Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VIVITROL · 2 trials · 2 indications
Included are data from the last 20 weeks of the 24-week double-blind treatment period (Part A). Response profiles for each Arm are based on subjects' individual rates of weekly opioid-free data, including negative urine test results, attendance at study visits, and self-reports of opioid use/non-use.
Cumulative percentage (%) of subjects reporting heavy drinking by category reflecting the various cut-offs for percentage of days that were heavy drinking days. A "heavy drinking day" was defined as 4 or more alcohol drinks in 1 day for women, and 5 or more alcohol drinks in 1 day for men. The Timeline Follow-Back (TLFB) method (Sobell \& Sobell: Humana Press, 1992) was utilized to collect subjects' daily drinking information (ie, the number of drinks consumed per day per subject which was retrospectively recalled and recorded in a diary).
| Arm | Type | Description |
|---|---|---|
| VIVITROL® 380 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| VIVITROL 380 mg | ACTIVE_COMPARATOR | Administered via intramuscular (IM) injection once every 4 weeks. |
| Placebo for VIVITROL 380 mg | PLACEBO_COMPARATOR | Administered via IM injection once every 4 weeks. |
| Name | Type | Description |
|---|---|---|
| VIVITROL® 380 mg | DRUG | Administered via intramuscular (IM) injection once every 4 weeks for 24 weeks during Part A, followed by once every 4 weeks for 52 weeks in Part B. |
| Placebo | DRUG | Administered via IM injection once every 4 weeks for 24 weeks during Part A, followed by VIVITROL® 380 mg via IM injection once every 4 weeks for 52 weeks in Part B. |
| VIVITROL 380 mg | DRUG | Administered via IM injection once every 4 weeks. |
| Placebo for VIVITROL 380 mg | DRUG | Administered via IM injection once every 4 weeks. |
Primary Inclusion Criteria: * Written, informed consent * 18 years of age or older * Current diagnosis of opioid dependence, based on Diagnostic and Statistical Manual of Mental Health Disorders, 4th Ed. (DSM-IV-TR) criteria * Voluntarily seeking treatment for opioid dependence * Completing or rece...
VIVITROL is used for alcohol dependence and opiate dependence. It is a small molecule being developed by Alkermes plc for these psychiatric conditions. The drug is currently in Phase 3 clinical development and is considered investigational, meaning it has not yet been approved by regulatory authorities.
VIVITROL is a small molecule that contains naltrexone, an opioid antagonist. It works by blocking the effects of opioids and reducing alcohol cravings. The drug is being studied for its efficacy in treating alcohol dependence and opiate dependence in adult patients.
VIVITROL is being developed by Alkermes plc, a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of VIVITROL for alcohol dependence and opiate dependence. Alkermes plc is publicly traded under the ticker symbol ALKS.
VIVITROL is in Phase 3 clinical development. It has completed two Phase 3 trials, one for alcohol dependence and one for opiate dependence. The drug is not yet approved and remains investigational, with ongoing research to support potential regulatory submissions.
VIVITROL has completed two Phase 3 clinical trials. The first, NCT00501631, evaluated the efficacy and safety of VIVITROL after enforced abstinence in 300 adults with alcohol dependence. The second, NCT00678418, assessed its efficacy and safety in 250 adults with opioid dependence in Russia.
VIVITROL is a brand name for a formulation of naltrexone, an opioid antagonist. It is designed as a long-acting injectable version of naltrexone. While the active ingredient is naltrexone, VIVITROL is a specific extended-release formulation developed by Alkermes plc for treating alcohol and opioid dependence.