Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Baclofen IR · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| IR am | ACTIVE_COMPARATOR | 30 mg, single dose, morning administration (immediate release \[IR\]) |
| ER am | EXPERIMENTAL | 30 mg; single dose; morning administration (extended release \[ER\]) |
| ER pm | EXPERIMENTAL | 30 mg; single dose; evening administration |
| IR pm | ACTIVE_COMPARATOR | 30 mg; single dose; evening administration |
| Name | Type | Description |
|---|---|---|
| Baclofen IR | DRUG | 30 mg; single dose |
| Baclofen ER | DRUG | 30 mg; single dose |
Inclusion Criteria: * Between the ages of 18 and 65 years * Body mass index of 19 to 30 kg/m2 at screening * If subject is female and of childbearing potential, she must agree to use an acceptable method of contraception for the duration of the study Exclusion Criteria: * Pregnancy and/or current...
Baclofen IR is an immediate-release small molecule that Alkermes plc is developing for alcohol dependence. It is an investigational product in Phase 1 clinical development. The program has been studied in a single completed Phase 1 trial conducted in the United States.
Baclofen IR is being developed for alcohol dependence, a psychiatric indication. The clinical work to date has been in healthy adult volunteers rather than in patients with alcohol dependence, so its use in that indication remains investigational.
Baclofen IR targets GABBR1 and GABBR2, the two subunits of the GABA-B receptor, and acts as an agonist at that receptor. This target class places it among GABA-B receptor agonists being evaluated for alcohol dependence.
Alkermes plc, which trades on Nasdaq under the ticker ALKS, is the developer of Baclofen IR. The company is responsible for the Phase 1 program evaluating the immediate-release formulation.
Baclofen IR is in Phase 1 development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.
Baclofen IR has been studied in one completed Phase 1 trial, NCT00802035, titled ALK29-002: A Study of Baclofen Formulations in Healthy Adults. It enrolled 16 healthy adult volunteers of all sexes in the United States and used an active-controlled design.