US WorldMeds' Opioid Withdrawal Drug Lofexidine Heads To US FDA Panel
Sponsor seeks a novel claim for facilitating completion of opioid discontinuation treatment, but agency's external experts will weigh in on evidentiary threshold for such an indication; FDA staff give mixed review to patient-reported outcomes instrument used as primary endpoint in two pivotal trials.
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While symptom reduction is a clinically meaningful benefit that can support an indication, data on withdrawal treatment completion can provide confirmatory evidence of a drug's effect, US FDA advisory committee members say in their review of US WorldMeds' lofexidine.
But Psychopharmacologic Drugs Advisory Committee says US WorldMeds' second proposed indication for facilitating completion of opioid discontinuation treatment is not supported by data from two short-term studies in an 'idealized' population.