ST LOUIS (MD Consult) - On July 16, 2009, Zogenix, Inc, announced that it has received US Food and Drug Administration (FDA) approval for Sumavel DosePro (sumatriptan injection) needle-free delivery system. This new product is indicated for the treatment of cluster headaches and acute migraines—with or without aura.

 

The Sumavel DosePro system provides for needle-free delivery of subcutaneous sumatriptan. The product is intended for self-administration and consists of a single-dose, prefilled, drug delivery vehicle for liquid sumatriptan. According to the manufacturer's press release, pain relief from migraines in some patients can occur within as little as 10 minutes of drug administration.

 

The FDA approval of Sumavel DosePro was granted on the basis of efficacy and safety data from original filings of studies that used needle-based injections of sumatriptan (ie, Imitrex). In addition, Zogenix conducted clinical studies on bioequivalence, usability, and safety specific to the Sumavel DosePro needle-free delivery system.

 

Sumavel DosePro should only be prescribed when a clear diagnosis of migraine or cluster headache has been established. The product is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. For a given attack, if a patient does not respond to the first dose of Sumavel DosePro, the diagnosis of migraine or cluster headache should be reconsidered before administration of a second dose.

 

The most common adverse events observed in controlled clinical trials using injectable sumatriptan were injection-site reactions, atypical sensations (eg, feelings of tingling, and warm/hot sensations), dizziness, and flushing. The duration of most adverse effects was brief. In clinical trials comparing the safety and tolerability of Sumavel DosePro with sumatriptan injections, most injection-site reactions resolved spontaneously, with no apparent difference noted between Sumavel DosePro and needle-based sumatriptan delivery.

 

Sumavel DosePro is contraindicated in patients with established ischemic heart disease and in patients with symptoms consistent with ischemic heart disease. The product should not be administered to patients with cerebrovascular syndromes, peripheral vascular disease, or uncontrolled hypertension. Very rarely, serious cardiac adverse events have been reported in persons taking sumatriptan, some of whom showed no prior evidence of cardiac disease.

 

Sumavel DosePro should not be administered within 24 hours of other ergotamine-containing or ergot-type medications, or with other 5-HT1 agonists. Furthermore, the product is not generally recommended for use with selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, or monamine oxidase inhibitors. Sumavel DosePro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

圣路易斯(MD Consult)——2009年7月16日，Zogenix公司宣布，已收到美国食品药品管理局(FDA)对Sumavel DosePro(舒马曲坦注射液)无针给药系统的批准令。该新产品适用于治疗丛集性头痛和急性偏头痛——无论是否有先兆。

Sumavel DosePro系统可实现舒马曲坦无针皮下给药。该产品适用于自身给药，由一个预先注满单剂舒马曲坦注射液的给药装置构成。生产厂商在新闻发布会上宣称，一些患者在给药后10分钟内偏头痛即可得到缓解。

FDA批准Sumavel DosePro是基于其疗效和安全性数据，这些数据来源于使用舒马曲坦(即Imitrex)有针注射法相关的原始研究档案。另外，Zogenix公司还特异性针对Sumavel DosePro无针给药系统的生物等效性、可用性和安全性进行了临床研究。

医生应在患者确诊为偏头痛或丛集性头痛的前提下开Sumavel DosePro处方。该产品不适合用作偏头痛的预防疗法或用于控制偏瘫型或基底动脉型偏头痛。若患者某次偏头痛发作对首剂Sumavel DosePro无效，则在使用下一剂之前应重新审视偏头痛或丛集性头痛的诊断结果。

在对照临床试验中，应用舒马曲坦注射液观察到的最常见不良事件为，注射部位反应，感觉异常(如麻刺感，暖/热感觉)，头晕以及面部潮红。大多数不良反应的发作时程较短。在比较Sumavel DosePro与舒马曲坦注射液的安全性和耐受性的临床试验中，大多数注射部位的反应自行消退，Sumavel DosePro与舒马曲坦有针给药法之间未见明显差异。

Sumavel DosePro禁忌证为确诊为缺血性心脏病的患者，以及症状与缺血性心脏病一致的患者。该产品不可用于患有脑血管综合征、外周血管疾病或高血压未得到控制的患者。服用舒马曲坦的患者中报告发生严重心脏不良事件的情况极少，其中有些患者无任何心脏病发作的前兆。

在应用其他含麦角胺或麦角类药物、或者其他5-HT1激动剂治疗的24h内，不得应用Sumavel DosePro。此外，通常不建议将该产品与选择性五羟色胺再摄取抑制剂、五羟色胺-去甲肾上腺素再摄取抑制剂或单胺氧化酶抑制剂一同应用。对于妊娠患者，只有在权衡潜在获益与对胎儿的潜在风险后认为值得冒险时，方可应用Sumavel DosePro。