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Lucemyra Approval History

Reviewed on May 16, 2016 by J.Stewart B.Pharm.

  • FDA approved: Yes (First approved May 16, 2018)
  • Brand name: Lucemyra
  • Generic name: lofexidine hydrochloride
  • Dosage form: Tablets
  • Company: US WorldMeds
  • Treatment for: Opiate Withdrawal

Lucemyra (lofexidine hydrochloride) is a selective alpha 2-adrenergic receptor agonist indicated for reducing the severity of withdrawal symptoms in patients experiencing opioid withdrawal.

Dosage and Administration

The usual dosage is three 0.18 mg tablets taken orally four times daily. Treatment may be continued for up to 14 days, with dosing guided by symptoms. Lucemyra should be discontinued with a gradual dose reduction over 2 to 4 days.

Warnings and Precautions

  • Risk of Hypotension, Bradycardia, and Syncope: Patients should be alert for any symptoms of low blood pressure or pulse (e.g., dizziness, lightheadedness, or feelings of faintness at rest or on abruptly standing). Patients should know how to reduce the risk of serious consequences should hypotension occur (sit or lie down, carefully rise from a sitting or lying position). Patients who are using Lucemyra at home should be capable of, and instructed on self-monitoring for hypotension, orthostasis and bradycardia, and advised to withhold doses and contact their healthcare provider for instructions if they experience these signs or related symptoms. Patients should avoid becoming dehydrated or overheated, which may potentially increase the risks of hypotension and syncope.
  • Risk of QT Prolongation: Lucemyra prolongs the QT interval. Use should be avoided in patients with congenital long QT syndrome. ECG monitoring is advised in patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias, hepatic or renal impairment, or in patients taking other medicinal products that lead to QT prolongation.
  • Increased Risk of CNS Depression with Concomitant use of CNS Depressant Drugs: Lucemyra potentiates the CNS depressant effects of benzodiazepines and may potentiate the CNS depressant effects of alcohol, barbiturates, and other sedating drugs.
  • Increased Risk of Opioid Overdose after Opioid Discontinuation: Patients who complete opioid discontinuation are at an increased risk of fatal overdose should they resume opioid use. Lucemyra should be used in conjunction with a comprehensive management program for the treatment of opioid use disorder, and patients and caregivers should be aware of the increased risk of overdose.
  • Risk of Discontiuation Symptoms: Patients should not to discontinue therapy without consulting their healthcare provider. When discontinuing therapy, the dose must be reduced gradually.

Adverse Reactions

Most common adverse reactions (incidence ≥ 10% and notably more frequent than placebo) are orthostatic hypotension, bradycardia, hypotension, dizziness, somnolence, sedation, and dry mouth.

Drug Interactions

  • Methadone: Methadone and Lucemyra both prolong the QT interval. ECG monitoring is recommended when used concomitantly.
  • Oral Naltrexone: Comcomitant use may reduce efficacy of oral naltrexone.
  • CYP2D6 Inhibitors: Concomitant use of paroxetine resulted in increased plasma levels of Lucemyra. Monitor for symptoms of orthostasis and bradycardia with concomitant use of a CYP2D6 inhibitor.

Development History and FDA Approval Process for Lucemyra

May 16, 2018Approval FDA Approves Lucemyra (lofexidine hydrochloride) as the First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms
Mar 27, 2018FDA Advisory Committee Votes in Favor of Lucemyra (lofexidine) for the Mitigation of Opioid Withdrawal Symptoms
Nov 21, 2017U.S. FDA Accepts Regulatory Submission and Grants Priority Review for US WorldMeds' Lofexidine
Jun 16, 2008US WorldMeds Completes Phase III Trial of Lofexidine for Treatmentof Opiate Withdrawal Symptoms

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.