What is the mechanism of action of this treatment?

The most common treatments for narcolepsy, such as sodium oxybate and its low-sodium variant XYWAV, work primarily by modulating neurotransmitter activity in the brain. Sodium oxybate, the sodium salt of gamma-hydroxybutyrate (GHB), enhances slow-wave sleep and reduces symptoms of excessive daytime sleepiness (EDS) and cataplexy by acting on gamma-aminobutyric acid (GABA) type B receptors. This modulation helps stabilize sleep architecture and improve overall sleep quality. The low-sodium formulation, XYWAV, offers similar benefits while reducing sodium intake, which can be particularly important for patients concerned about blood pressure and cardiovascular health. Effective management of these symptoms is crucial for improving the quality of life and daily functioning of narcolepsy patients.

What side effects are associated with this type of intervention?

Common treatments for narcolepsy, such as sodium oxybate, can cause side effects including nausea, dizziness, headache, and enuresis. High-sodium oxybate may increase blood pressure due to its sodium content. XYWAV, a low-sodium oxybate, aims to reduce sodium intake and potentially lower blood pressure. Other treatments like modafinil and pitolisant can cause headaches, nausea, and anxiety. Antidepressants used for cataplexy, such as venlafaxine and fluoxetine, may cause dry mouth, insomnia, and sexual dysfunction.

What prior FDA approvals exist?

The FDA has approved several treatments for narcolepsy, including sodium oxybate (Xyrem) and its low-sodium formulation, XYWAV. Sodium oxybate has been shown to be effective in reducing cataplexy attacks and excessive daytime sleepiness. XYWAV, a newer formulation with lower sodium content, aims to provide similar benefits while potentially reducing the risk of high blood pressure associated with high sodium intake. Other FDA-approved treatments for narcolepsy include modafinil and armodafinil, which are wake-promoting agents, and solriamfetol, which is used to improve wakefulness in adults with narcolepsy.

What other types of research exist?

Promising novel alternatives to XYWAV for narcolepsy patients in 2024 may include orexin receptor antagonists, which are being studied for their potential to regulate sleep-wake cycles. Additionally, advancements in cannabinoid-based therapies, such as dronabinol, are being investigated for their effects on sleep disorders and may offer new treatment options. Patients should discuss these emerging therapies with their healthcare providers to determine the best course of action.

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Sodium Oxybate

Low-Sodium Oxybate for Narcolepsy

Phase 4

Recruiting

Research Sponsored by Jazz Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new version of a narcolepsy medication with less salt. It aims to see if this change lowers blood pressure in people with narcolepsy who are currently using a high-sodium version. A lower sodium version of this medication is approved for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy as young as seven years old.

Who is the study for?

Adults aged 18-70 with narcolepsy, currently treated with high-sodium oxybate and stable doses of any blood pressure or wakefulness medications for at least 6 weeks prior to the study. Participants must not be pregnant, breastfeeding, have unstable medical conditions, significant cardiovascular disease, or psychiatric disorders that could impact their safety or study results.

What is being tested?

The trial is testing the effect on blood pressure when switching from high-sodium oxybate (XYREM) to a low-sodium version called XYWAV in people with narcolepsy. The goal is to see if reducing sodium intake through medication changes can improve blood pressure.

What are the potential side effects?

While specific side effects are not listed here, participants may experience changes related to lower sodium levels and adjustments in sleep patterns due to the switch from one medication (high-sodium oxybate) to another (low-sodium XYWAV).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: JZP258Experimental Treatment1 Intervention

Participants will receive 6 to 9 grams per night of JZP258 (XYWAV) for 6 consecutive weeks.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for narcolepsy, such as sodium oxybate and its low-sodium variant XYWAV, work primarily by modulating neurotransmitter activity in the brain. Sodium oxybate, the sodium salt of gamma-hydroxybutyrate (GHB), enhances slow-wave sleep and reduces symptoms of excessive daytime sleepiness (EDS) and cataplexy by acting on gamma-aminobutyric acid (GABA) type B receptors. This modulation helps stabilize sleep architecture and improve overall sleep quality. The low-sodium formulation, XYWAV, offers similar benefits while reducing sodium intake, which can be particularly important for patients concerned about blood pressure and cardiovascular health. Effective management of these symptoms is crucial for improving the quality of life and daily functioning of narcolepsy patients.

Treatment paradigms for cataplexy in narcolepsy: past, present, and future.Recent advances in the treatment of narcolepsy.