Further Complete Response Letter for Remoxy ER for long term abuse deterrent treatment for pain. Pain Therapeutics.

DURECT Corporation has announced that its licensee, Pain Therapeutics reported that it received a Complete Response Letter from the FDA for Pain Therapeutics' New Drug Application (NDA) for REmoxy ER (oxycodone) extended-release capsules CII, which concluded that "The data submitted in [the] NDA do not support the conclusion that the benefits of [Remoxy] Extended-Release Capsules outweigh the risks."

Pain Therapeutics further announced a strategic reorganization to align its resources on advancing its drug and diagnostic assets in Alzheimer's disease.

Comment: Regulators have now issued four Complete Response Letters (CRLs) for Remoxy since December 2008. The letters cited a variety of problems with the drug, including inconsistent release performance during in vitro testing? and the need for more data about its abuse-deterrent properties.It looks as though this latest setback is the end of the road for Remoxy.