Cady Roger K, McAllister Peter J, Spierings Egilius L H, Messina John, Carothers Jennifer, Djupesland Per G, Mahmoud Ramy A
Headache Care Center, Springfield, MO, USA.
Headache. 2015 Jan;55(1):88-100. doi: 10.1111/head.12472. Epub 2014 Oct 30.
To evaluate the efficacy and safety of AVP-825, a drug-device combination of low-dose sumatriptan powder (22 mg loaded dose) delivered intranasally through a targeted Breath Powered device vs an identical device containing lactose powder (placebo device) in the treatment of migraine headache.
Early treatment of migraine headaches is associated with improved outcome, but medication absorption after oral delivery may be delayed in migraineurs because of reduced gastric motility. Sumatriptan powder administered with an innovative, closed-palate, Bi-Directional, Breath Powered intranasal delivery mechanism is efficiently absorbed across the nasal mucosa and produces fast absorption into the circulation. Results from a previously conducted placebo-controlled study of AVP-825 showed a high degree of headache relief with an early onset of action (eg, 74% AVP-825 vs 38% placebo device at 1 hour, P<.01).
In this double-blind, placebo-controlled, parallel-group study in adults with a history of migraine with or without aura, participants were randomized via computer-generated lists to AVP-825 or placebo device to treat a single migraine headache of moderate or severe intensity. The primary endpoint was headache relief (defined as reduction of headache pain intensity from severe or moderate migraine headache to mild or none) at 2 hours post-dose.
Two hundred and thirty patients (116 AVP-825 and 114 placebo device) were randomized, of whom 223 (112 and 111, respectively) experienced a qualifying migraine headache (their next migraine headache that reached moderate or severe intensity). A significantly greater proportion of AVP-825 patients reported headache relief at 2 hours post-dose compared with those using the placebo device (68% vs 45%, P=.002, odds ratio 2.53, 95% confidence interval [1.45, 4.42]). Between-group differences in headache relief were evident as early as 15 minutes, reached statistical significance at 30 minutes post-dose (42% vs 27%, P=.03), and were sustained at 24 hours (44% vs 24%, P=.002) and 48 hours (34% vs 20%, P=.01). Thirty-four percent of patients treated with AVP-825 were pain-free at 2 hours compared with 17% using the placebo device (P=.008). More AVP-825 patients reported meaningful pain relief (patient interpretation) of migraine within 2 hours of treatment vs placebo device (70% vs 45%, P<.001), and fewer required rescue medication (37% vs 52%, P=.02). Total migraine freedom (patients with no headache, nausea, phonophobia, photophobia, or vomiting) reached significance following treatment with AVP-825 at 1 hour (19% vs 9%; P=.04). There were no serious adverse events (AEs), and no systemic AEs occurred in more than one patient. Chest pain or pressure was not reported, and only one patient taking AVP-825 reported mild paresthesia. No other triptan sensations were reported.
Targeted delivery of a low-dose of sumatriptan powder via a novel, closed-palate, Breath Powered, intranasal device (AVP-825) provided fast relief of moderate or severe migraine headache in adults that reached statistical significance over placebo by 30 minutes. The treatment was well tolerated with a low incidence of systemic AEs.
评估AVP - 825（一种通过靶向呼吸驱动装置经鼻内递送低剂量舒马曲坦粉末（负荷剂量22毫克）的药物装置组合）与含乳糖粉末的相同装置（安慰剂装置）相比，在治疗偏头痛方面的疗效和安全性。
偏头痛的早期治疗与改善预后相关，但由于胃动力降低，偏头痛患者口服给药后的药物吸收可能会延迟。采用创新的、封闭腭部的、双向、呼吸驱动的鼻内给药机制施用舒马曲坦粉末可有效跨鼻黏膜吸收，并快速吸收进入循环。先前进行的AVP - 825安慰剂对照研究结果显示，起效早，头痛缓解程度高（例如，1小时时AVP - 825组为74%，安慰剂装置组为38%，P<0.01）。
在这项针对有或无先兆偏头痛病史的成年人的双盲、安慰剂对照、平行组研究中，通过计算机生成的列表将参与者随机分为AVP - 825组或安慰剂装置组，以治疗单次中度或重度强度的偏头痛。主要终点是给药后2小时的头痛缓解（定义为头痛疼痛强度从中度或重度偏头痛降至轻度或无疼痛）。
230名患者（116名使用AVP - 825，114名使用安慰剂装置）被随机分组，其中223名（分别为112名和111名）经历了符合条件的偏头痛（他们下一次达到中度或重度强度的偏头痛）。与使用安慰剂装置的患者相比，AVP - 825组在给药后2小时报告头痛缓解的患者比例显著更高（68%对45%，P = 0.002，优势比2.53，95%置信区间[1.45, 4.42]）。头痛缓解的组间差异早在15分钟时就很明显，在给药后30分钟达到统计学显著性（42%对27%，P = 0.03），并在24小时（44%对24%，P = 0.002）和48小时（34%对20%，P = 0.01）时持续存在。与使用安慰剂装置的患者相比，接受AVP - 825治疗的患者在2小时时无疼痛的比例为34%，而使用安慰剂装置的患者为17%（P = 0.008）。与安慰剂装置相比，更多接受AVP - 825治疗的患者在治疗后2小时内报告偏头痛有有意义的疼痛缓解（患者自我判断）（70%对45%，P<0.001），并且需要急救药物的患者更少（37%对52%，P = 0.02）。治疗1小时后，AVP - 825组的完全无偏头痛（无头痛、恶心、恐声症、畏光症或呕吐的患者）达到显著性（19%对9%；P = 0.04）。没有严重不良事件（AE），并且没有全身性AE发生在超过一名患者中。未报告胸痛或压迫感，只有一名服用AVP - 825的患者报告有轻度感觉异常。未报告其他曲坦类药物相关的感觉。
通过一种新型的、封闭腭部的、呼吸驱动的鼻内装置（AVP - 825）靶向递送低剂量舒马曲坦粉末，可使成年人中度或重度偏头痛头痛快速缓解，在30分钟时与安慰剂相比具有统计学显著性。该治疗耐受性良好，全身性AE的发生率较低。
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