FDA reviewing US WorldMeds’ opioid withdrawal candidate

FDA accepted and granted Priority Review to an NDA for lofexidine from US WorldMeds LLC (Louisville, Ky.) to mitigate symptoms associated with opioid withdrawal. Its PDUFA date is in 2Q18.

Lofexidine is an agonist of adrenergic receptor alpha 2 (ADRA2). The company said lofexidine would be the first FDA-approved non-opioid, non-addictive drug to manage opioid withdrawal...