Biotech Watch January 13-17: 4 Heavy Weight Events

Biotech Watch

DURECT Corporation (DRRX): POSIMIR Advisory Committee Meeting


In the last of Advisory Committee Meetings for the week, we have DURECT Corporation, who will be sitting in on an Advisory Committee Meeting scheduled for January 16, 2020.

At the meeting, we’ll have a similar situation to the IPCIF meeting. In February of 2014, the FDA handed down a Complete Response Letter surrounding POSIMIR, outlining concerns with approval and that it could not approve the drug at that time.

Nonetheless, the FDA has recently accepted a response to the CRL and is considering approval for the drug as we speak. Like the IPCIF Advisory Committee Meeting, the PDUFA date surrounding POSIMIR has yet to be determined.

POSIMIR is yet another pain drug. However, the drug is a non-opioid option, which will likely play to its favor. Nonetheless, we will see how well DURECT addressed the FDA’s concerns with the Advisory Committee Meeting ahead.

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