Lofexidine Gets FDA Committee Nod for Opioid Withdrawal
US WorldMeds announced that the Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted in favor (11 to 1) of recommending approval of lofexidine (Lucemyra) for the mitigation of opioid withdrawal symptoms.
Lofexidine, an oral alpha-2 adrenergic receptor agonist, works by suppressing the neurochemical surge that produces the acute and painful symptoms of opioid withdrawal. The New Drug Application (NDA) for lofexidine contains data from 2 randomized, double-blind, placebo-controlled clinical trials and other supporting studies. In placebo-controlled trials, treatment with lofexidine resulted in less severe withdrawal symptoms and patients were more likely to finish opioid discontinuation treatment.
The FDA has set a target Prescription Drug User Fee Act (PDUFA) action date in the second quarter of 2018. Currently, the only product indicated for managing opioid withdrawal is methadone. If approved, lofexidine will be the first non-opioid medication indicated to mitigate opioid withdrawal symptoms.
For more information call (888) 900-8796 or visit USWorldMeds.com.