OZOBAX

Peak

baclofen

NDAORALSOLUTION
Approved
Sep 2019
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)

NCT03058237Phase 1Completed

A Phase 1 Bioavailability Study of Arbaclofen Placarbil Modified Release Formulations in Healthy Volunteers

Started Jan 2017
40 enrolled
Healthy Volunteers
NCT02511886Phase 2Completed

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
NCT01051128Phase 3Withdrawn

Continuous Intrathecal Baclofen Infusion for Chronic Spasticity

Started Jan 2010
0
Spasticity
NCT00802035Phase 1Completed

ALK29-002: A Study of Baclofen Formulations in Healthy Adults

Started Nov 2008
16 enrolled
Alcohol Dependence
NCT00516503Phase 3Completed

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
Aug 30, 2039
164 months away
Patent Expiry
Aug 30, 2039

Patent Records (1)

Patent #ExpiryTypeUse Code
10610502
Aug 30, 2039
U-2779