2014年9月16日美国食品药品监督管理局(FDA)批准阿斯利康公司和Nektar生物医药公司联合开发的naloxegol(商品名:Movantik)用于治疗阿片镇痛药所引起的便秘。

Movantik(naloxegol)属于一类药物被称为周边作用阿片受体拮抗剂，被用于减低阿片类药物的便秘作用。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。

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 (lubiprostone)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。

FDA Approves Movantik (naloxegol) for Opioid-Induced Constipation

On September 16, 2014, the US Food and Drug Administration (FDA) approved naloxegol (trade name:Movantik, AstraZeneca Pharmaceuticals/Nektar Therapeutics) as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain.

Millions of patients take opioids for relief from chronic pain, but one undesirable side effect of opioids is that they bind to mu-receptors in the gastrointestinal tract and can lead to constipation.

San Francisco-based Nektar Therapeutics developed the drug and licensed it to AstraZeneca in September 2009 for $125million.

Movantik (naloxegol),discovered by San Francisco-based Nektar Therapeutics, is the first mu-opioid treatment approved for opioid-induced constipation (OIC). Nektar licensed the drug to AstraZeneca in September 2009 in a deal worth up to $1.5 billion.

Rival Salix Pharmaceuticals, 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.

Last year, the FDA approved lubiprostone (Amitiza, Sucampo Pharmaceuticals Inc/Takeda Pharmaceuticals USA Inc), the first oral treatment for OIC in adults with chronic noncancer pain. The drug is a specific activator of CIC-2 chloride channels in the intestinal epithelium and bypasses the antisecretory action of opiates by activation of apical CIC-2 channels.

Naloxegol is also under regulatory review by the European Medicines Agency (EMA).

Movantik
成分：ナロキセゴール (Naloxegol)
承認日：2014年9月16日
製造販売元: アストラゼネカ
適応：オピオイド誘発性便秘