FDA rejects Charleston and Daiichi's opioid candidate

• Daiichi Sankyo (OTCPK:DSNKY) and collaboration partner Charleston Laboratories announce that the FDA has issued a Complete Response Letter (CRL) regarding the Daiichi's New Drug Application (NDA) seeking approval of CL-108 (hydrocodone, acetaminophen, promethazine) for the management of severe pain.
• The companies do not provide the specific reasons for the rejection but say they intend to work closely with the agency to address the issues.
• Daiichi has commercialization rights in the U.S. under the companies' August 2014 collaboration agreement while Charleston will supply product and retain the right to co-promote this and other hydrocodone products in the U.S.