St. John's Mercy Health Care, St. Louis, MO, USA.
Headache. 2012 Apr;52(4):612-24. doi: 10.1111/j.1526-4610.2012.02094.x. Epub 2012 Feb 21.
To assess the long-term tolerability and efficacy of NP101, a novel transdermal sumatriptan patch being developed for the acute treatment of migraine.
Nausea (with or without vomiting) and gastroparesis have been characterized as being among the most problematic challenges affecting migraine care today. Migraine-associated nausea can cause patients to delay or avoid taking oral medication with a resultant loss or reduction of therapeutic efficacy. Migraine-associated gastroparesis can impair absorption and reduce bioavailability of oral migraine medications and thereby reduce and delay therapeutic efficacy. The non-oral triptan formulations that have been used to overcome these challenges are associated with other shortcomings that can limit their use. Designed to overcome these shortcomings and treatment limitations imposed by gastrointestinal signs and symptoms, the NP101 patch avoids the need for oral administration, does not depend upon gastrointestinal absorption, and provides more consistent, predictable plasma concentrations than oral and intranasal formulations of sumatriptan and a lower maximum plasma concentration than sumatriptan injection.
Patients diagnosed with migraine who had participated in a randomized, double-blind, Phase III study of the NP101 patch were given the option to use NP101 to treat migraine episodes with moderate or severe headache pain for up to 12 months in this open-label trial.
One hundred eighty-three patients applied 2089 study patches. The most common adverse events involved the patch application site (45% of patients). The only non-application-site adverse events reported in >2% of patients were nausea (n=6, 3.3%), upper respiratory tract infection (n=6, 3.3%), and nasopharyngitis (n=4, 2.2%). The incidence of triptan-associated adverse events was 1.6%. Across all visits for investigator assessments, the majority of patients (ranging from 74.7% at Month 1 to 92.2% at Month 9) were scored as having no erythema at patch application sites. For patient assessments, the percentage of patch placement sites scored as having no or minimal redness was 38.2% at the time of patch removal and 65.4% 24 hours after patch activation. Two hours after patch activation across all patch treatments over the 12-month study, 23.8% of initial acute migraine episodes were scored as being free from headache pain, 58.2% as having headache pain relief,78.9% as nausea free, 60.1% as phonophobia free, 53.4% as photophobia free, and 20.7% as migraine free. No evidence of waning tolerability or efficacy was observed over the 12-month study period.
NP101, a transdermal sumatriptan formulation in development for the acute treatment of migraine, demonstrated tolerability and efficacy with successive uses over 12 months in this clinical trial.
评估 NP101 的长期耐受性和疗效，NP101 是一种新型的曲坦透皮贴片，用于偏头痛的急性治疗。
恶心（伴或不伴呕吐）和胃轻瘫已被认为是当今影响偏头痛治疗的最具挑战性的问题之一。偏头痛相关的恶心会导致患者延迟或避免服用口服药物，从而导致治疗效果丧失或降低。偏头痛相关的胃轻瘫会影响口服偏头痛药物的吸收并降低其生物利用度，从而降低和延迟治疗效果。为了克服这些挑战而使用的非口服曲坦制剂存在其他限制其使用的缺点。NP101 贴片旨在克服这些缺点和胃肠道症状带来的治疗限制，避免口服给药，不依赖于胃肠道吸收，并提供比口服和鼻内制剂更一致、更可预测的曲普坦血浆浓度，最大血浆浓度低于曲普坦注射剂。
在 NP101 贴片的一项随机、双盲、III 期研究中被诊断患有偏头痛的患者，在这项开放标签试验中，他们可以选择在长达 12 个月的时间内使用 NP101 贴片治疗中度或重度头痛的偏头痛发作。
183 名患者使用了 2089 个研究贴片。最常见的不良事件与贴片应用部位有关（45%的患者）。报告发生率超过 2%的唯一非贴片应用部位不良事件是恶心（n=6，3.3%）、上呼吸道感染（n=6，3.3%）和鼻咽炎（n=4，2.2%）。曲坦相关不良事件的发生率为 1.6%。在所有研究者评估的就诊中，大多数患者（从第 1 个月的 74.7%到第 9 个月的 92.2%）在贴片应用部位的评分均为无红斑。对于患者评估，在贴片激活后 24 小时，无或仅有轻微红斑的贴片放置部位百分比为 65.4%。在整个 12 个月的研究中，在所有贴片治疗后 2 小时，23.8%的初始急性偏头痛发作被评为无头痛疼痛，58.2%的发作被评为头痛缓解，78.9%的发作无恶心，60.1%的发作无恐声，53.4%的发作无畏光，20.7%的发作无偏头痛。在 12 个月的研究期间，未观察到耐受性或疗效下降的迹象。
NP101 是一种曲坦透皮制剂，正在开发用于偏头痛的急性治疗，在这项临床试验中，在 12 个月的连续使用中表现出了耐受性和疗效。
