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.

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 following abrupt opioid discontinuation: 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. 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 (but not to exceed 2.88 mg total daily dose). 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.