LUMRYZ

Growth

sodium oxybate

NDAORALFOR SUSPENSION, EXTENDED RELEASE
Approved
May 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
14

Mechanism of Action

12.1 Mechanism of Action LUMRYZ is a CNS depressant. The mechanism of action of LUMRYZ 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…

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
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
NCT00931164Phase 1/2Completed

Sodium Oxybate in Patients With Alternating Hemiplegia of Childhood (AHC-SO)

Started Aug 2009
6 enrolled
Alternating Hemiplegia of Childhood

Loss of Exclusivity

LOE Date
Mar 16, 2042
195 months away
Patent Expiry
Mar 16, 2042
Exclusivity Expiry
Oct 16, 2031

Patent Records (5)

Patent #ExpiryTypeUse Code
12303478
Jul 21, 2037
U-4189
10736866
Jul 21, 2037
Product
12144793
Jul 21, 2037
Product
12226377
Jul 21, 2037
Product
10272062
Jul 21, 2037
Product