DURECT Corp. (DRRX:NASDAQ) responded to the complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding Posimir, or bupivacaine extended-release solution, it announced in a news release.
The company submitted a full response rather than another new drug application. As such, the FDA's review period of it is expected to be about six months.
To formulate its response, DURECT employed the services of adviser Dr. Lee S. Simon, physician, scientist, principal at the FDA advisory firm, SDG LLC and former director of the agency's analgesic, anti-inflammatory and ophthalmologic drug products division. He reviewed and evaluated the company's existing Posimir package and the issues raised in the CRL then guided DURECT in its response to the FDA. The submission addresses the concerns of the FDA and asks it to approve Posimir.
"We believe that the submitted response to the CRL includes multiple positive adequate and well controlled trials and addresses the issues raised in the FDA's Complete Response Letter," Simon said in the release.
DURECT management believes that were Posimir approved, it could help address the need for additional long-acting, non-opioid products for postoperative pain, the company's president and CEO James E. Brown noted in the release.
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