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Also known as Subutex
Buprenorphine soluble film · 1 trial · 1 indication
The COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the response to each of the 11 items and cover a range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal. The baseline COWS was the score obtained 30 minutes prior to administration of soluble films on Day 1. Peak COWS was the highest COWS score obtained between 1-23.5 hours post administration on Day 1.
| Arm | Type | Description |
|---|---|---|
| Buprenorphine soluble film | EXPERIMENTAL | Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours. Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours. |
| Buprenorphine/naloxone soluble film | EXPERIMENTAL | Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours. Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours. |
| Name | Type | Description |
|---|---|---|
| Buprenorphine soluble film | DRUG | Buprenorphine soluble film strips administered sublingually with doses escalated from 12 mg per day up to 24 mg daily for 5 days of total treatment. |
| Buprenorphine/naloxone film strip | DRUG | Buprenorphine/naloxone soluble film strips administered sublingually with doses escalated from 12 mg buprenorphine/3 mg naloxone to 24 mg buprenorphine /6 mg naloxone daily for 5 days of total treatment. |
| Placebo | DRUG | Placebo soluble film administered on the same schedule as active treatment to maintain the study blind. |
Inclusion Criteria: Subject must: * Provide written informed consent. * Have a Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of opioid dependence. * Be male or female, 18 to 65 years of age, inclusive. * If female, have a negative pregnancy test during screening and a...
Buprenorphine soluble film is being developed for opioid-related disorders. It is a small molecule in Phase 2 clinical development under Indivior Pharmaceuticals, Inc. (ticker INDV). The film formulation is designed to dissolve for administration in the treatment of opioid dependence.
Buprenorphine soluble film targets OPRK1 and OPRM1, the kappa and mu opioid receptors, as an agonist. By acting at these receptors, it is intended to address opioid-related disorders. This mechanism is consistent with buprenorphine's known activity as a partial mu agonist and kappa antagonist.
Indivior Pharmaceuticals, Inc. (ticker INDV) is the developer of buprenorphine soluble film. The company is advancing this small molecule formulation for opioid-related disorders.
Buprenorphine soluble film is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The program has completed one Phase 2 trial.
Buprenorphine soluble film has been studied in one completed Phase 2 trial, NCT00637000, titled Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone. The trial enrolled 38 participants in the United States, was randomized, double-blind, and controlled, and included adults aged 18 years and older of all sexes.