2014年9月17日訊 /生物谷BIOON/ --美國FDA最近批准了由阿斯利康公司和Nektar生物醫藥公司聯合開發的新型阿片類療法naloxegol進入美國市場。這一藥物是一種口服阿片類受體抑制劑，能夠在有效治療便秘的同時，最大程度降低了傳統阿片類藥物可能引起的腸胃方面的副作用。在阿斯利康和Nektar公司進行的1352名患者參加的臨床研究中，相對於其他同類藥物，這種藥物能夠有效促進大腸蠕動，從而治療便秘。
不過，仍然值得注意的是，與其他類似藥物相似，服用這一藥物的患者仍有心臟病發作增加的風險。不過，FDA的評審專家最終決定對naloxegol亮起綠燈顯然也對naloxegol的這一"瑕疵"有了充分把握。同時，阿斯利康和Nektar公司為了最大限度的將這一副作用風險納入控制範圍，雙方將在藥物上市後開展一項大規模的市場調查，以確定評估這一藥物對患者心血管疾病的影響。
Naloxegol將以Movantik的商品名上市。兩家公司都對這一產品充滿了信心，預計這一藥物將為他們帶來豐厚的回報。Naloxegol首先由Nektar公司發現並開發，2009年阿斯利康公司與Nektar公司籤訂了一項價值15億美元的研發協議，分享了這一藥物。
另一方面，作為阿斯利康公司和Nektar公司的主要競爭對手，Salix Pharmaceuticals公司開發的類似產品Relistor在遭遇2012年的挫折後，也將於最近再次提交給FDA審核。鑑於FDA對此類藥物的態度轉變，Salix公司將有很大希望也獲得批准。不過即使沒有Relistor，阿斯利康公司和Nektar公司也很難獨霸這一市場。Sucampo Pharmaceuticals的Amitiza已經在去年上市，而Cubist Pharmaceuticals公司治療便秘藥物也將很快提交FDA審核。（生物谷Bioon.com）
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詳細英文報導：
The FDA approved a new opioid-induced constipation treatment from partners AstraZeneca ($AZN) and Nektar Therapeutics ($NKTR), shaking off some safety concerns and green-lighting a drug the two hope can bring in billions.
The treatment, naloxegol, is an oral blocker of mu-opioid receptors, designed to ease the gastrological side effects associated with common painkillers. In AstraZeneca and Nektar's 1,352-patient pivotal program, the drug proved itself effective in increasing the number of bowel movements among opioid-taking subjects reporting constipation, significantly beating out placebo.
But, like other drugs in its class, naloxegol has been linked to an increased risk of heart attacks, and while the agency didn't let that stand in the way of approval, regulators are asking AstraZeneca and Nektar to conduct a large post-market study to keep an eye on any flare-ups in cardiovascular events.
Now the two companies are gearing up to market their treatment as Movantik, eyeing a space AstraZeneca believes could make the drug a blockbuster. The treatment, discovered by Nektar, is the first mu-opioid treatment approved for OIC. AstraZeneca stepped in on the program in 2009, signing a deal worth up to $1.5 billion and touting the drug as a meaningful advance in an area of unmet medical need.
With the approval, the partners leapfrog rival Salix Pharmaceuticals ($SLXP), whose mu-opioid-blocking Relistor endured an FDA rejection for OIC in 2012 over cardiovascular concerns. That drug is up for a second chance this month, and, in light of naloxegol's approval and a change in tone at the agency, analysts have come to like its odds.
But AstraZeneca and Nektar will hardly have sole claim on the market. Even without Relistor providing competition, Sucampo Pharmaceuticals ($SCMP) markets Amitiza, a chloride channel activator approved last year, and Cubist Pharmaceuticals ($CBST) sells a mu-opioid receptor antagonist of its own in Entereg, though that drug is yet to receive an OIC nod.