FDA Accepts Regulatory Submission and Grants Priority Review for Lofexidine

US WorldMeds announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of the New Drug Application (NDA) 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 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 product's development also involved an extensive clinical pharmacology program, including studies to investigate concomitant administration of lofexidine with methadone, buprenorphine and naltrexone. 

"The symptoms of withdrawal are agonizing and present a significant barrier to successful opioid discontinuation," said Mark Pirner, M.D., Ph.D., senior medical director, clinical research. "Opioid withdrawal is an important step that everyone at risk of physical dependence or addiction to opioids must face in their journey to discontinue opioids or bridge to other treatment and recovery steps. 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."