Lumryz Approval Expanded to Include Pediatric Narcolepsy

The Food and Drug Administration (FDA) has expanded the approval of Lumryz™ (sodium oxybate) extended-release oral suspension to include treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Previously the treatment had only been approved for adults.

Lumryz is an extended-release formulation of sodium oxybate, a central nervous system (CNS) depressant. Its therapeutic effects are believed to be mediated through GABA_B actions at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons. 

The pediatric approval was supported by data from a clinical study in patients treated with immediate-release sodium oxybate (ClinicalTrials.gov Identifier: NCT02221869). The study, which included patients aged 7 to 17 years with narcolepsy, established the effectiveness of immediate-release sodium oxybate in the treatment of cataplexy or EDS in this patient population. The most common adverse reactions reported in pediatric patients included nausea, enuresis, vomiting, headache, decreased weight, decreased appetite, dizziness, and sleepwalking.

“With this label expansion, pediatric patients 7 years and older living with narcolepsy now have the same option that adult patients with narcolepsy have – to choose a once-nightly treatment option that does not disrupt sleep for a middle of the night dose,” said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals.

Lumryz, a Schedule III controlled substance, is available only through a restricted program called the Lumryz REMS because of the risks of CNS depression and the potential for abuse and misuse. Prescribers and pharmacies must be certified in order to prescribe and dispense Lumryz. Additionally, patients must be enrolled in the program in order to receive the medication.

Lumryz is supplied in packets with granules that are mixed with water to create an oral suspension; the carton contains a mixing cup. The dosage strengths include 4.5 g, 6 g, 7.5 g, and 9 g of sodium oxybate per packet. The product is taken orally as a single dose at bedtime. 

For pediatric patients, the dosage, titration regimen, and maximum total nightly dosage are based on patient weight. For patients weighing less than 45 kg, the recommended starting dosage of Lumryz cannot be achieved with the available strengths, therefore another sodium oxybate product should be used to initiate treatment. 

This article originally appeared on MPR