Lumryz FDA Approval History
Last updated by Judith Stewart, BPharm on May 2, 2023.
FDA Approved: Yes (First approved May 1, 2023)
Brand name: Lumryz
Generic name: sodium oxybate
Dosage form: Granules for Extended-Release Oral Suspension
Company: Avadel Pharmaceuticals plc
Treatment for: Narcolepsy
Lumryz (sodium oxybate) is a once-nightly formulation of the approved central nervous system depressant sodium oxybate indicated for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.
- Narcolepsy is a chronic neurological disorder that affects the brain's ability to control sleep-wake cycles. Symptoms of narcolepsy include excessive daytime sleepiness, characterized by persistent sleepiness where an overwhelming sense of sleepiness comes on quickly, and cataplexy, characterized by a sudden loss of muscle tone while a person is awake that leads to weakness and a loss of voluntary muscle control.
- Lumryz contains the CNS depressant drug sodium oxybate, the sodium salt of gamma hydroxybutyrate (GHB) which is thought to work in the treatment of narcolepsy through GABAB actions at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons.
- Sodium oxybate was first approved in an oral solution formulation under the brand name Xyrem in 2002. Xyrem is administered in two doses at night - the first dose at bedtime (two hours after eating) and the second dose 2.5 to 4 hours later.
- Lumryz is an extended-release formulation of sodium oxybate administered once at night, two hours after eating.
- Lumryz is a Schedule III controlled substance. The product label for Lumryz carries a Boxed Warning for central nervous system depression, and abuse and misuse. Lumryz is available only through a restricted program called the Lumryz REMS.
- Warnings and precautions associated with Lumryz include central nervous system depression; depression and suicidality; confusion/anxiety; and disruptive sleep-related disorders. Lumryz also has a high sodium content.
- Common adverse reactions include nausea, dizziness, enuresis, headache, and vomiting.
Development timeline for Lumryz
Further information
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