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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morningstar.com
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Avadel Pharmaceuticals Announces Favorable Ruling in Administrative Procedure Act Litigation

Avadel Pharmaceuticals announced the U.S. District Court upheld the FDA's approval of LUMRYZ, a once-at-bedtime oxybate treatment for narcolepsy, against Jazz Pharmaceuticals' lawsuit. LUMRYZ retains its Orphan Drug Exclusivity.
docwirenews.com
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Dr. Anne Marie Morse on the Significance of the FDA's Approval of LUMRYZ for Pediatric Patients

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

Avadel wins FDA approval for narcolepsy drug Lumryz in children

FDA approves Avadel's Lumryz for narcolepsy in children aged 7 and older, offering a once-nightly treatment option. Lumryz, already approved for adults, is superior to Jazz Pharmaceutical's Xyrem and Xywav due to its dosing regimen, which does not require middle-of-the-night administration.
pharmexec.com
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FDA Approves Expanded Indication for Lumryz in Pediatric Patients with Narcolepsy

FDA approves Avadel Pharmaceuticals’ Lumryz for pediatric narcolepsy, offering a once-nightly treatment. Lumryz, initially approved for adults, demonstrated significant improvements in a Phase III trial, with common adverse events occurring at low frequencies. This expansion addresses the challenges of middle-of-the-night dosing for pediatric patients.
healio.com
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FDA OKs supplemental NDA for Lumryz in patients aged 7 years and older with narcolepsy

FDA approves Lumryz, a once-daily extended-release therapeutic, for cataplexy or excessive daytime sleepiness in narcolepsy patients aged 7 years and older, based on the REST-ON study results.
neurologylive.com
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FDA Approves Avadel's Sodium Oxybate for Cataplexy or Excessive Daytime Sleepiness in Narcolepsy Patients

FDA approves Avadel Pharmaceuticals' sodium oxybate (Lumryz) for cataplexy or EDS in narcolepsy patients aged 7 and older, offering a once-nightly treatment option that reduces the need for middle-of-the-night dosing.

Avadel Pharma's SNDA For Lumryz Gets FDA Approval

Avadel Pharmaceuticals announces FDA approval of LUMRYZ for narcolepsy treatment in patients 7 years and older, offering a once-nightly option without middle-of-the-night dosing.
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