近日Pozen公司与GSK公司共同宣布接到了美国FDA对Trexima的可批准，Trexima为一种复方抗偏头痛药，为舒马坦琥珀酸盐+萘普生钠组成的复方制剂。
FDA肯定了Trexima对急性偏头痛的有效性，但是FDA对Trexima的安全性出了要求，有可能需要进行附加试验来提供安全性数据。公司将与FDA讨论可批准信中提到的问题。
每片Trexima中含有85mg的舒马坦琥珀酸盐（采用了RT技术）+萘普生钠500 mg，这是首种包括了抗炎与血管舒张两种作用机理的抗偏头痛药物。

Trexima（舒马坦和萘普生）复合片剂
Trexima是一具有独特双重作用机制的偏头痛治疗药物，其实为由5-羟色胺-1B和1D激动剂舒马坦和非甾体抗炎药物萘普生组成的一种复合片剂。Trexima将是其开发商Pozen有限公司进人市场的第一个药品，G1axoSmithKline公司则因已获许可而将拥有该药的独占性销售权。有关试验业已表明，Trexima的临床疗效优于G1axoSmith Kline公司的舒马坦。后者作为现在全球最为畅销的偏头痛治疗药物，其即将于2008年失去专利保护。Trexima 在美提出的用于偏头痛急性治疗的新药申请已于 2005年10月被FDA正式接受，预期它最早可在 2006年下半年内获得批准并上市。

Trexima应用了Pozen有限公司的MT 400技术。Trexima中的曲坦类药物能够改变血管收缩，由此缓解偏头痛疼痛。而其含有的非甾体抗炎药物则可抑制负责生产疼痛和炎症介质的前列腺素的酶，进而提高偏头痛症状缓解的速度、疗效和持续时间。

Trexima这一多作用机制药物可能提供偏头痛患者重要的治疗选择。偏头痛在美国影响到2800 万人以上，其中妇女患者约占全部病例的四分之三。按照国际头痛学会的诊断标准，偏头痛是一种持续4～72小时（不予治疗的话）且伴有包括中至重度头痛、悸动性头痛、位于头一侧的头痛、会经日常活动恶化的头痛、恶心、呕吐及对光和声音敏感等症状在内的复发性头痛。偏头痛具有致残性，其患者常会因为发病而不能工作、被迫放弃与家人和朋友欢聚的时光、甚或难于从事基本的日常活动。

两项关键性的Ⅲ期试验显现，Trexima治疗能较现行标准疗法舒马坦统计学显著性地提高患者的无痛响应率及其持续时间。舒马坦现被批准用于治疗成人偏头痛急性治疗；萘普生的获准适应证则包括类风湿性关节炎、骨关节炎、强直性脊椎炎、青少年关节炎、键炎、滑囊炎、急性痛风治疗及疼痛和原发性痛经管理等。

Brand names: Trexima™

Naproxen; Sumatriptan tablets

What are Naproxen; Sumatriptan tablets?

NAPROXEN; SUMATRIPTAN is used to treat migraines with or without aura. An aura is a strange feeling or visual disturbance that warns you of an attack. This medicine is not used to prevent migraines.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
• angina
• cigarette smoker
• diabetes
• heart disease
• hemiplegic or basilar migraine
• high blood pressure
• high cholesterol
• if you frequently drink alcohol containing drinks
• irregular heartbeat
• ischemic bowel disease
• kidney disease
• liver disease
• low blood counts, like low white cell, platelet, or red cell counts
• lung or breathing disease, like asthma
• peripheral vascular disease like intermittent claudication
• seizures
• stomach problems
• stroke
• take medicines that treat or prevent blood clots
• taken an MAOI like Carbex, Eldepryl, Marplan, Nardil, or Parnate in last 14 days
• an unusual or allergic reaction to Naproxen; Sumatriptan, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should this medicine be used?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Do not cut, crush, or chew this medicine. Do not take it more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What drug(s) may interact with Naproxen; Sumatriptan?

Do not take this medicine with any of the following medications:
• amphetamine
• cidofovir
• cocaine
• dextroamphetamine
• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine
• feverfew
• ketorolac
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• tryptophan

This medicine may also interact with the following medications:
• alcohol
• angiotensin-converting enzyme inhibitors (ACE inhibitors) like captopril, enalapril, lisinopril, and ramipril
• aspirin and aspirin-like medicines
• diuretics
• duloxetine
• lithium
• medicines for blood pressure like amlodipine, felodipine, nifedipine
• medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
• methotrexate
• NSAIDS, medicines for pain and inflammation, like ibuprofen or naproxen
• probenecid
• selective serotonin reuptake inhibitors such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline
• steroid medicines like prednisone or cortisone
• venlafaxine

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Naproxen; Sumatriptan?

Only use this medicine for a migraine headache. Use it if you get warning symptoms or at the start of a migraine attack. This medicine is not for regular use to prevent migraine headaches. Tell your doctor or health care professional if your pain does not get better. Talk to your doctor before taking another medicine for pain. Do not treat yourself.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Do not take medicines such as ibuprofen and naproxen with this medicine. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many medicines available without a prescription should not be taken with this medicine.

This medicine does not prevent heart attack or stroke. In fact, this medicine may increase the chance of a heart attack or stroke. The chance may increase with longer use of this medicine and in people who have heart disease. If you take aspirin to prevent heart attack or stroke, talk with your doctor or health care professional.

This medicine can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Do not smoke cigarettes or drink alcohol. These increase irritation to your stomach and can make it more susceptible to damage from this medicine. Ulcers and bleeding can happen without warning symptoms and can cause death.

This medicine can cause you to bleed more easily. Try to avoid damage to your teeth and gums when you brush or floss your teeth. If you have any dental work done, tell your dentist you are receiving this medicine.

What side effects may I notice from receiving Naproxen; Sumatriptan?

Side effects that you should report to your doctor or health care professional as soon as possible:
• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
• breathing difficulties
• changes in vision
• chest pain
• confusion, trouble speaking or understanding
• fast, irregular heartbeat
• feeling of chest heaviness or pressure
• general ill feeling or flu-like symptoms
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• seizures
• swelling of the ankles, feet, hands
• severe stomach pain
• slurred speech or weakness on one side of the body
• sudden numbness or weakness of the face, arm or leg
• tingling, pain, or numbness in the face, hands or feet
• trouble walking, dizziness, loss of balance or coordination
• unusual bleeding or bruising
• unusually weak or tired
• yellowing of eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
• dry mouth
• heartburn
• nausea, vomiting

Where can I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.