Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Arbaclofen Placarbil SR
Arbaclofen Placarbil · 1 trial · 1 indication
A data monitoring committee (DMC) will review and make a recommendation to stop dosing escalation based on the review of the unblinded AE and safety assessments or when at least one subject on active investigational product experiences an SAE related to the investigational product. The MTD and the dosage that will not be exceeded in the further development of this compound will be based upon a comprehensive review of the safety data.
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Apparent terminal rate constant (1/h), determined by linear regression of the terminal points of the log-linear concentration-time curve. Visual assessment will be used to identify the terminal linear phase of the concentration-time profile. A minimum of 3 data points will be used for determination.
If the extrapolated area is greater than 20% of AUCinf, then AUCinf will be listed but not included in summary presentations or statistical analyses
Calculated as Dose/AUCinf
Calculated as Dose/apparent terminal phase rate constant \* AUCinf
Area Under the Plasma Concentration-Time Curve From Time 0 to the End of the Dosing Interval
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
| Arm | Type | Description |
|---|---|---|
| Arbaclofen Placarbil (AP) | EXPERIMENTAL | Orally administered Arbaclofen Placarbil (AP) sustained release (SR) tablets |
| Placebo | PLACEBO_COMPARATOR | Subjects remain on placebo for entire study |
| Name | Type | Description |
|---|---|---|
| Arbaclofen Placarbil | DRUG | Arbaclofen Placarbil |
| Placebo | DRUG | Placebo matched tablets |
Inclusion Criteria: 1. 18 to 65 years of age. 2. Diagnosis of AUD confirmed by the Mini-International Neuropsychiatric Interview. 3. For those requiring medical detoxification from alcohol, subjects will be required to have completed a program for detoxification from alcohol within 4 days prior to ...
Arbaclofen Placarbil is an investigational small-molecule drug developed by Supernus Pharmaceuticals for Alcohol Use Disorder. It is a Phase 2 candidate in the psychiatry therapeutic area. It has also been referred to as Arbaclofen Placarbil SR. It is not an approved medicine and remains in clinical development.
Arbaclofen Placarbil is being studied as a treatment for Alcohol Use Disorder, a psychiatric condition. Its clinical development has focused on this indication, including a Phase 2 dose-escalation study in adults with Alcohol Use Disorder. It is investigational and has not been established as a therapy for this condition.
Arbaclofen Placarbil targets GABBR1 and GABBR2, the subunits of the GABA-B receptor, and acts as an agonist at this receptor. Agonist activity at the GABA-B receptor is the mechanism described for this small molecule. The drug is being developed in Alcohol Use Disorder on the basis of this target class.
Arbaclofen Placarbil is developed by Supernus Pharmaceuticals, Inc., which trades under the ticker SUPN. Supernus is the company associated with the clinical program for this small-molecule candidate in Alcohol Use Disorder. The compound is also referred to as Arbaclofen Placarbil SR.
Arbaclofen Placarbil is in Phase 2 development. Its clinical program in Alcohol Use Disorder consists of one completed Phase 2 trial, and no trials are currently active. The drug is investigational and is not approved for marketing in the United States.
Arbaclofen Placarbil has been studied in one completed Phase 2 trial, NCT02511886, a dose-escalation study to determine the maximum tolerated dose in subjects with Alcohol Use Disorder. The trial enrolled 18 participants in the United States, was randomized, double-blind, and placebo-controlled, and included adults 18 years and older.
Yes, Arbaclofen Placarbil SR is another name for Arbaclofen Placarbil, the investigational small-molecule GABA-B receptor agonist developed by Supernus Pharmaceuticals for Alcohol Use Disorder. Readers searching either name are looking at the same Phase 2 drug candidate under development by Supernus.