作者：Susan Jeffrey 齣處：WebMD醫學新聞 　　November 25 2008 — 美國食品藥物管理局（FDA）宣布核準tapentadol hydrochloride（John FDA核準Tapentadol用於中重度疼痛 - 趣味新聞網

發表日期 2008-12-08T23:54:59+08:00

     作者：Susan Jeffrey
齣處：WebMD醫學新聞

November 25, 2008 — 美國食品藥物管理局（FDA）宣布核準tapentadol hydrochloride（Johnson & Johnson藥廠）用於緩解中重度急性疼痛；Tapentadol是一個立即釋放口服錠劑。

這個藥物的商品名還沒有確認，是個作用於中樞神經係統的止痛藥物，有50、75與100 mg的劑型。

FDA藥物評估與研究中心新藥辦公室的主任John Jenkins醫師在FDA的聲明稿中錶示，這項核準案提供健康照護專業人員一個治療中重度疼痛的選擇。

FDA的聲明稿中指齣，這個藥物本身屬於鴉片類藥物，但也被分類為非鴉片藥物；該藥物主要作為mu鴉片受體緻效劑，但也會抑製正腎上腺素的再迴收，這緻使它可能具有止痛的作用。

在FDA核準案之後，一項來自Johnson & Johnson藥廠的聲明指齣，就如同每個接受聯邦規範的管控藥物，tapentadol將會接受美國緝毒管理局的安排，這個藥物直到接受分類後纔能夠上市。

FDA的聲明稿中附帶錶示，鴉片類藥物被認為是安全的，且對於特定病患來說是有效的，但這會造成依賴性、濫用以及成癮的問題。所有接受鴉片類藥物治療的病患，都應該由他們的健康照護專業人員監測是否有濫用的病徵。

Johnson & Johnson藥廠錶示，這項核準案是根據牽涉到2,100位病患的臨床研究結果，這些第三期臨床研究，發錶在第27屆美國疼痛醫學會的年會中，這個於今年5月舉辦的年會，其結果顯示，相較於接受安慰劑的病患，這些接受囊炎切除的病患，使用這個藥物的疼痛緩解程度顯著較佳，囊炎切除是個很常見的腳部手術。不但如此，在其他研究中，末期關節疾病、以及下背痛、或是髖骨或膝蓋骨關節炎，都有類似結果。同時，一般來說這個藥物的耐受性良好。

FDA的聲明指齣，tapentadol最常見的不良反應是惡心、頭暈、嘔吐、嗜睡與頭痛；Tapentadol的仿單包括對呼吸抑製的警告；當與其他鴉片類藥物、毒品或喝酒時，對中樞神經加成性的抑製作用；以及被濫用的可能。

在他們的聲明中，該公司也錶示，這個新藥不適閤使用於任何不適用mu受體鴉片類藥物的病患，例如曾經有嚴重呼吸抑製、急性或是嚴重支氣管氣喘、或是二氧化碳血癥；有腸絞痛的病患；或是那些目前正在使用或過去14天內曾經使用單胺氧化酶抑製劑（MAOIs）的病患。這個藥物應該小心使用於有癲癇病史或是任何將使病患暴露在癲癇發作風險下的狀況。

最後，Johnson & Johnson藥廠錶示，使用tapentadol可能發生潛在有緻命風險的血清素癥候群，特彆是同時併用血清素激性藥物，例如（選擇性血清素再迴收抑製劑）SSRIs、（血清素－正腎上腺素再迴收抑製劑）SNRIs、（三環抗憂鬱藥物）TCAs、MAOIs與triptans，以及其他可能影響血清素代謝的藥物（包括MAOIs）。

Tapentadol由Johnson & Johnson藥廠製造。PriCara，這是Ortho-McNeil-Janssen藥廠的分公司，將會在美國行銷這個藥物。該公司聲明稿中指齣，這兩個公司都是Johnson & Johnson藥廠的子公司。

FDA Approves Tapentadol for Moderate to Severe Acute Pain

By Susan Jeffrey
Medscape Medical News

November 25, 2008 — The US Food and Drug Administration (FDA) has announced approval of tapentadol hydrochloride (Johnson & Johnson), an immediate-release oral tablet for the relief of moderate to severe acute pain.

The drug, for which a trade name has not yet been established, is a centrally acting analgesic that will be available in doses of 50, 75, and 100 mg.

"This approval offers healthcare professionals an additional choice for treating moderate to severe pain," John Jenkins, MD, director of the office of new drugs at the FDA's Center for Drug Evaluation and Research, said in a statement from the FDA.

The drug acts as both an opioid and nonopioid agent, the FDA release notes. It acts primarily as a mu-opioid-receptor agonist but also inhibits reuptake of norepinephrine, which may also have an analgesic effect.

A statement from Johnson & Johnson notes that following this FDA approval, "as per federal regulation for all controlled substances, tapentadol will be reviewed by the US Drug Enforcement Administration for scheduling, and it cannot be sold until it receives a scheduling classification."

"Opioids are considered safe and effective in selected patients but can cause dependence, abuse, and addiction," the FDA release adds. "All patients treated with opioids require careful monitoring by their healthcare professional for signs of abuse."

The approval was based on data from clinical studies involving more than 2100 patients, the Johnson & Johnson release notes. These phase 3 studies, presented at the 27th Annual Scientific Meeting of the American Pain Society in May, showed significant relief compared with placebo for patients undergoing bunionectomy, a common foot surgery; in pain from end-stage joint disease; and with low back pain or osteoarthritis of the hip or knee. It was generally well tolerated.

The most common adverse effects from tapentadol are nausea, dizziness, vomiting, sleepiness, and headaches, the FDA release said. "The labeling for tapentadol includes warnings about the risk of respiratory depression; addictive depressive effects on the central nervous system when taken with alcohol, other opioids, or illicit drugs; and abuse potential," the FDA release adds.

In its statement, the company also notes that the new drug is contraindicated in any situation where mu-opioids are contraindicated, such as in significant respiratory depression, acute or severe bronchial asthma, or hypercapnia; in patients with paralytic ileus; or in those who are currently using or are within 14 days of using monoamine oxidase inhibitors (MAOIs). The drug should be prescribed "with care" in patients with a history of a seizure disorder or any condition that would put the patient at risk for seizures.

Finally, the Johnson & Johnson release points out that a potentially life-threatening serotonin syndrome may occur with tapentadol, "particularly with concomitant use of serotonergic drugs such as [selective serotonin-reuptake inhibitors] SSRIs, [serotonin-norepinephrine-reuptake inhibitors] SNRIs, [tricyclic antidepressants] TCAs, MAOIs, and triptans and with drugs that impair metabolism of serotonin (including MAOIs)."

Tapentadol is manufactured by Johnson & Johnson. PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals, will market tapentadol in the United States. Both are wholly owned subsidiaries of Johnson & Johnson, the company release notes.

[ 本帖最後由 goodcat1111 於 2008-12-15 11:54 編輯 ]

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