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FDA advisory committee recommends approval of lofexidine for opioid withdrawal symptoms

by
Optum Workers' Comp
| Apr 06, 2018

An advisory committee of the U.S. Food and Drug Administration (FDA) voted to approve a non-opioid, lofexidine hydrochloride, to alleviate the symptoms of abrupt opioid withdrawal. Lofexidine, an alpha-2 adrenergic agonist that works by reducing the release of norepinephrine, is similar to clonidine, which has been used off-label for the management of opioid withdrawal symptoms. According to this report, lofexidine has been found to be safe and effective in reducing symptoms of nausea, vomiting, anxiety, diarrhea and the overall feeling of sickness during withdrawal. Lofexidine has been marketed in the United Kingdom (UK) as BritLofex since 1992 to relieve symptoms in patients undergoing opioid detoxification.

The Psychopharmacologic Drugs Advisory Committee agreed that, if approved by the FDA, lofexidine would be labeled as Lucemyra by US WorldMeds, LLC. The company proposed selling two different doses based on clinical studies, 2.4 mg per day and 3.2 mg per day. Despite the 11-1 vote to approve this medication, most of the members did not believe that the 3.2 mg daily dose should be approved, as it was associated with a higher incidence of cardiovascular side effects, such as low blood pressure (hypotension), abnormally slow heart rate (bradycardia) and fainting caused by a drop in blood pressure (syncope). In the UK, the maximum recommended dose of BritLofex is 2.4 mg per day, taken in divided doses, for seven to ten days. The advisory committee also suggested monitoring for prolonged QT intervals, a heart rhythm disorder that can cause serious irregular heart rhythms, if lofexidine is approved and marketed in the United States.  

The FDA is not bound by the recommendations of its advisory committee and will consider their guidance during a review of the New Drug Application for Lucemyra. The FDA is slated to make its decision by May 26, 2018.

Sources:

  1. FDA Panel Backs Approval of Lofexidine for Opioid Withdrawal. Medscape Medical News. March 28, 2018. Available at: https://www.medscape.com/viewarticle/894510?nlid=121586_745&src=WNL_mdplsfeat_180403_mscpedit_phar&uac=84633DG&spon=30&impID=1598466&faf=1#vp_1. Accessed April 4, 2018.
  2. BritLofex Tablets 0.2 mg (lofexidine hydrochloride). Britannia Pharmaceuticals Limited. eMC website. Available at: https://www.medicines.org.uk/emc/product/1483. Accessed April 4, 2018.




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