NeurogesX宣布，获得美国FDA批准销售Qutenza(TM) (capsaicin) 8%贴片，为第一种与唯一包含处方药强度的capsaicin，治疗带状疱疹後神经痛引起的神经痛

Indication

Qutenza^TM is indicated for the management of neuropathic pain associated with postherpetic neuralgia.

About Qutenza^TM (capsaicin) 8% patch

Qutenza^TM contains capsaicin in a local dermal delivery system. The capsaicin in Qutenza^TM is a synthetic equivalent of the naturally occurring compound found in chili peppers.

Important Safety Information

Qutenza^TM is administered by a physician or a health professional under the close supervision of a physician. Qutenza^TM may be administered every 3 months or as warranted by the return of pain, but not more frequently than every 3 months. In clinical trials, the most common adverse reactions were application site redness, pain, itching, and papules. The majority of these reactions were transient and self limited. Among patients treated with Qutenza^TM, 1% discontinued prematurely due to an adverse event. Serious adverse reactions included application-site pain and increased blood pressure. Blood pressure increases during or shortly after Qutenza^TM treatment were on average less than 10 mm Hg, although some patients had greater increases and these changes lasted for approximately 2 hours after patch removal.

Qutenza(TM) (capsaicin) 8%贴片说明书

A single 1-hour localized treatment can provide up to 3 months of post-shingles pain reduction

The U.S. Food and Drug Administration (FDA) has approved Qutenza^TM (capsaicin) 8% patch for the management of pain due to postherpetic neuralgia (PHN) – a chronic painful condition that develops in certain patients following a herpes zoster (shingles) outbreak.

外周神经源性疼痛贴片Qutenza将进入欧洲市场

美国NeurogesX生物制药公司表示，欧盟委员会已批准其179毫克Qutenza表皮贴片进入当地市场，该药用于治疗非糖尿病导致的外周神经源性疼痛。NeurogesX致力于研发和生产疼痛治疗药物。

　去年10月份，NeurogesX也向FDA递交了Qutenza的上市申请。这次该药在欧洲获准后，它可进入欧盟27个成员国进行销售。

　这次Qutenza在欧洲获准得益于2009年3月19日欧洲药监局人用医疗产品委员会对药物的肯定。NeurogesX计划通过在欧洲寻找一家合作伙伴在当地销售这种产品。

　NeurogesX总裁表示，这次Qutenza获准进入欧洲市场对该公司具有里程碑意义，希望可以在接下来的几个月内找到欧洲经销商，并于明年早期开始把药物推进当地市场。

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