NDAORALGRANULES
Approved
Nov 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
9
Mechanism of Action
GABA A Agonists
Pharmacologic Class:
gamma-Aminobutyric Acid-ergic Agonist
Clinical Trials (5)
A Phase 1 Bioavailability Study of Arbaclofen Placarbil Modified Release Formulations in Healthy Volunteers
Started Jan 2017
40 enrolled
Healthy Volunteers
A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder
Started Sep 2015
18 enrolled
Alcohol Use Disorder
Continuous Intrathecal Baclofen Infusion for Chronic Spasticity
Started Jan 2010
0Spasticity
ALK29-002: A Study of Baclofen Formulations in Healthy Adults
Started Nov 2008
16 enrolled
Alcohol Dependence
Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
Started Feb 2008
208 enrolled
Chronic Myeloproliferative DisordersLeukemiaLymphoma+7 more
Loss of Exclusivity
LOE Date
Sep 29, 2041
189 months away
Patent Expiry
Sep 29, 2041