthritis that can permanently destroy the joints.

(For more on the causes, symptoms, and treatment of gout, see WebMD's Gout Pictures Slideshow.)

About 1.4% of men and 0.6% of women have gout. But prevalence rises with age. After age 80, about 9% of men and 6% of women develop gout.

The body converts a chemical called xanthine into uric acid via an enzyme called xanthine oxidase or XO. Allopurinol and Uloric each inhibit XOandprevent the formation of uric acid.

Allopurinol is approved in doses up to 800 milligrams. However, it's rarely dosed above 300 milligrams per day and is often ineffective. Allopurinol side effects include upset stomach, headache, diarrhea, and rash. Although rare,allopurinol hypersensitivity syndrome can develop. It's fatal 20% to 30% of the time.

The most common side effects seen in patients taking Uloric during clinical trials were upper respiratory tract infections, muscle and connective-tissue symptoms, and diarrhea. The drug was well tolerated, and these side effects did not increase over long-term use.