An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects

Exclusion Criteria

• •1. Hypokalemia, hypomagnesemia, or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or clinically significant arrhythmias
• •2. History of Long QT Syndrome, or an immediate family member with this condition
• •3. Currently taking Class IA antiarrhythmic medications (eg, quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (eg, sotalol, amiodarone, dofetilide)
• •4. Uncontrolled hypertension defined as systolic blood pressure \>170 mmHg and diastolic blood pressure \>90 mmHg at Baseline
• •5. Pulse oximetry ≤93% at Baseline, regardless of cause
• •6. Clinically significant abnormality on 12-lead ECG, including a QTc interval \>490 milliseconds
• •7. Use of any medication, nutraceutical or herbal product with CYP3A4 inhibition or induction properties within the past 30 days (see Appendix 4 for a list of applicable drugs). This exclusion also extends to grapefruit juice and grapefruit juice-containing products as well as St. John's wort and St. John's wort-containing products (prescription or nonprescription drugs, vitamins, minerals, or dietary/herbal supplements).
• •8. Diagnosis of moderate to severe hepatic impairment
• •9. Use of an investigational drug or device within the last 30 days
• •10. Participation in a previous clinical study of BEMA Buprenorphine NX or BEMA Buprenorphine
• •11. History of hypersensitivity, allergy, or intolerance to buprenorphine, naloxone, or related drugs
• •12. Pierced tongue or mouth
• •13. Any clinically significant abnormality of the buccal mucosa which could impact drug absorption
• •14. Suicidal risk, as determined by meeting any of the following:
• •1. History of suicidal ideation ≤ 3 months prior to Baseline with a score of 4 (intent to act) or 5 (specific plan and intent) on the eC-SSRS
• •2. History of suicidal behavior ≤ 1 year prior to Baseline (actual attempt, interrupted attempt, aborted attempt and/or preparatory acts/behavior) on the eC-SSRS
• •15. A history or current evidence of any clinically significant disorder or any other condition which in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results