Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as naltrexone for extended-release injectable suspension
Medisorb naltrexone · 6 trials · 3 indications
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration in this extension through the end of the follow-up period).
A TEAE was defined as any adverse event (AE) that started or worsened on or after the administration of the first dose of study medication through 30 days after the end of study treatment.
A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
Drinking rates were assessed from participants' self-reports using the validated Timeline Follow-Back (TLFB) method. Using a TLFB calendar, participants reported the number of days they had consumed alcohol along with the amount they consumed on each day. A heavy drinking day was defined as ≥5 drinks/day for men and ≥4 drinks/day for women.
Photographs of subjects' pupils were measured horizontally and vertically, 15 minutes before the first hydromorphone dose and every 15 minutes after each hydromorphone/placebo for hydromorphone dose, for up to 1 hour. Size was the product of vertical and horizontal measures. The slope, determined by linear regression, was used as a summary measure of the dose-response relationship between the hydromorphone dose and pupil size. The steeper the slope, the greater the hydromorphone effect. A slope of zero indicated no evidence of a hydromorphone effect.
| Arm | Type | Description |
|---|---|---|
| Medisorb naltrexone 380 mg (VIVITROL) | EXPERIMENTAL | - |
| Medisorb naltrexone 380 mg | EXPERIMENTAL | - |
| Medisorb naltrexone 190 mg | EXPERIMENTAL | - |
| Oral naltrexone 50 mg | ACTIVE_COMPARATOR | - |
| Placebo for Medisorb naltrexone 190 mg | PLACEBO_COMPARATOR | - |
| Placebo for Medisorb naltrexone 380 mg | PLACEBO_COMPARATOR | - |
| Medisorb naltrexone 75 mg | EXPERIMENTAL | - |
| Medisorb naltrexone 150 mg | EXPERIMENTAL | - |
| Medisorb naltrexone 300 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Medisorb naltrexone 380 mg | DRUG | Intramuscular (IM) injection administered once every 4 weeks for up to 2 years |
| Medisorb naltrexone 190 mg | DRUG | Administered via IM injection once every 4 weeks for up to 3.5 years. |
| Oral naltrexone 50 mg | DRUG | Tablet taken orally once daily for up to 1 year |
| Placebo matching Medisorb naltrexone 190 mg | DRUG | IM injection once every 4 weeks for a total of 6 administrations. |
| Placebo matching Medisorb naltrexone 380 mg | DRUG | IM injection once every 4 weeks for a total of 6 administrations. |
| Medisorb naltrexone 75 mg | DRUG | Single administration via intramuscular (IM) injection. |
| Medisorb naltrexone 150 mg | DRUG | Single administration via IM injection. |
| Medisorb naltrexone 300 mg | DRUG | Single administration via IM injection. |
| Hydromorphone (10 mg/mL) | DRUG | Increasing doses of 0, 3, 4.5, and 6 mg were administered at baseline (pre-study drug administration). After study drug administration, additional hydromorphone challenge sessions consisting of administering 0, 3, 4.5, and 6 mg were administered at 1-hr intervals at each of the postdose evaluation visits. In addition, at a randomly selected evaluation visit, subjects received four 0 mg (placebo) doses at 1-hour intervals. |
| Naloxone Challenge and Oral Naltrexone Tolerability Testing | DRUG | Administered according to the instructions provided by the respective manufacturer. Testing occurred at least 7 days after the baseline hydromorphone challenge and prior to study drug administration. |
Primary Inclusion Criteria: * Health care professional (eg, physician, osteopath, nurse, pharmacist) * 18 years of age or older * Enrolled or enrolling in an extended outpatient treatment program for opioid dependence * Women of childbearing potential must agree to use an approved method of contrac...
Medisorb naltrexone is an injectable, long-acting formulation of naltrexone developed by Alkermes plc under the ticker ALKS. It is a small molecule studied in Phase 3 clinical development for alcohol dependence, alcoholism, and opiate dependence. The formulation uses the Medisorb drug delivery technology to provide extended-release dosing.
Medisorb naltrexone has been studied for the treatment of alcohol dependence, alcoholism, and opiate dependence. Clinical trials enrolled adults with these conditions, including a Phase 3 study in alcohol-dependent adults and a Phase 2 opiate challenge study in adults who use opioids. It is an investigational product in Phase 3 development.
Medisorb naltrexone is developed by Alkermes plc, which trades under the ticker ALKS. Alkermes conducted the clinical development program, including the ALK21-003, ALK21-003EXT, ALK21-004, and ALK21-006 studies of the long-acting injectable formulation.
Medisorb naltrexone is in Phase 3 clinical development. Its trial program includes Phase 3 studies in alcohol dependence and alcoholism as well as a Phase 2 opiate challenge study. The program has completed three trials with a combined enrollment of 1,168 participants, and no trials are currently active.
Medisorb naltrexone has been evaluated in completed trials including NCT01218997 (ALK21-006), a Phase 3 long-term study in alcoholism with 436 participants; NCT01218971 (ALK21-003EXT), a Phase 3 long-term safety extension in alcohol dependence with 332 participants; and NCT01218958 (ALK21-003), a Phase 3 study in alcohol-dependent adults with 624 participants.