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Lofexidine Demonstrates Efficacy During Early Opioid Withdrawal

October 05, 2019

SAN DIEGO—The opioid withdrawal drug lofexidine demonstrated statistically significant efficacy across a half-dozen patient- and clinician-reported outcomes during the first 7 days after immediate opioid cessation, according to study presented at Psych Congress 2019.

“Patients with opioid use disorder frequently continue opioids to avoid opioid withdrawal syndrome,” wrote poster presenter Mark Pirner, MD, PhD, and coauthor Thomas Clinch, MS. “Lofexidine is an alpha2-adrenergic receptor agonist approved for mitigation of opioid withdrawal syndrome symptoms.”

The double-blind, 7-day trial compared the effect of daily lofexidine 2.16 mg, lofexidine 2.88 mg, and placebo in 602 adults with opioid dependence following abrupt opioid withdrawal. Of the participants, 71% were male, 74% were white, and 83% used heroin as their primary opioid.

Both lofexidine 2.16 mg/day and 2.88 mg/day showed statistically significant efficacy for opioid withdrawal syndrome across all participant- and clinician-reported outcomes. The study’s primary outcome gauged the medication’s effect using the Short Opiate Withdrawal Scale. Five secondary outcomes looked at the effect on the Objective Opiate Withdrawal Scale, the modified Clinical Global Impressions Scale (for subject and rater), the Visual Analog Scale for Efficacy, and the Clinical Opiate Withdrawal Scale.

“Lofexidine has demonstrated consistent efficacy during early withdrawal, a critical period for opioid cessation and subsequent transition to long-term treatment,” the researchers wrote.

US WorldMeds sponsored the study.

—Jolynn Tumolo


Pirner M, Clinch T. Consistent efficacy of lofexidine across primary and secondary efficacy outcomes in a large, placebo-controlled trial. Poster presented at Psych Congress 2019: October 3-6, 2019; San Diego, CA. Poster 241. 

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