LUCEMYRA demonstrated significant improvement when symptoms were most severe1,2

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
5-day study design1,2

US-based, Phase 3, randomized, multicenter, double-blind, placebo-controlled study involving patients (N=264) who were dependent on opioids (based on DSM-IV™ criteria). 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. During the 5-day treatment phase, one cohort received LUCEMYRA 2.88 mg total daily (0.72 mg four times daily), while the other cohort received a matching placebo dose four times daily. All patients received four placebo tablets QID on Days 6 and 7. On Day 8, patients did not receive medication and were discharged after completing the required assessments. Efficacy and safety were also assessed on Days 6-7. Clinical endpoints included mean SOWS-Gossop total score on Days 1 through 5 of treatment, and proportion of patients who completed 5 days of treatment.

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

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)

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

  • Both groups receiving LUCEMYRA demonstrated statistically significant lower average daily SOWS-Gossop scores over Days 1 through 7, as compared with the placebo group
7-day study design1

US-based, Phase 3, randomized, multicenter, double-blind, placebo-controlled, two-part study examining the efficacy, safety, and dose-response in patients (N=602) dependent on opioids (based on DSM-IV™ criteria). The first part of the study included 3 cohorts treated over 7 days: one arm received LUCEMYRA 2.16 mg total daily (0.54 mg four times daily); the second arm received LUCEMYRA 2.88 mg total daily (0.72 mg four times daily); and the third arm received a matching placebo dose four times daily. Clinical endpoints included mean SOWS-Gossop total score on Days 1 through 7 of treatment, and proportion of patients who completed 7 days of treatment. 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.

References:

  1. LUCEMYRA® (lofexidine) [Prescribing Information]. Louisville, KY: US WorldMeds, LLC; 2018.
  2. Data on file. Louisville, KY: US WorldMeds; 2017.
  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.