咔唑网9月17日消息：
美国FDA最近批准了由阿斯利康公司和Nektar生物医药公司联合开发的新型*片鸦**类疗法naloxegol进入美国市场。这一药物是一种口服*片鸦**类受体*制剂抑**，能够在有效治疗便秘的同时，最大程度降低了传统*片鸦**类药物可能引起的肠胃方面的副作用。在阿斯利康和Nektar公司进行的1352名患者参加的临床研究中，相对于其他同类药物，这种药物能够有效促进大肠蠕动，从而治疗便秘。
不过，仍然值得注意的是，与其他类似药物相似，服用这一药物的患者仍有心脏病发作增加的风险。不过，FDA的评审专家最终决定对naloxegol亮起绿灯显然也对naloxegol的这一"瑕疵"有了充分把握。同时，阿斯利康和Nektar公司为了最大限度的将这一副作用风险纳入控制范围，双方将在药物上市后开展一项大规模的市场调查，以确定评估这一药物对患者心血管疾病的影响。
Naloxegol将以Movantik的商品名上市。两家公司都对这一产品充满了信心，预计这一药物将为他们带来丰厚的回报。Naloxegol首先由Nektar公司发现并开发，2009年阿斯利康公司与Nektar公司签订了一项价值15亿美元的研发协议，分享了这一药物。
另一方面，作为阿斯利康公司和Nektar公司的主要竞争对手，Salix Pharmaceuticals公司开发的类似产品Relistor在遭遇2012年的挫折后，也将于最近再次提交给FDA审核。鉴于FDA对此类药物的态度转变，Salix公司将有很大希望也获得批准。不过即使没有Relistor，阿斯利康公司和Nektar公司也很难独霸这一市场。Sucampo Pharmaceuticals的Amitiza已经在去年上市，而Cubist Pharmaceuticals公司治疗便秘药物也将很快提交FDA审核。（生物谷Bioon.com）
详细英文报道：
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.
【原标题：阿斯利康公司研究出治疗便秘药物 口服*片鸦**类药物】