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News Breaks
February 13, 2014
07:55 EDTDRRX, DRRXDURECT to host conference call
Conference call to discuss response letter from FDA for POSIDUR will be held on February 13 at 8:30 am. Webcast Link
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November 11, 2014
16:09 EDTDRRXDURECT provides update on FDA communication over POSIDUR
DURECT announced that it has received meeting minutes from its face-to-face meeting with the FDA on September 23, regarding the POSIDUR program. In the February Complete Response Letter, the FDA indicated that multiple safety trials would be required to support a broad indication. DURECT inquired whether it would be possible to expedite approval by pursuing an initial indication of soft tissue post-surgical analgesia without conducting additional trials. The company said the FDA has indicated that in this scenario, it should be acceptable to conduct only one additional soft tissue clinical trial, the size of which is not yet defined, to generate the data required for product approval, including safety data for POSIDUR compared to a non-SABER containing comparator and also product efficacy. "Based on the Complete Response Letter we anticipated that we would be required to do additional safety trials," stated James Brown, President and CEO of DURECT. "Over the coming months, we expect to have further communications with the FDA to refine the path forward."

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