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            Purdue止痛藥三期臨床研究成功準備提交FDA審核
            2014-03-16         

             

            Purdue止痛藥三期臨床研究成功準備提交FDA審核

            2014年3月13日訊 /生物谷BIOON/ --最近FDA決定冒著專家委員會投票反對的風險批準Zogenix公司的重酒石酸氫可酮類止痛藥Zohydro上市引起了業界的廣泛關注。因為這種藥物具有一定的成癮性,容易造成藥物濫用。一些分析人士甚至不客氣的批評FDA,稱這將造成又一個藥物濫用的典型案例。與此同時,Zogenix公司的老對手Purdue公司最近宣布公司研發的同類非成癮止痛藥物臨床三期研究已經完成,將于今年晚些時候提交FDA審查,這也或將使Zogenix公司的Zohydro上市前景蒙上一層陰影。

            Purdue公司開發的新藥臨床三期研究結果顯示,大部分患者的疼痛情況減輕了30%以上,而48%的患者病痛緩和程度達到了50%以上。公司代表認為,淘汰成癮性止痛藥是未來止痛藥市場的必然趨勢之一,現在的技術水平完全能夠達到這一要求。(生物谷Bioon.com)

            詳細英文報道:

            As the commercial release of Zogenix's hydrocodone bitartrate pain drug Zohydro spawns headlines from coast-to-coast warning of a potential epidemic of abuse similar to what was seen with OxyContin, the rival Purdue Pharma says it has successfully wrapped a Phase III trial of its abuse-resistant competitor. And the data sets the stage for an FDA filing later this year as Zogenix ($ZGNX) labors at its own early-stage efforts at making a pain pill that's harder to abuse.

            The FDA triggered a firestorm of controversy recently when officials decided to ignore a lopsided expert panel vote against Zohydro--largely because of its potential for being abused by addicts looking for a quick high by crushing, snorting and injecting the painkillers--and approved the pain drug for marketing. Consumer groups, influential politicians and physicians swiftly moved in on the attack, saying that the FDA had set up another scenario for drug abuse that was likely to be felt in every city and town in the U.S.

            "It's the perfect drug of abuse for drug users," one doctor in Orange County warned CBS, as media groups around the country seized on the issue. And there's no sign that the controversy will end anytime soon--unless a competitor drug like this comes along.

            Over at Bloomberg, writer Drew Armstrong notes that FDA pain drug czar Bob Rappaport has already said the agency would consider jerking Zohydro from the market if an abuse-resistant version become available.

            That would make Purdue very happy.

            "We firmly believe that the market must move to all abuse-deterrent formulations," Purdue R&D chief Gary Stiles told Bloomberg. "There's not a technical reason why we and others can't do that." Purdue originally developed and sold Oxy, which started the whole controversy.

            Zogenix's investors didn't miss the implications of Purdue's advance today. The biotech's stock, which has been on the rise, is down 17% Wednesday morning.

            But before Zogenix's new marketing effort is damaged, Purdue has to win an approval.

            According to Stamford, CT-based Purdue, investigators determined that the majority of patients treated with once-daily hydrocodone bitartrate "experienced at least a 30% improvement in pain intensity. Nearly half of patients (48%) achieved a 50% improvement with hydrocodone bitartrate. The most common adverse events (≥5%) reported by patients treated with the once-daily agent were constipation, nausea, vomiting, dizziness and headache, which are typically associated with opioid analgesics."

             

             

            關鍵詞:Purdue,Zogenix,止痛藥

            信息來源:生物谷

             


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