The study will enroll approximately 125 patients randomized 4:1 to dose regimens of twice a day dosing of 30µg, 60µg, 90µg, 120µg, and 180µg of BXCL501 or placebo. Male and female adults with opioid use disorder who are physically dependent on opioids will be enrolled to treat symptoms of acute opioid withdrawal following discontinuation of morphine maintenance. Patients will be domiciled in an inpatient unit to remain under medical supervision after deemed eligible for the study. Efficacy and safety assessments will be conducted periodically before and after dosing.
This is a dose-ranging study to support the safety and efficacy evaluation of BXCL501 to treat the symptoms of acute opioid withdrawal. The BXCL501-201 study is designed to characterize the efficacy, safety, tolerability, and pharmacokinetics of escalating doses of BXCL501 (sublingual film formulation of DEX, HCl) versus placebo following discontinuation of morphine maintenance in patients with opioid use disorder who are physically dependent on opioids.