2月12日， Durect公司收到FDA关于Posidur的完全答复函，FDA认为目前该药安全性数据不足，要求补充临床试验证明该药的安全性。POSIDUR是应用SABER技术开发的长效布比卡因制剂，可维持72小时的局部麻醉作用，缓解手术后疼痛。
DURECT Receives Complete Response Letter from FDA for POSIDUR(TM) (SABER(R)-Bupivacaine)
CUPERTINO, Calif., Feb. 12, 2014 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for POSIDUR(TM) (SABER(R) -Bupivacaine), an investigational drug for administration into the surgical site to produce post-surgical analgesia. Based on its review, the FDA has determined that they cannot approve the NDA in its present form, stating the NDA does not contain sufficient information to demonstrate that POSIDUR is safe when used in the manner described in the proposed label, and the FDA has indicated that additional clinical safety studies need to be conducted. DURECT is evaluating the issues described in the Complete Response Letter and plans to have further discussions with the FDA around them.
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"In the coming months, we intend to work with the FDA to gain more clarity on the next steps that would be required to address the issues cited in the Complete Response Letter," stated James E. Brown, DVM, President and CEO of DURECT Corporation.
Conference Call and Webcast
A live audio webcast of a conference call will be broadcast over the internet at 8:30 a.m. Eastern Time on February 13 and is available by accessing DURECT's homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT's website under Audio Archive in the "Investor Relations" section.
About POSIDUR
POSIDUR is a post-operative pain relief depot that utilizes DURECT's patented SABER(R) technology to deliver bupivacaine to provide up to three days of pain relief after surgery. We are in discussions with potential partners regarding licensing development and commercialization rights to POSIDUR, for which we hold worldwide rights.
About DURECT Corporation
DURECT is a specialty pharmaceutical company developing innovative drugs for pain and other chronic diseases, with late-stage development programs including Remoxy(R) , POSIDUR(TM) , ELADUR(R) , and TRANSDUR(R) -Sufentanil. DURECT's proprietary oral, transdermal and injectable depot delivery technologies enable new indications and superior clinical/commercial attributes such as abuse deterrence, improved convenience, compliance, efficacy and safety for small molecule and biologic drugs. For more information, please visit www.durect.com.
DURECT Forward-Looking Statement
本新闻稿中关于POSIDUR，POSIDUR的潜在利益和用途，我们正在进行的审查以及与FDA的有关POSIDUR NDA批准的互动以及解决有关POSIDUR的所有未解决监管问题的潜力的陈述均为前瞻性陈述，涉及可能导致实际结果与此类前瞻性陈述产生重大差异的风险和不确定性。潜在的风险和不确定性包括但不限于FDA或其他监管机构做出不利决定的风险，包括产品未批准，由于FDA或监管机构施加的要求而导致的延误和额外费用，可能无法充分解决FDA对POSIDUR NDA的所有关注，或者在解决此类关注方面可能会有所延迟，FDA可能未批准POSIDUR的监管批准的可能性，由于额外测试或使用POSIDUR所引起的潜在不利影响的风险以及FDA或其他监管机构认为我们产生或可能产生的数据的可能性不足支持POSIDUR监管批准的机构。有关这些及其他风险的更多信息，包含在2013年11月5日的DURECT表格10-Q中，标题为“风险因素”。
NOTE: POSIDUR(TM) , SABER(R) , TRANSDUR(R) , and ELADUR(TM) are trademarks of DURECT Corporation. Remoxy, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.
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