FDA panel backs US WorldMeds' opioid withdrawal candidate

US WorldMeds LLC (Louisville, Ky.) said FDA's Psychopharmacologic Drugs Advisory Committee voted 11-1 to recommend approval of an NDA for lofexidine to reduce symptoms associated with opioid withdrawal and facilitation of completion of opioid discontinuation treatment. The NDA is under Priority Review and its PDUFA date is in 2Q18 (see BioCentury, Dec. 1, 2017).

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