FDA provides complete response letter to application for Remoxy ER (oxycodone) extended-release capsules in pain treatment- Pain Therapeutics

Durect Corporation has announced that its licensee, Pain Therapeutics has received a Complete Response Letter from the FDA for Pain Therapeutics' New Drug Application (NDA) for Remoxy ER (oxycodone) extended-release capsules CII for pain treatment. 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. 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 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.