电池供能的透皮贴剂Zecuity获准用于治疗偏头痛

圣路易斯(MD Consult)——2013年1月17日，NuPathe宣布美国食品药品管理局(FDA)已批准Zecuity(舒马曲坦电离子透皮系统)用于有或无先兆的成人偏头痛的急性期治疗。Zecuity可主动透过皮肤释放舒马曲坦，对于偏头痛本身和偏头痛相关恶心(MRN)均有缓解作用。

Zecuity是一种一次性使用的、由电池供能的贴剂，使用方法为发生偏头痛时将其贴在上臂或大腿上。按下启动按钮后，Zecuity即开始透皮释放活性药物。在长达4 h的整个给药过程中，Zecuity内置的微处理器会持续监测皮肤电阻并调节释药速度，以确保在尽可能减少患者间差异的情况下释放6.5 mg舒马曲坦。

Zecuity获得FDA批准是基于3期临床试验的结果，这些试验共招募了800例患者，使用了超过10,000份Zecuity贴剂。在这些试验中，Zecuity被证明可在激活2 h后安全有效地治疗偏头痛并缓解其主要症状(头痛、MRN和对声光敏感)。在一项3期关键性研究中，治疗2 h后，接受Zecuity治疗的患者头痛消失的比例高达对照组的2倍(18% vs. 9%)。

在接受Zecuity治疗的患者中，最常见不良反应为用药部位疼痛、刺痛、瘙痒、发热和不适。多数患者在移除Zecuity之后出现了皮肤发红，通常会在24 h内消失。

不得将Zecuity用于心脏病、心脏病或卒中病史、外周血管疾病、短暂性脑缺血发作(TIA)、血液循环问题、血压未得到控制、偏头痛导致短暂性偏瘫、基部偏头痛、沃尔夫-帕金森-怀特氏综合征或其他干扰心律疾病的患者。

假如患者在过去24 h内使用了麦角胺或其他曲坦类等其他偏头痛药物，或者在过去2周内使用了单胺氧化酶A抑制剂，就不得使用Zecuity。

爱思唯尔版权所有  未经授权请勿转载

ST LOUIS (MD Consult) - On January 17, 2013, NuPathe announced that the US Food and Drug Administration (FDA) has approved Zecuity (sumatriptan iontophoretic transdermal system) for the acute treatment of migraine with or without aura in adults. Zecuity actively delivers the triptan sumatriptan transdermally. Zecuity provides relief of both migraine headache pain and migraine-related nausea (MRN).

Zecuity is a single-use, battery-powered patch applied to the upper arm or thigh during a migraine. After application and with a press of a button, Zecuity initiates transdermal delivery. Throughout the 4-hour dosing period, the microprocessor within Zecuity continuously monitors skin resistance and adjusts drug delivery accordingly to ensure delivery of 6.5 mg of sumatriptan with minimal patient-to-patient variability.

Zecuity received FDA approval on the basis of results from phase 3 trials that included 800 patients who used more than 10,000 Zecuity patches. In these trials, Zecuity was proven safe and effective at treating migraine and relieving its cardinal symptoms (headache pain, MRN, and sensitivity to light and sound) 2 hours after patch activation. In one phase 3 pivotal study, twice as many patients treated with Zecuity achieved freedom from headache pain at 2 hours compared with placebo (18% and 9%, respectively).

The most common adverse effects in Zecuity-treated patients were application-site pain, tingling, itching, warmth, and discomfort. Most patients experience some skin redness after removing Zecuity. This redness typically resolves in 24 hours.

Zecuity should not be used in patients with heart disease, a history of heart disease or stroke, peripheral vascular disease, transient ischemic attack or problems with blood circulation, uncontrolled blood pressure, migraines that cause temporary paralysis on one side of the body or basilar migraines, or Wolff-Parkinson-White syndrome or other disturbances of heart rhythm.

Patients should not use Zecuity if they have taken other migraine medications such as ergotamine medications or other triptans in the last 24 hours, or if they have taken monoamine oxidase-A inhibitors in the last 2 weeks.