台北科技大學 生醫材料工程跨領域研發中心

美國FDA / 藥技中心 林素玲譯 2009/11/18

美國食品藥物管理局(he Food and Drug Administration, FDA)在11月16日核准由Germany的Lohmann Therapie-Systems AD的Andernach與在San Mateo, Calif的NeurogesX Inc共同製造的Qutenza (capsaicin) 8%貼片上市，Qutenza貼片是第一個含capsaicin用於治療帶狀皰疹後神經痛引起神經痛的處方藥。
帶狀皰疹是由濾過性病毒引起的一種感染症，在皮膚上會產生皮疹或水泡，並產生神經性疼痛，患者涵蓋任何年齡層。這種病毒具神經親和性，水痘治癒後，仍以非活化性的狀態，長期潛伏於神經細胞內，當宿主免疫力低時再活化性，而引起帶狀疹。原則上得過帶狀皰疹的病人可終身免疫，但長期用類固醇的病人或淋巴腺腫瘤及白血病等免疫異常的病態可能重覆發生。

Qutenza含capsaicin，這個化合物是從辣椒中發現。市面上雖已有低劑量用於治療疼痛的capsaicin產品，但Qutenza是第一個經由粹取、濃縮、合成經FDA審核程序的處方藥。

FDA藥品評價與研究中心(Center for Drug Evaluation and Research)麻醉、鎮痛和風濕病學產品主任Bob Rappaport博士說，該產品能有效的緩解患者的神經性疼痛。


原文如下
FDA Approves New Drug Treatment for Long-Term Pain Relief after Shingles Attacks

The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles.

Shingles is an outbreak of rash or blisters on the skin that is caused by the same virus that causes chickenpox — the varicella-zoster virus. Anyone who once had chickenpox is at risk of shingles since the virus may become reactivated years after the initial infection. PHN is a condition affecting nerve fibers and the skin that can cause excruciating pain for weeks, months or even years. About 10 to 15 percent of patients who have shingles experience PHN and the complication is even more common in elderly patients.

Qutenza contains capsaicin, a compound found in chili peppers. Although there are over-the-counter products with lower concentrations of capsaicin that are marketed for the treatment of PHN, Qutenza is the first pure, concentrated, synthetic capsaicin-containing prescription drug to undergo FDA review . It was approved on Nov. 16.

“This new product can provide effective pain relief for patients who suffer from PHN,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

The most frequently reported adverse drug reactions included pain, swelling, itching, redness, and bumps at the application site.

Qutenza must be applied to the skin by a health care professional since placement of the patch can be quite painful, requiring use of a local topical anesthetic, as well as additional pain relief such as ice or use of opioid pain relievers. The patient must also be monitored for at least one hour since there is a risk of a significant rise in blood pressure following patch placement.

The patch is manufactured by Lohmann Therapie-Systems AD of Andernach, Germany and distributed by NeurogesX Inc. of San Mateo, Calif.