Sunovion Drug Gets FDA Nod for Treating Parkinson’s “Off” Episodes

Sunovion 药物获得 FDA 批准治疗帕金森“停药”事件

2020-05-22 13:30:17 Xconomy

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May 21st, 2020 Xconomy Boston —  The FDA on Thursday approved a Sunovion Pharmaceuticals treatment for Parkinson’s disease, giving patients a new way to take an old drug. The Sunovion product, Kynmobi, is a formulation of apomorphine hydrochloride, a drug that treats “off” episodes experienced by Parkinson’s patients. These are times when the standard of care drug, levodopa, wears off and tremors, stiffness, and other symptoms return. Apomorphine can be administered in several different ways. The Sunovion product is the first sublingual formulation of apomorphine approved by the FDA. The FDA decision for Kynmobi comes 16 months after the FDA rejected Sunovion’s initial application. The Marlborough, MA-based company resubmitted the file last November with more details about the product’s packaging and additional analyses of clinical data. Approval was based on the results of a a Phase 3, placebo-controlled study that enrolled 109 patients. The main goal was to show a change according a rating scale used to assess movement in Parkinson’s patients. According to results published in The Lancet, patients who received the Sunovion drug showed an average reduction of 7.6 points on the scale compared to the average reduction reported for patients given a placebo. The drug also took effect quickly, with initial improvements observed 15 minutes after the oral film was placed under patients’ tongues. The Sunovion film was well tolerated by patients. The most frequent side effects reported in the study were nausea, reactions in the throat, drowsiness, and dizziness. The throat reactions prompted nine, or about 17 percent, of the 54 patients assigned to receive the drug—and one taking a placebo—to drop out of the study. The drug label warns that patients should not use Kynmobi if they are taking a class of drugs called 5HT3 antagonists to treat nausea. These drugs, in combination with apomorphine, can lead to low blood pressure and loss of consciousness. Kynmobi is expected to compete against other products that also treat off episodes in Parkinson’s. Acorda Pharmaceuticals (NASDAQ: ACOR) markets Inbrija, an inhaled version of levodopa. US WorldMeds sells Apokyn, an injection pen that administers apomorphine. The company also sells a safinamide (Xadago) tablet to treat off episodes. Last month, Supernus Pharmaceuticals (NASDAQ: SUPN) announced it was acquiring the entire US WorldMeds central nervous system drug portfolio to add Parkinson’s disease products to its lineup. Sunovion says it expects Kynmobi will be available in pharmacies in September. Photo by Business Wire Frank Vinluan is an Xconomy editor based in Research Triangle Park. You can reach him at fvinluan@xconomy.com. Follow @frankvinluan
2020年5月21日 锥形经济 波士顿-- FDA 周四批准了 Sunovion 药物治疗帕金森病,为患者提供了一种新的服用旧药物的方法。 Sunovion 产品 Kynmobi 是一种盐酸阿扑吗啡的制剂,这种药物可以治疗帕金森患者经历的“断断续续”发作。这些时候的标准护理药物,左旋多巴,疲劳和震颤,僵硬,和其他症状返回。吗啡可以用几种不同的方式给药.Sunovion 产品是首个获得 FDA 批准的阿扑吗啡舌下制剂。 FDA 对 Kynmobi 的决定是在16个月前, FDA 拒绝了 Sunovion 的最初申请。位于马萨诸塞州万宝路的公司去年11月重新提交了该文件,提供了该产品包装的更多细节和临床数据的额外分析。 批准的依据是一项第3期安慰剂对照研究的结果,该研究纳入了109名患者。主要目标是根据用于评估帕金森患者运动的评定量表显示出变化。根据《柳叶刀》上发表的研究结果,接受 Sunovion 药物治疗的患者与接受安慰剂治疗的患者相比,平均减小了7.6个百分点。该药物也迅速生效,在口膜置于病人舌头下15分钟后观察到初步改善。 患者对 Sunovion 薄膜有很好的耐受性。研究中最常见的副作用是恶心、喉咙反应、嗜睡和头晕。喉部反应促使54名接受该药的患者中有9名(约17%)放弃这项研究,其中一名服用安慰剂。该药物标签警告说,如果患者服用一种名为5HT3拮抗剂的药物治疗恶心,他们不应该使用 Kynmobi 。这些药物与吗啡联合使用可导致低血压和意识丧失。 预计 Kynmobi 将与其他治疗帕金森氏症的药物竞争。Acorda Pharmaceuticals ( NASDAQ : ACOR )市场 Inbrija ,一种吸入式左旋多巴.美国世界医学公司出售 Apokyn ,一种管理 Apo吗啡的注射笔。该公司还销售了一款治疗间歇性发作的 safinamide ( Xadago )平板电脑。上个月, Supernus Pharmaceuticals ( NASDAQ : SUN )宣布将收购美国 WorldMed 的整个中枢神经系统药物组合,将帕金森病产品纳入其产品阵容。 Sunovion 表示,它预计 Kynmobi 将于9月在药店上市。 商业电线摄影 Frank Vinluan 是一个 Xconeconomy 的编辑基于研究三角公园。你可以到 fvinluan @ xconomi.com 联系他。

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