Pfizer Inc. (PFE) announced that a Complete Response Letter was received from the U.S. Food and Drug Administration on the resubmission to the new drug application for REMOXY Extended-Release Capsules CII.
REMOXY is an investigational extended-release oral formulation of oxycodone for the relief of moderate to severe pain requiring continuous, around-the-clock opioid treatment. REMOXY was developed by Pain Therapeutics, Inc. (PTIE) using DURECT Corp.'s (DRRX) ORADUR technology, which is designed to discourage common methods of tampering.
Pfizer is working to evaluate the issues described in the Complete Response Letter and plans to have further discussions with FDA around them.
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