ST LOUIS (MD Consult) - On November 16, 2009, NeurogesX announced that the US Food and Drug Administration has approved Qutenza (capsaicin) 8% patch for the management of neuropathic pain attributed to postherpetic neuralgia (PHN) that may occur after an episode of herpes zoster (shingles). The Qutenza patch releases a synthetic form of capsaicin, a substance in chili peppers that gives them their heat sensation, through a dermal delivery system.

A press release by NeurogesX states that clinical studies have shown that PHN pain can be reduced for up to 12 weeks after a single 1-hour application of Qutenza. Up to 4 patches may be used, and patches may be cut to conform to the size and shape of the painful area. Treatment with Qutenza may be repeated every 3 or more months as warranted by the return of pain.

In clinical trials, the most common adverse reactions associated with Qutenza were application-site redness, pain, itching, and papules. The majority of these reactions were transient and self limited. Among patients receiving Qutenza, 1% discontinued treatment prematurely as a result of an adverse event. Serious adverse reactions included application-site pain and increased blood pressure. Increases in blood pressure occurred during or shortly after exposure to Qutenza. The changes were on average &60;10 mm Hg, though some patients experienced greater increases. Blood pressure changes were apparent for approximately 2 hours after patch removal.

Neurogesx plans to launch Qutenza in the United States in the first half of 2010.

圣路易斯(MD Consult)——2009年11月16日，NeurogesX公司宣布，美国食品药品管理局(FDA)已批准Qutenza(辣椒素) 8%贴剂用于治疗带状疱疹后神经痛(PHN)，该疼痛可出现于带状疱疹发作后。Qutenza贴剂可释放出一种合成型辣椒素，即红辣椒中的一种物质，可通过皮肤吸收系统产生热觉。

NeurogesX 公司在新闻发布会上声明，临床研究已显示，疼痛部位贴上Qutenza仅1h后PHN疼痛即可减少，效力能持续达12周。可以使用达4贴，并可根据疼痛区域的大小和形状对贴片进行相应的剪切。Qutenza贴剂治疗可以每3个月或3个月以上重复一次，这视疼痛的复发时间而定。

 

在临床试验中，Qutenza最常见的不良反应为用药部位发红、疼痛、发痒以及丘疹。其中大多数不良反应呈暂时性和自限性。在接受Qutenza治疗的患者中，有1%因不良反应而提前终止治疗。严重的不良反应包括用药部位疼痛和血压升高。血压升高发生于应用Qutenza过程中或接触此贴剂后不久。某些患者的血压出现较大幅度的上升，但平均变化值为60;10 mmHg。在去除贴剂后血压变化持续约2 h。

 

Neurogesx公司拟于2010年上半年将Qutenza推向美国市场。