Durect Corporation announced that its licensee, Pain Therapeutics has received a Complete Response Letter from the US Food and Drug Administration (FDA) for Pain Therapeutics' New Drug Application (NDA) for Remoxy ER (oxycodone) extended-release capsules CII. Based on its review, the FDA has determined that the NDA cannot be approved in its present form and specifies additional actions and data that are needed for drug approval.

In a press release issued this morning by Pain Therapeutics, Pain Therapeutics states that "The CRL focuses on the abuse-deterrent properties of Remoxy ER and proposed drug labeling.  The CRL makes no mention of clinical safety, drug efficacy, manufacturing, stability, bioequivalence or any other issues from a prior Complete Response Letter."

The announcement continues that "Pain Therapeutics is evaluating the CRL and plan further discussions with the FDA.  The CRL specifies additional actions that are needed in order to obtain approval of Remoxy ER with label claims against three routes of abuse (i.e., injection, inhalation and snorting).  These actions may take approximately a year to conduct and may cost approximately $5MM, pending discussions with the FDA and outside clinical/regulatory consultants."

In addition, the Pain Therapeutics provides the following details of the Complete Response Letter (CRL):

“The CRL focuses on the actions and studies that are needed in order to obtain approval of Remoxy ER with label claims on three routes of abuse (i.e., injection, inhalation and snorting). In conducting the following studies, we will generally compare Remoxy ER vs. one or more commercially available oxycodone ER drug product; To support a potential drug label claim against abuse by injection: Repeat an injectability/syringeability study using thin films of drug, smaller volumes of solvents, additional mixed solvents and alternative extraction methods and syringe filter; To support a potential drug label claim against abuse by inhalation: Repeat a volatilization study using the same thickness for each drug to increase surface area; To support a potential drug label claim against abuse by snorting: Conduct an intranasal abuse potential study in human volunteers (i.e., not the animal data we had submitted) with drug applied directly inside the human nasal cavity.

In addition, we had proposed in the Remoxy NDA a label claim against abuse by chewing.  Our proposal was based on clinical results of an oral human abuse potential study that met all four co-primary endpoints with statistical significance and that also met several, but not all, secondary endpoints.  The CRL asks us to submit a revised proposed label to indicate results of this study do not support a label claim against abuse by chewing."

In December 2002, Durect licensed to Pain Therapeutics the exclusive right to develop and commercialize on a worldwide basis Remoxy ER  and other specified opioid analgesics utilizing Durect's Oradur extended-release, abuse-deterrent technology. Under the terms of that license, Pain Therapeutics funds the development program including reimbursing Durect for formulation and other work performed for Pain Therapeutics.  Durect may also receive additional payments if certain development and regulatory milestones are achieved.  Durect is eligible to also receive royalties of between 6.0% to 11.5% of net sales if Remoxy ER is commercialized, and may receive additional income from the sale of key excipients supplied by Durect for use in the manufacture of Remoxy ER.

Durect is a biopharmaceutical company focused on two areas of active drug development: new therapeutics based on its proprietary drug delivery platforms and new chemical entities derived from its Epigenomic Regulator Program.