XYREM

Peak

sodium oxybate

NDAORALSOLUTIONPriority Review
Approved
Jul 2002
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

depressant. The mechanism of action of Sodium Oxybate Oral Solution in the treatment of narcolepsy is unknown. Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB), an endogenous compound and metabolite of the neurotransmitter GABA. It is hypothesized that the therapeutic effects of…

Clinical Trials (5)

NCT05869773Phase 4Completed

A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy

Started Jun 2023
160 enrolled
Narcolepsy
NCT04006925Phase 4Completed

Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate

Started Sep 2019
24 enrolled
REM Sleep Behavior DisorderParkinson Disease
NCT02221869Phase 3Completed

A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy

Started Oct 2014
106 enrolled
Narcolepsy With Cataplexy
NCT01584934Phase 4Withdrawn

Sodium Oxybate in Patients With Chronic Fatigue Syndrome.

Started Jun 2013
0
Chronic Fatigue Syndrome
NCT00803023Phase 3Completed

Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia

Started Mar 2010
129 enrolled
Fibromyalgia

Loss of Exclusivity

LOE Date
Sep 15, 2033
91 months away
Patent Expiry
Sep 15, 2033
Exclusivity Expiry
Apr 26, 2026

Patent Records (5)

Patent #ExpiryTypeUse Code
10213400
Mar 15, 2033
U-2499
10864181
Mar 15, 2033
U-1532
11253494
Mar 15, 2033
U-3324
11986446
Mar 15, 2033
U-3324
8772306
Mar 15, 2033
U-1532