LUCEMYRA
Peaklofexidine hydrochloride
NDAORALTABLETPriority Review
Approved
May 2018
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
6/8 — Strong
Priority Review
LUCEMYRA (lofexidine hydrochloride) is alpha-2 adrenergic agonist that binds to receptors on adrenergic neurons. Approved for liver failure. First approved in 2018.
Drug data last refreshed 22h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LUCEMYRA (lofexidine hydrochloride) is an oral alpha-2 adrenergic agonist approved in 2018 for treatment of opioid withdrawal symptoms. It works by binding to alpha-2 receptors on adrenergic neurons, reducing norepinephrine release and decreasing sympathetic hyperactivity associated with withdrawal. The drug addresses a significant unmet need in addiction medicine by providing a non-opioid, non-controlled option for managing acute withdrawal.
$0.003BPart D
PeakProduct is in peak lifecycle stage with modest Medicare spending; commercial team is likely stable to optimizing awareness and access in addiction medicine.
Mechanism of Action
alpha-2 adrenergic agonist that binds to receptors on adrenergic neurons. This reduces the release of norepinephrine and decreases sympathetic tone.
Clinical Trials (3)
A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subjects
Started Jun 2025
0Opioid Withdrawal (Disorder)Opioid Use Disorder
A Study Evaluating the Relative Bioavailability of Lofexidine Granules for Reconstitution Compared to LUCEMYRA (Lofexidine) Tablets and the Effect of Food on the Bioavailability of the Lofexidine Granules for Reconstitution
Started Feb 2021
16 enrolled
Normal Healthy Volunteers
Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal
Started Aug 2019
4 enrolled
Opioid Withdrawal (Disorder)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.