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Also known as ALKS 37
ALKS 33 · 3 trials · 3 indications
Overall response will be defined using an algorithm that takes into consideration number of complete spontaneous bowel movements, improvement from baseline, and durability of response.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Capsules for oral administration |
| ALKS 37 | EXPERIMENTAL | Capsules for oral administration |
| ALKS33 (RDC-0313) (1 mg) | EXPERIMENTAL | 1 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration |
| ALKS33 (RDC-0313) (2.5 mg) | EXPERIMENTAL | 2.5 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration |
| ALKS33 (RDC-0313) (10 mg) | EXPERIMENTAL | 10 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration |
| Name | Type | Description |
|---|---|---|
| ALKS 37 | DRUG | Capsules for oral administration |
| Placebo | DRUG | Capsules for oral administration |
| ALKS33 (RDC-0313) (1 mg) | DRUG | 1 mg ALKS33 (RDC-0313) taken once daily for 12 weeks |
| ALKS33 (RDC-0313) (2.5 mg) | DRUG | 2.5 mg ALKS33 (RDC-0313) taken once daily for 12 weeks |
| ALKS33 (RDC-0313) (10 mg) | DRUG | 10 mg ALKS33 (RDC-0313) taken once daily for 12 weeks |
Inclusion Criteria: * Are at least 18 years of age at time of consent * Have a body mass index (BMI)of 19 to 35 kg/m2 at screening * Are receiving prescribed opioid medication for the management of chronic, non-cancer pain * Meet the criteria of OIC * Agree to use an acceptable method of contracept...
ALKS 33 has been studied in clinical trials for alcohol dependence and for opioid-induced constipation, also called OIC. The alcohol dependence program was evaluated in adults, and the OIC program was evaluated in adults with opioid-induced constipation. ALKS 33 is an investigational small molecule that has not been approved for any indication.
ALKS 33 is being developed by Alkermes plc, which trades on the Nasdaq under the ticker ALKS. Alkermes sponsored the Phase 2 clinical trials of ALKS 33 in alcohol dependence and opioid-induced constipation. The drug remains an investigational asset in the company's pipeline.
ALKS 33 is in Phase 2 development. Three Phase 2 trials have been completed, one in alcohol dependence and two in opioid-induced constipation. No active trials are currently listed for ALKS 33, and the drug has not been approved by the FDA for any indication.
ALKS 33 has been evaluated in three completed Phase 2 trials. NCT00981617 studied ALKS33 (RDC-0313) in adults with alcohol dependence and enrolled 406 participants. NCT01382797 and NCT01418092 studied ALKS 37 (RDC-1036) in adults with opioid-induced constipation and enrolled 157 and 91 participants, respectively.
ALKS 33 is also known as ALKS33 (RDC-0313) (1 mg), ALKS33, and ALKS 37. The alcohol dependence trial used the ALKS33 (RDC-0313) designation, while the opioid-induced constipation trials used the ALKS 37 (RDC-1036) designation. These names refer to the same Alkermes development program.