Durect (DRRX)

[realfast95]

$PTIE earnings report update on $DRRX product

Update on REMOXY ER(TM) (extended-release oxycodone capsules CII)

We are still targeting resubmission of the New Drug Application (NDA) for REMOXY ER for Q1 2018. In Q1 2017, we met with the U.S. Food and Drug Administration (FDA) to better understand the requirements for the regulatory approval of REMOXY ER. These discussions confirmed two key requirements are needed for the resubmission and potential approval of the REMOXY NDA:

-- A clinical abuse potential study via the nasal route of abuse; and

-- A non-clinical (in vitro) abuse potential study using household solvents.

In Q2 2017, we initiated an abuse potential study via the nasal route of abuse with REMOXY ER. We recently completed patient enrollment for this study. We expect to announce top-line results by year-end 2017. In Q2 2017, we also finalized testing methodologies for a non-clinical (in vitro) abuse potential study that evaluates the REMOXY formulation in a variety of household solvents.