Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Treatment with naltrexone for extended-release injectable suspension should be part of a comprehensive management program that includes psychosocial support. Naltrexone for extended-release injectable suspension contains naltrexone, an opioid antagonist, and is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment… FDA label
Also known as VIVITROL (Naltrexone extended-release injectable suspension), Extended-Release Naltrexone, XR-NTX, long-acting naltrexone
VIVITROL · 3 trials · 3 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).
Percentage of subjects with no cocaine use for at least 3 weeks
Percentage of participants who were abstinent from drinking
| 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. |
| 1 | EXPERIMENTAL | VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6 |
| 2 | PLACEBO_COMPARATOR | Placebo injection, 380 mg injection at the start of weeks 2 and 6. |
| 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. |
| VIVITROL (Naltrexone extended-release injectable suspension) | DRUG | VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6. |
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 to treat alcohol dependence, opioid dependence, and cocaine dependence. It is an extended-release injectable suspension of naltrexone, developed by Alkermes plc (ticker ALKS). The drug is a small molecule in the psychiatry therapeutic area and has been studied in placebo-controlled, double-blind, randomized clinical trials.
VIVITROL is also known as naltrexone extended-release injectable suspension, VIVITROL 380 mg, and VIVITROL 380 mg. These names refer to the same product: a long-acting injectable formulation of naltrexone developed by Alkermes plc under the ticker ALKS.
VIVITROL is made by Alkermes plc, which trades under the ticker ALKS. Alkermes developed the extended-release injectable suspension formulation of naltrexone for the treatment of alcohol dependence, opioid dependence, and cocaine dependence.
VIVITROL has been studied in Phase 3 clinical trials. The Phase 3 program includes trials such as ALK21-013 in adults with opioid dependence and ALK21-014 in alcohol dependence. The drug is an extended-release injectable suspension of naltrexone developed by Alkermes plc.
VIVITROL has been evaluated in completed clinical trials including NCT00777062, a Phase 2 study of VIVITROL as a treatment for cocaine and alcohol dependence; NCT00678418, a Phase 3 trial in adults with opioid dependence; and NCT00501631, a Phase 3 trial in alcohol dependence after enforced abstinence.