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General Information
Lumryz is specifically indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
Lumryz is supplied as an extended-release oral suspension.
Lumryz is taken orally as a single dose at bedtime. Prepare the dose of Lumryz prior to bedtime. Prior to ingestion, the dose of Lumryz should be suspended in approximately 1/3 cup (approximately 80 mL) of water in the mixing cup provided. Do not use hot water. After mixing, consume Lumryz within 30 minutes. Take Lumryz at least 2 hours after eating.
The recommended starting dosage is 4.5 grams (g) once per night administered orally. Increase the dosage by 1.5 g per night at weekly intervals to the recommended dosage range of 6 g to 9 g once per night orally. The dosage may be gradually titrated based on efficacy and tolerability. Doses higher than 9 g per night have not been studied and should not ordinarily be administered.
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 therapeutic effects of Lumryz on cataplexy and excessive daytime sleepiness are mediated through GABAB actions at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons.
Side Effects
Adverse effects associated with the use of Lumryz may include, but are not limited to, the following:
- nausea
- dizziness
- enuresis
- headache
- vomiting
The Lumryz drug label comes with the following Black Box Warning: Central Nervous System Depression: Lumryz is a CNS depressant, and respiratory depression can occur with Lumryz use. Abuse and Misuse: Lumryz is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB is associated with CNS adverse reactions, including seizure, respiratory depression, decreased consciousness, coma, and death. Lumryz is available only through a restricted program called REMS.
Clinical Trial Results
The FDA approval of Lumryz was based on results from the pivotal Phase 3 REST-ON clinical study. In the trial, once-at-bedtime Lumryz demonstrated highly statistically significant and clinically meaningful improvement compared to placebo across all three co-primary endpoints (Maintenance of Wakefulness Test, Clinical Global Impression-Improvement and mean weekly cataplexy attacks) for all three doses evaluated, 6, 7.5 and 9 grams.