FDA panel to review US WorldMeds' opioid withdrawal candidate

FDA said its Psychopharmacologic Drugs Advisory Committee will meet on March 27 to discuss an NDA from US WorldMeds LLC (Lousiville, Ky.) 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 next quarter (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...