FDA stalls Charleston and Daiichi Sankyo opioid candidate

The Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for CL-108 (hydrocodone, acetaminophen, promethazine).

The drug, which is being developed by Japan’s Daiichi Sankyo (TYO: 4568) with privately held US company Charleston Laboratories, is an investigational treatment for the management of pain severe enough to require an opioid analgesic while preventing or reducing the associated opioid-induced nausea and vomiting when alternative treatments for pain are inadequate.

The CRL stated that the NDA in its present form was not approved and provided guidance on information needed to resolve matters identified. The companies do not provide the specific reasons for the rejection but said they intend to work closely with the FDA to address the points raised in this action.