MedPath

gamma-Hydroxybutyric acid

Generic Name
gamma-Hydroxybutyric acid
Brand Names
Xywav
Drug Type
Small Molecule
Chemical Formula
C4H8O3
CAS Number
591-81-1
Unique Ingredient Identifier
30IW36W5B2
Background

Gamma hydroxybutyric acid, commonly abbreviated GHB, is a therapeutic drug which is illegal in multiple countries. It is currently regulated in the US and sold by Jazz Pharmaceuticals under the name Xyrem. However, it is important to note that GHB is a designated Orphan drug (in 1985). Today Xyrem is a Schedule III drug; however GHB remains a Schedule I drug and the illicit use of Xyrem falls under penalties of Schedule I. GHB is a naturally occurring substance found in the central nervous system, wine, beef, small citrus fruits and almost all other living creatures in small amounts. It is used illegally under the street names Juice, Liquid Ecstasy or simply G, either as an intoxicant, or as a date rape drug. Xyrem is a central nervous system depressant that reduces excessive daytime sleepiness and cataplexy in patients with narcolepsy.

Indication

Used as a general anesthetic, to treat conditions such as insomnia, clinical depression, narcolepsy, and alcoholism, and to improve athletic performance.

Associated Conditions
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Associated Therapies
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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.
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.
globenewswire.com
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Avadel Pharmaceuticals Announces Favorable Ruling in Administrative Procedure Act Litigation

The U.S. District Court for the District of Columbia ruled in favor of the FDA in a suit by Jazz Pharmaceuticals regarding the approval of Avadel Pharmaceuticals' LUMRYZ, the first once-at-bedtime oxybate treatment for narcolepsy. The court upheld LUMRYZ's approval based on its clinical superiority to Jazz's twice-nightly oxybate products, allowing LUMRYZ to retain its Orphan Drug Exclusivity.
prnewswire.com
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Overdrive Defense Launches Drink Spike Defense Test Kit to Help People Party Safely

Overdrive Defense launches 3-in-1 Drink Spike Defense Test Kit, detecting GHB, Rohypnol, and Ketamine, available at 5,000 CVS Pharmacy stores and online.

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.
stocktitan.net
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Latest Stock News & Market Updates

Jazz Pharmaceuticals (JAZZ) is a global biopharmaceutical company focusing on sleep, hematology/oncology, and pain, with notable products like Xyrem, Xywav, Zepzelca, Rylaze, and Epidiolex. In 2023, it achieved $3.8 billion in revenue, completed a Phase 3 trial for Zepzelca, and advanced zanidatamab development. With $1.6 billion in cash and $5.8 billion in debt, Jazz continues to innovate through R&D and strategic acquisitions, partnering with BeiGene and Life Science Cares.
newsfilecorp.com
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Stocks to Watch in the Battle Against Fentanyl and Dangerous Drugs

Greenlane Holdings, Inc. (NASDAQ: GNLN) plans to launch fentanyl, xylazine, and drink spike detection test strips under the Safety Strips brand, available from September 25th. The global opioid overdose treatment market is expected to reach $1.54 billion in 2024, with a projected CAGR of 7.2% through 2034.
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