Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence

This was a prospective, randomized, multicenter, blinded, parallel-group, active-controlled, non-inferiority study conducted at 13 sites within the US. Eligible patients participated in 8 treatment visits on Days 1, 2, 3, 4, 8, 15, 22, and 29. Effectiveness of treatment was assessed as follows:

• Retention in treatment at Day 3
• Clinician and patient assessments of opioid withdrawal symptoms
• Assessment opioid cravings

Inclusion criteria

• Able to read, comprehend, and sign the informed consent form and willingly provide written informed consent
• Prepared to engage in opioid replacement therapy and to abstain from opioid utilization other than the study drug, and from other illicit drugs
• Male or female, 18 to 65 years of age (inclusive)
• Met clinical criteria for opioid dependence in past 12 months based on DSM-IV-TR
• Provided buprenorphine-negative urine drug screen prior to randomization
• Provided negative urine pregnancy test
• Females of childbearing potential were required to be using a reliable method of contraception (e.g., hormonal, condom with spermicide, intrauterine device [IUD]) after the screening visit and for the duration of the study
• Participants receiving opioids for pain must receive clearance from their prescribing physician to be withdrawn from their prescribed opioids
• Generally good health as determined by the investigator
• Participants should demonstrate at least mild withdrawal symptoms (defined as a COWS score >9 at Day 1 predose)

Exclusion criteria

• Females who are pregnant or lactating, or planning to be pregnant during study
• Any previous prescribed treatment with buprenorphine monotherapy (e.g., generic buprenorphine sublingual tablets)
• Prescribed treatment with buprenorphine or naloxone within 90 days prior to start of treatment
• Methadone patients with any daily dose over 30 mg during the past week and who received the last dose of methadone less than 30 hours prior to start of treatment
• Participants who are unwilling or unable to comply with the requirements of the protocol
• Participants who are participating in any other clinical study in which medication(s) are being delivered or who have used an investigational drug or device within the last 30 days
• Participants with any known allergy or sensitivity or intolerance to buprenorphine, naloxone, or any related drug
• Participants who are on the staff, affiliated with, or a family member of the staff personnel directly involved with this study
• Participants with serious untreated Axis I DSM-IV-TR psychiatric comorbidity
• Tongue piercing or other piercings in the mouth, including lips and cheek
• Participants with current or history of clinically significant medical disorder or condition
• Participants who are human immunodeficiency virus (HIV)-seropositive with a CD4+ count <200 or active acquired immune deficiency syndrome (AIDS)
• Participants who have any Class III or IV congestive heart failure, symptomatic myocardial ischemia, a history of long QT syndrome.
• Participants who are currently taking Class 1A antiarrhythmic medications or Class III antiarrhythmic medications
• Participants who have uncontrolled hypertension or clinically significant ECG abnormalities
• Participants who have a pulse oximetry ≤93% at screening, due to any medical reason.
• Individuals with AST or ALT levels ≥3 X the upper limit of normal or total bilirubin or creatinine ≥1.5 X ULN, on the screening laboratory assessments
• Participants with known significant liver disease.
• Participants who take any medication, nutraceutical, herbal product with known CYP3A4 inhibition or induction properties within 14 days of screening.
• Participants who are at suicidal risk