2008年4月美国FDA近日批准了葛兰素史克及其合作伙伴Pozen公司联合开发的偏头痛复方制剂Treximet/Trexima,这也是首种将曲坦类及镇痛药结合起来针对偏头痛多种发病机制的复方药物。 本品是首个和迄今唯一通过结合多种靶向作用机制的药品,将葛兰素史克公司先驱开发的特异性治疗偏头痛普坦类药物与消炎镇痛药结合在1片。剂量规格:舒马普坦/萘普生钠85mg/500mg/片。 在临床研究中,以速溶片(RT)技术制备的复方舒马普坦/萘普生钠片在2小时内解除偏头痛的百分比较单独服用舒马普坦85mg片或萘普生钠500mg片显著大。此外,服用此复方片2~24小时较单一用药可使更多的患者持续解除偏头痛。 偏头痛患者希望所服的药物奏效快和作用持久。美国FDA批准复方舒马普坦/萘普生钠片对偏头痛患者是好消息,因临床研究显示本品可持续解除绝大多数患者的偏头痛。本品经过充分的临床研究:治疗过3700例偏头痛患者3万次的偏头痛发作。 Treximet获准上市是基于对2900多例偏头痛患者2项相同的平行组随机双盲安慰剂对照多中心临床研究的数据。这些关键研究显示,复方舒马普坦/萘普生钠片在2~4小时解除偏头痛患者的例数较单独服用舒马普坦85mg、萘普生钠500mg或安慰剂多。重要的是,在这些研究中,Treximet可有效地解除偏头痛发作并作用可持续2~24小时。此外,与安慰剂相比,本品还可解除偏头痛引起的多种症状,如恶心和对光、声敏感等。 Treximet (Sumatriptan and Naproxen) Treximet is a tablet containing a combination of sumatriptan and naproxen. Sumatriptan is a headache medicine. It is believed to work by narrowing the blood vessels around the brain. Sumatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms. Naproxen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Naproxen works by reducing hormones that cause inflammation and pain in the body. Treximet is used to treat migraine headaches. Treximet will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks. Treximet should not be used to treat a migraine that causes visual aura (such as flickering lights) with weakness on one side of the body, speech problems, ringing in your ears. Treximet may also be used for other purposes not listed in this medication guide. Most impotant: Do not take more than 2 Treximet tablets in 24 hours. You should not use Treximet if you are allergic to sumatriptan (Imitrex) or naproxen (Aleve, Anaprox, Naprosyn), or if you have a history of asthma or allergic reaction caused by aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs). Do not take Treximet if you have liver disease, uncontrolled high blood pressure, or a history of heart disease, angina (chest pain), blood circulation problems, heart attack, stroke, or heart bypass surgery. Do not take Treximet if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), selegiline (Eldepryl, Emsam), or phenelzine (Nardil) in the past 14 days. Do not take Treximet within 24 hours before or after taking any of the following medications: almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), sumatriptan (Imitrex), or zolmitriptan (Zomig), or ergot medicine such as methysergide (Sansert), ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), methylergonovine (Methergine). |