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NTX/BUP · 1 trial · 1 indication
Toleration to the injection was demonstrated by mild opioid withdrawal symptoms (Clinical Opiate Withdrawal Scale \[COWS\] \</=12 or Subjective Opiate Withdrawal Scale \[SOWS\] \</=10) following VIVITROL administration. The COWS is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal. The SOWS is a 16-item self-report questionnaire designed to measure the severity of opioid withdrawal symptoms. The subject rates the intensity of symptoms using a 5-point scale. The range of SOWS scores is 1-10 (mild); 11-20 (moderate); and 21-30 (severe).
| Arm | Type | Description |
|---|---|---|
| NTX/BUP | EXPERIMENTAL | Oral naltrexone + sublingual buprenorphine |
| NTX/PBO-B | ACTIVE_COMPARATOR | Oral naltrexone + sublingual placebo |
| PBO-N/PBO-B | PLACEBO_COMPARATOR | Oral placebo naltrexone + sublingual placebo buprenorphine |
| Name | Type | Description |
|---|---|---|
| NTX/BUP | DRUG | Daily doses |
| NTX/PBO-B | DRUG | Daily doses |
| PBO-N/PBO-B | DRUG | Daily doses |
Inclusion Criteria: * Willing and able to provide informed consent * Willing and able to provide government-issued identification * Has a BMI of 18.0-40.0 kg/m\^2 * Has a physiologic dependence on opioids * Is voluntarily seeking treatment for opioid use disorder and willing to completely withdraw ...
NTX is an investigational small molecule being developed for Alcohol Use Disorder and Opioid Use Disorder. It is studied as a pharmacotherapy to support harm reduction and treatment in these psychiatric conditions. The drug is in clinical development and has not been approved by the FDA.
NTX is being developed by Alkermes plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALKS. Alkermes is conducting clinical trials to evaluate NTX for the treatment of Alcohol Use Disorder and Opioid Use Disorder.
NTX is in Phase 2 and Phase 3 clinical development. One completed Phase 2 trial evaluated NTX for Alcohol Use Disorder, and two completed Phase 3 trials assessed it for Opioid Use Disorder. The drug remains investigational and is not yet approved.
NTX has been studied in three completed clinical trials. NCT01932801 was a Phase 2 trial for Alcohol Use Disorder with 308 participants. NCT02110264 and NCT02537574 were Phase 3 trials for Opioid Use Disorder, with 151 and 380 participants respectively. All trials were conducted in the United States.
NTX is a form of naltrexone, an opioid antagonist. One trial, NCT02537574, evaluated naltrexone for use with buprenorphine in adults with Opioid Use Disorder prior to the first dose of VIVITROL, which is naltrexone for extended-release injectable suspension. NTX is being developed by Alkermes.