Pain Therapeutics Gets CRL From FDA For REMOXY ER Extended-Release Capsules CII

(RTTNews) - DURECT Corp. (DRRX) announced that its licensee, Pain Therapeutics (PTIE) has received a Complete Response Letter from the U.S. Food and Drug Administration for Pain Therapeutics' New Drug Application or NDA for REMOXY ER or 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."

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 $5 million, pending discussions with the FDA and outside clinical/regulatory consultants.