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

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