Sodium oxybate

Generic Name
Sodium oxybate
Brand Names
Lumryz, Xyrem, Xywav
Drug Type
Small Molecule
Chemical Formula
C4H7NaO3
CAS Number
502-85-2
Unique Ingredient Identifier
7G33012534
Background

Sodium oxybate (Xyrem) is a central nervous system (CNS) depressant used to treat cataplexy or excessive daytime sleepiness associated with narcolepsy. It is a sodium salt of gamma-Hydroxybutyric acid, an endogenous cerebral inhibitory neurotransmitter and a metabolite of the inhibitory neurotransmitter GABA. Due to its physiological effects, sodium oxybate is associated with a risk for substance misuse and abuse. Sodium oxybate has been misused to stimulate body growth and to induce euphoria, disinhibition, and sexual arousal as a "party drug" or "club drug." For safety reasons, sodium oxybate is a controlled substance only available through a restricted program in approved countries.

An extended-release oral suspension formulation of sodium oxybate for narcolepsy, marketed under the brand name LUMRYZ, gained tentative FDA approval in July 2022 and was fully approved in May 2023. In some countries, sodium oxybate has been investigated and used in alcohol withdrawal syndrome (AWS) to aid abstinence maintenance in alcohol use disorders.

Indication

Sodium oxybate is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy. In the US and in Europe, the drug is approved for use in patients 7 years of age and older while in Canada, it is not recommended in children under the age of 18, unless clearly needed.

Associated Conditions
Cataplexy, Excessive Daytime Sleepiness
Associated Therapies
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Axsome Therapeutics eyes approval after Phase III narcolepsy win

Axsome Therapeutics' AXS-12 met primary endpoint in Phase III ENCORE trial, reducing cataplexy attacks by 72% at one month and 82% at six months. The company plans to submit an NDA to the FDA.
globenewswire.com
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Avadel Pharmaceuticals Provides Corporate Update

Avadel Pharmaceuticals reports $50 million in LUMRYZ revenue, 2,300 patients on the drug, and FDA approval for pediatric use. The company also secured a court ruling affirming LUMRYZ's clinical superiority over twice-nightly oxybates and is progressing its Phase 3 REVITALYZ study.
mondaq.com
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While The Orphan Battles Wage, Jazz Takes A Loss

The District Court upheld FDA's decision that Avadel's Lumryz is clinically superior to Jazz's Xywav, granting Lumryz its own orphan drug exclusivity. Jazz argued FDA's decision violated the Administrative Procedure Act, but the Court found FDA's determination was within its statutory authority and not arbitrary or capricious.
sleepreviewmag.com
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Court Denies Jazz's Challenge of Avadel's Orphan Drug Lumryz

US court upholds FDA approval of Avadel Pharmaceuticals' Lumryz, a once-nightly oxybate for narcolepsy, rejecting Jazz Pharmaceuticals' challenge on orphan status and clinical superiority grounds. Lumryz retains orphan drug exclusivity and is deemed clinically superior to existing treatments.
docwirenews.com
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Mia Grisco, Person With Narcolepsy, on the FDA Approval of LUMRYZ for Pediatric Patients

© 2024 Mashup Media, LLC, a Formedics Property. All Rights Reserved.
docwirenews.com
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Mia Grisco, Person With Narcolepsy, on the FDA's Recent Approval of LUMRYZ in Pediatrics

© 2024 Mashup Media, LLC, a Formedics Property. All Rights Reserved.

US court upholds Avadel's narcolepsy drug approval amid exclusivity battle

US District Court upholds FDA's approval of Avadel's narcolepsy drug Lumryz, rejecting Jazz Pharmaceuticals' claim that it infringes on Xywav's market exclusivity. The court ruled Lumryz's single-dose regimen as clinically superior, allowing Avadel to market Lumryz with its own seven-year exclusivity.
investing.com
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Court upholds FDA approval of Avadel's narcolepsy drug LUMRYZ

Avadel Pharmaceuticals' LUMRYZ received a favorable court ruling affirming FDA approval, despite Jazz Pharmaceuticals' challenge under the Orphan Drug Act. LUMRYZ, the only once-at-bedtime oxybate treatment for narcolepsy, was also approved for pediatric use and demonstrated efficacy in clinical trials. Avadel anticipates operating income in Q3 2024, with analysts projecting over $600 million in sales by 2030. A study found 94% of participants preferred LUMRYZ over twice-nightly treatments.
news.bloomberglaw.com
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Jazz Pharma Loses Lawsuit Over FDA Approval of Rival Sleep Drug

A federal judge ruled the FDA didn’t break orphan drug exclusivity by approving Avadel CNS Pharmaceuticals LLC’s Lumryz, a rival to Jazz Pharmaceuticals PLC’s Xywav.
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