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Label indication SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support. FDA label
Also known as Subutex®
Buprenorphine · 1 trial · 1 indication
Bioequivalence based on Buprenorphine Cmax (maximum observed concentration of drug substance in plasma).
Bioequivalence based on Buprenorphine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Bioequivalence based on Buprenorphine AUC0-inf (area under the concentration-time curve from time zero to infinity).
| Arm | Type | Description |
|---|---|---|
| Investigational Test Product | EXPERIMENTAL | Buprenorphine 8 mg Sublingual Tablets |
| Reference Listed Drug | ACTIVE_COMPARATOR | Subutex® 8 mg Sublingual Tablets |
| Name | Type | Description |
|---|---|---|
| Buprenorphine | DRUG | 8 mg Sublingual Tablets |
Inclusion Criteria: * Subject must be a male or non-pregnant, non-breastfeeding female. * Subject must be between 18 and 45 years of age (inclusive). * Subject's Body Mass Index (BMI) must be between 18 and 30 (inclusive), and subject must weigh a minimum of 50 kg (110 lbs). * Female subjects must ...
Buprenorphine is a small molecule drug developed by Teva Pharmaceutical Industries Limited. It acts as an agonist at the OPRK1 and OPRM1 receptors. The specific therapeutic indication for this Teva program is undisclosed, and the compound is in Phase 1 clinical development.
Buprenorphine targets OPRK1 and OPRM1, the kappa and mu opioid receptors, and functions as an agonist at these targets. This receptor activity defines its pharmacological class as an opioid receptor agonist small molecule.
Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA, is the developer of this buprenorphine program. The company is responsible for advancing the asset through clinical development.
Buprenorphine is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for the undisclosed indication being pursued by Teva Pharmaceutical Industries Limited.
Teva's buprenorphine program includes one completed Phase 1 trial, NCT01157169, titled Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions. The trial enrolled 40 healthy adult volunteers in the United States, used an active-controlled, randomized design, and has completed.