FDA批准Lyrica治疗脊髓损伤相关性神经性疼痛

圣路易斯(MD Consult)——2012年6月21日，辉瑞宣布，美国食品药品管理局(FDA)已批准Lyrica(普瑞巴林)用于治疗与脊髓损伤相关的神经性疼痛。根据辉瑞发布的新闻稿，约有33%的脊髓损伤患者报告有严重或痛苦的神经性疼痛。患者可能在受伤2周后就出现脊髓损伤相关性神经性疼痛，并且可持续长达25年。

FDA批准该适应证是基于2项随机、双盲、弹性剂量(150~600 mg/d)、安慰剂对照的3期临床试验数据。这2项研究共招募了357例患者。受试者被允许继续服用其他止痛药物，包括非甾体抗炎药、阿片类和非阿片类药物。其中一项研究招募的是创伤性脊髓损伤患者，另一项研究则同时招募了创伤性和非创伤性(如切除良性脊柱肿瘤，或脊髓缺血性卒中)脊髓损伤。

这2项研究的主要发现是，使用Lyrica可在整个研究期间(分别为12周和16周)显著缓解脊髓损伤相关性神经性疼痛，明显优于安慰剂。此外，接受Lyrica治疗者的疼痛程度分别比安慰剂组患者减轻30%和50%。在部分患者中，Lyrica减轻疼痛的效果从第1周就具有显著性，并贯穿整个试验。

试验中，接受Lyrica治疗者的最常见不良事件为嗜睡、头晕、口干、疲乏和外周水肿。

在美国，Lyrica适用于缓解糖尿病神经痛、带状疱疹后遗神经痛、纤维肌痛、脊髓损伤相关性神经性疼痛，以及服用≥1种抗癫痫药物的成年癫痫患者的部分性癫痫发作。

爱思唯尔  版权所有

ST LOUIS (MD Consult) - On June 21, 2012, Pfizer announced that the US Food and Drug Administration (FDA) has approved Lyrica (pregabalin) for the management of neuropathic pain associated with spinal cord injury. According to a press release by Pfizer, approximately 33% of patients with a spinal cord injury report below-level neuropathic pain that is severe or excruciating. Patients may experience neuropathic pain associated with spinal cord injury as early as 2 weeks after injury and it may persist for up to 25 years.

This FDA approval was granted on the basis of data from 2 randomized, double-blind, flexibly dosed (150-600 mg/d), placebo-controlled, phase 3 trials, which enrolled 357 patients. Patients were allowed to continue taking other pain medications, including nonsteroidal antiinflammatory drugs, opioids, and nonopioids. The population of one study consisted patients who had sustained a traumatic spinal cord injury. The population of the other study consisted of patients who had sustained a traumatic spinal cord injury and patients who had sustained injury to the spinal cord from nontraumatic causes (eg, removal of a benign spinal tumor, or spinal cord ischemic stroke).

The primary finding from these studies was that the use of Lyrica significantly reduced neuropathic pain associated with spinal cord injury from baseline throughout the duration of the studies (12 weeks and 16 weeks, respectively), compared with placebo. In addition, more patients who received Lyrica showed a 30% and 50% reduction in pain than did patients receiving placebo. In some patients, the reduction in pain with Lyrica was significant as early as week 1 and continued throughout the duration of the trials.

The most common adverse events in these trials in patients who received Lyrica were somnolence, dizziness, dry mouth, fatigue, and peripheral edema.

In the United States, Lyrica is indicated for the relief of diabetic nerve pain, post-herpetic neuralgia, fibromyalgia, neuropathic pain associated with spinal cord injury, and partial-onset seizures in adults with epilepsy who take one or more drugs for seizures.