US-based, Phase 3, randomized, multicenter, double-blind, placebo-controlled study involving patients who were dependent on opioids1*

Study data involving patients who were dependent on opioids
  • The study utilized a parallel-group design that consisted of two main phases conducted over an 8-day period: a 5-day treatment phase and a 2-day post-treatment phase. On Day 8, patients did not receive medication and were discharged after completing the required assessments1
  • Efficacy and safety were also assessed on Days 6-72

*Patients met DSM-IV™ criteria for opioid dependence

Patients received either LUCEMYRA 0.72 mg or matching placebo, four times daily (QID), for a total daily dose of 2.88 mg

All patients received four placebo tablets QID on Days 6 and 7

Clinical endpoints

  • Mean Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) total score on Days 1 through 5 of treatment
  • Proportion of patients who completed 5 days of treatment

LUCEMYRA demonstrated significant improvement when symptoms were most severe1,2

Chart: Clinical Trial - Lofexidine showed significant improvement when symptoms were most severe

SOWS-Gossop is a subject-rated instrument that measures symptom severity3

  • Reductions in SOWS-Gossop scores indicate alleviation of opioid withdrawal symptoms
  • Scoring differences of approximately 2–4 points represent a clinically meaningful improvement on SOWS-Gossop assessments

Patients receiving LUCEMYRA were significantly more likely to stay in treatment, as compared with placebo1,2

Chart: Retention analysis for LUCEMYRA

LUCEMYRA significantly improved the percentage of patients who successfully completed withdrawal treatment1,2

LUCEMYRA vs Placebo data for patients

Approximately half of patients who received LUCEMYRA completed the study, versus one-third of patients who received placebo (P=0.0087)

US-based, Phase 3, randomized, multicenter, double-blind, placebo-controlled, two-part study that examined efficacy, safety, and dose-response in patients dependent on opioids1*

LUCEMYRA study design: 7-day treatment
  • The first part of the study included three cohorts treated over 7 days
  • No patient received LUCEMYRA for more than 14 days
  • The second part of the study was an open-label design where all patients who successfully completed Days 1–7 were eligible to receive open-label treatment with variable-dose LUCEMYRA treatment for up to an additional 7 days (Days 8–14)

*Patients met DSM-IV™ criteria for opioid dependence

The three cohorts included one arm receiving LUCEMYRA 2.16 mg total daily (0.54 mg four times daily), a second arm receiving LUCEMYRA 2.88 mg total daily (0.72 mg four times daily), and a third arm receiving a matching placebo dose four times daily

The second part of the study (Days 8–14) was an open-label design where all patients who successfully completed Days 1–7 were eligible to receive open-label treatment with variable-dose LUCEMYRA treatment as determined by the investigator

Clinical endpoints

  • Mean SOWS-Gossop total score of treatment and placebo from Days 1 through 7
  • Proportion of patients that completed 7 days of treatment

LUCEMYRA significantly reduced withdrawal symptoms over the course of 7-day treatment1,2

Chart: Clinical Trial - Lofexidine reduced withdrawal symptoms over the course of 7-days
  • Both groups receiving LUCEMYRA demonstrated statistically significant lower average daily SOWS-Gossop scores over Days 1 through 7, as compared with the placebo group
  • Successful OWS management can help both physically dependent and OUD patients through opioid withdrawal
  • When treating patients with OUD, LUCEMYRA should only be used in conjunction with a comprehensive management program for the treatment of Opioid Use Disorder

References:

  1. LUCEMYRA™ (lofexidine) [Prescribing Information]. Louisville, KY: US WorldMeds, LLC; 2018.
  2. Data on file, US WorldMeds.
  3. Vernon MK, Reinders S, Mannix S, et al. Psychometric evaluation of the 10-item Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop) in patients undergoing opioid detoxification. Addict Behav. 2016;60:109-116.