FDA Grants Priority Review to Lofexidine for Opioid Withdrawal Management

NDA submission supported by two placebo-controlled clinical trials and several supporting studies
NDA submission supported by two placebo-controlled clinical trials and several supporting studies

US WorldMeds announced that the Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for lofexidine to manage the symptoms associated with opioid withdrawal and to facilitate completion of opioid discontinuation treatment.

The NDA contained data from 2 randomized, double-blind, placebo-controlled trials and other supporting studies to establish drug safety in >1,000 patients. Study data indicated a significant reduction in the severity of withdrawal symptoms with lofexidine vs. placebo among patients experiencing opioid withdrawal. The clinical pharmacology program also included studies exploring lofexidine use with concomitant methadone, buprenorphine, and naltrexone. 

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Lofexidine, an oral tablet, is an investigational oral, selective alpha 2-adrenergic receptor agonist that works by reducing the release of norepinephrine. If approved, it would be the first non-opioid, non-addictive treatment for this condition. 

The Prescription Drug User Fee Act (PDUFA) date for lofexidine is anticipated for the second quarter of 2018.

For more information call (888) 900-8796 or visit USWorldMeds.com.