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 investigational small molecule being developed for alcohol dependence. It is currently in Phase 1 clinical development. The drug is being studied in healthy adults to evaluate its effects, though it is not yet approved for any use.
Baclofen IR is being developed by Alkermes plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALKS. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy volunteers.
Baclofen IR is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing development is focused on assessing the drug's properties in early-stage trials.
Baclofen IR has one completed clinical trial registered as NCT00802035, titled "ALK29-002: A Study of Baclofen Formulations in Healthy Adults." This Phase 1 study enrolled 16 participants in the United States and was an active-controlled trial, though it was not randomized or double-blinded.
Baclofen IR is a specific formulation of baclofen, a drug that has been used for other conditions. In this context, it is being developed as an immediate-release formulation for alcohol dependence. The clinical trial NCT00802035 evaluated baclofen formulations in healthy adults.