Special Episode: FDA Approves Sodium Oxybate for Pediatric Narcolepsy
Oct 23, 09:00 PM
Welcome to this special episode of the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. For major FDA decisions in the field of neurology, we release short special episodes to offer a snapshot of the news, including the main takeaways for the clinical community, as well as highlights of the efficacy and safety profile of the agent in question.
In this episode, we cover the recent approval of Avadel's sodium oxybate formulation (Lumryz) as a treatment for pediatric patients with narcolepsy aged 7 years and older. The new indication expands on its previous one, granted in May 2023, which included the the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. It's initial approval was based on data from the phase 3 REST-ON trial (NCT02720744), a large-scale study in which the therapy met all 3 of its primary end points of change from baseline in mean sleep latency on the Maintenance of Wakefulness test, Clinical Global Impression Improvement, and weekly cataplexy attacks. Following its new indication, NeurologyLive sat down with Anne Marie Morse, DO, FAASM, a pediatric sleep disorders expert, to discuss the significance of the new approval. Morse, director of Child Neurology and Pediatric Sleep Medicine at Geisinger Janet Weis Children's Hospital as well as the program director for Child Neurology Residency Program, provided commentary on the clinical considerations behind this once-nightly formulation of sodium oxybate, and how it should be used going forward.
In this episode, we cover the recent approval of Avadel's sodium oxybate formulation (Lumryz) as a treatment for pediatric patients with narcolepsy aged 7 years and older. The new indication expands on its previous one, granted in May 2023, which included the the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. It's initial approval was based on data from the phase 3 REST-ON trial (NCT02720744), a large-scale study in which the therapy met all 3 of its primary end points of change from baseline in mean sleep latency on the Maintenance of Wakefulness test, Clinical Global Impression Improvement, and weekly cataplexy attacks. Following its new indication, NeurologyLive sat down with Anne Marie Morse, DO, FAASM, a pediatric sleep disorders expert, to discuss the significance of the new approval. Morse, director of Child Neurology and Pediatric Sleep Medicine at Geisinger Janet Weis Children's Hospital as well as the program director for Child Neurology Residency Program, provided commentary on the clinical considerations behind this once-nightly formulation of sodium oxybate, and how it should be used going forward.
For more of NeurologyLive's coverage of sodium oxybate's (Lumryz) expanded indication, head here: FDA Approves Avadel's Sodium Oxybate for Cataplexy or Excessive Daytime Sleepiness in Pedatric Narcolepsy
Episode Breakdown:
- 2:10 – Immediate reaction and significance
- 4:10 – Considerations and caution with prescribing sodium oxybate
- 8:20 – Closing remarks and the need to utilize highly effective treatments for narcolepsy
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