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FDA Committee Recommends Approval of Opioid Withdrawal Drug
Drugs Submissions and Approvals
The Psychopharmacologic Drugs Advisory Committee voted to recommend approval of an NDA for lofexidine hydrochloride for mitigation of opioid withdrawal symptoms.
The committee voted 12 to zero in favor of the effectiveness of the drug developed by UK-based Britannia Pharmaceuticals and licensed to US WorldMeds for launch in the U.S., and 11 to one in favor of recommending the drug for approval. The sole dissenting vote cited concerns about lack of long-term safety data.
Committee members noted that the final votes covered multiple issues, including indication and dosage, and said separate votes for each would have been preferable.