Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 used for the treatment of alcohol dependence, alcoholism, and opiate dependence. It is a small molecule developed by Alkermes plc for psychiatric conditions. The drug is being studied in clinical trials to address these substance use disorders.
Medisorb naltrexone is an opioid antagonist that works by blocking the effects of opioids on the brain. It targets opioid receptors to reduce the rewarding effects of alcohol and opioids, thereby helping to decrease cravings and support abstinence in individuals with alcohol or opiate dependence.
Medisorb naltrexone is developed by Alkermes plc, a biopharmaceutical company. Alkermes is responsible for the clinical development and potential commercialization of this drug for alcohol and opiate dependence indications.
Medisorb naltrexone is in Phase 3 clinical development. It has completed multiple Phase 3 trials, including studies in alcohol-dependent adults and long-term safety studies. The drug is investigational and not yet approved by regulatory authorities.
Medisorb naltrexone has completed three clinical trials. NCT00834080 was a Phase 3 safety study in healthcare professionals with opiate dependence. NCT01218958 was a Phase 3 study in alcohol-dependent adults. NCT01218984 was a Phase 2 single-dose opiate challenge study in adults who use opioids.
Yes, Medisorb naltrexone is the same as VIVITROL. The clinical trials listed for Medisorb naltrexone refer to it as Medisorb Naltrexone (VIVITROL), indicating that VIVITROL is the brand name for this extended-release formulation of naltrexone.