21 November 2017 - US WorldMeds today announced that the U.S. FDA has accepted and granted priority review of the new drug application for lofexidine, an investigational product to mitigate symptoms associated with opioid withdrawal and facilitate completion of opioid discontinuation treatment. 

Priority Review is granted to submissions for medications that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. 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. The Prescription Drug User Fee Act (PDUFA) date for lofexidine occurs during the second quarter of 2018.

Lofexidine's submission is supported by two randomised, double-blind, placebo-controlled clinical trials and several supporting studies to characterise the safety of the product in a total of more than 1,000 patients. The product's development also involved an extensive clinical pharmacology program, including studies to investigate concomitant administration of lofexidine with methadone, buprenorphine and naltrexone. 

Read US WorldMeds press release