Trevena Sees Path Forward for Rejected Opioid Pain Medicine

阿片类镇痛药物驱动生物制药公司 Trevena 股价飙升

2019-02-01 15:12:55 BioSpace

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Shares of Trevena soared nearly 120 percent in Monday trading after the company announced it has found a path forward for its intravenous opioid-pain reliever oliceridine. The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter to the company in November, one month after an advisory committee rejected the drug. When the FDA issued the CRL, the regulatory agency requested additional clinical data on QT prolongation and indicated that the submitted safety database is not of adequate size for the proposed dosing. The FDA also requested certain additional nonclinical data and validation reports, Trevena said in November. However, on Monday, Pennsylvania-based Trevena said that following a Type A meeting with the FDA, the agency provided hope for a path forward. On Monday, Trevena said it will submit a detailed protocol and analysis plan to the FDA soon and, following feedback, will initiate the required study in the first half of 2019. The FDA agreed that the company’s current safety database will support labeling at a maximum daily dose of 27 mg. Trevena also noted that the FDA requested that the company conduct a study in healthy volunteers to collect the requested QT interval data. The study should include placebo- and positive-control arms, the FDA said. Additional efficacy data was not required. The FDA did request supporting nonclinical data related to the characterization of the 9662 metabolite and the remaining product validation reports when the oliceridine NDA is resubmitted, the company said. Carrie L. Bourdow, president and chief executive officer of Trevena, said the company is encouraged by the meeting results from the FDA and believes this is a path forward for regulatory approval. “We remain committed to our mission of ensuring access to safe and effective treatment options for hospital patients who require an IV opioid to manage their moderate to severe acute pain,” Bourdow said in a statement. Trevena has had issues getting oliceridine across the finish line. Not only did the FDA reject it in 2018, but the company also had issues with the drug following a late-stage analysis in 2017. Following a Phase III study, analysts questioned whether or not the drug could distinguish itself from morphine, particularly in some measures of safety. That resulted in a shakeup at the company that saw about 30 percent of the staff laid off in order to provide funds to support the continued development of the opioid treatment. While the company does have a path forward to potentially see approval of oliceridine, Trevena is the subject of a class action lawsuit. The lawsuit was filed by investor-rights law firm Bernstein Liebhard in October after the FDA advisory committee rejected oliceridine. According to the lawsuit, Trevena executives, led by recently retired Trevena CEO Maxine Gowen, misled shareholders regarding an April 2016 end-of-phase meeting with the FDA. The lawsuit suggests that the company painted a rosy picture regarding the meeting with the FDA as the company planned to take oliceridine into Phase III trials.
Trevena 股价周一飙升近120%,此前该公司宣布,已为其静脉注射类阿片镇痛药物奥利塞定找到了前进道路。 美国食品药品监督管理局(Food and Drug Administration)( FDA )在一个咨询委员会否决该药物一个月后,于11月向该公司发出了完整的回应函。当 FDA 发布 CRL 时,监管机构要求提供更多的 QT 延长的临床数据,并指出提交的安全数据库不适合建议的剂量。Trevena 在11月说, FDA 还要求提供某些额外的非临床数据和验证报告。 然而,总部位于宾夕法尼亚州的 Trevena 周一表示,在与 FDA 举行了 A 型会议之后, FDA 为未来提供了希望。Trevena 周一表示,它将很快向 FDA 提交一份详细的协议和分析计划,在反馈之后,将在2019年上半年启动所需的研究。FDA 同意公司目前的安全数据库将支持每天最大剂量27毫克的标签。Trevena 还指出, FDA 要求该公司对健康志愿者进行研究,以收集所要求的 QT 间期数据。FDA 说,这项研究应该包括安慰剂和阳性对照的药物。不需要额外的疗效数据。该公司表示, FDA 确实要求提供与9662代谢物特性相关的非临床数据,以及重新提交奥利塞汀 NDA 时的剩余产品验证报告。 Trevena 总裁兼首席执行官 Carrie L . Bourdow 表示, FDA 的会议结果令该公司感到鼓舞,并认为这是监管机构批准的一条道路。 Bourdow 在一份声明中表示:“我们仍致力于确保需要静脉类阿片类药物治疗中度至重度急性疼痛的医院患者能够获得安全有效的治疗方案。” Trevena 遇到了橄榄油穿过终点线的问题。FDA 不仅在2018年否决了该药品,而且在2017年后期分析后,公司也存在该药品的问题。在进行了第三阶段的研究之后,分析人士质疑这种药物是否能与吗啡区别开来,特别是在某些安全措施方面。这导致该公司发生重组,约30%的员工下岗,以提供资金支持继续发展阿片类药物治疗。 虽然该公司确实有一条可能获得奥利塞定批准的道路,但 Trevena 是集体诉讼的主题。这起诉讼是由投资者权利律师事务所 Bernstein Liebhard 在 FDA 咨询委员会驳回奥利西丁后于10月提起的。根据诉讼, Trevena 高管在最近退休的 Trevena 首席执行官 Maxine Gowen 的带领下,在2016年4月与 FDA 的一次阶段性会议上误导了股东。诉讼表明,由于公司计划将奥利西丁纳入 III 期试验,公司在与 FDA 的会议上画了一幅乐观的画面。

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