The U.S. Food and Drug Administration has granted priority review of the new drug application (NDA) for US WorldMeds’ lofexidine, an investigational treatment for opioid withdrawal.

During lofexidine’s development, the FDA granted it fast track status, a process designed to facilitate and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Lofexidine’s NDA submission is supported by two randomized, double-blind, placebo-controlled clinical trials and several supporting studies to characterize the safety of the product in a total of more than 1,000 patients. 

“The symptoms of withdrawal are agonizing and present a significant barrier to successful opioid discontinuation,” said Mark Pirner, senior medical director, clinical research, US WorldMeds. “The FDA’s decision to grant priority review to our lofexidine NDA highlights the critical role withdrawal management plays in the urgent need to address opioid abuse and misuse.”