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Psychopharmacologic Drugs Advisory Committee

On Tuesday, March 27, 2018, the Psychopharmacologic Drugs Advisory Committee (PDAC) discussed and voted on a new drug application (NDA) for Lucemyra (lofexidine) hydrochloride, submitted by US WorldMeds, LLC (USWM), proposed for the mitigation of symptoms associated with opioid withdrawal and the facilitation of completion of opioid discontinuation treatment.

·      The Committee voted unanimously (12 of 12 members, with no abstentions) that the data provide substantial evidence of effectiveness of lofexidine for the mitigation of symptoms associated with opioid withdrawal.

·      A majority of the Committee (11 of 12 members, with no abstentions) voted to recommend approval of the lofexidine NDA.