Sodium oxybate

Sodium Oxybate: Medication for Narcolepsy and More

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Chemical structure of Sodium Oxybate (GHB).

Sodium oxybate, known under the trade names Xyrem and Alcover, is a prescription medication that has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of various sleep-related conditions, particularly narcolepsy. This comprehensive article explores the uses, chemical properties, manufacturers, and regulatory approvals associated with sodium oxybate.

Introduction to Sodium Oxybate

Sodium oxybate is a medication with diverse applications in sleep medicine:

Chemical Composition

Sodium oxybate is the sodium salt of γ-hydroxybutyric acid (GHB), a naturally occurring compound found in the central nervous system.

Trade Names

Sodium oxybate is marketed under the trade names Xyrem and Alcover, depending on its approved use and location.

Approved Uses

Sodium oxybate has been sanctioned for specific medical indications:

Excessive Daytime Sleepiness (EDS)

The FDA has approved sodium oxybate for the treatment of excessive daytime sleepiness (EDS) related to narcolepsy, a chronic sleep disorder characterized by sudden and uncontrollable sleep attacks.

Cataplexy Management

Sodium oxybate has also been recognized by the FDA and Health Canada for the management of cataplexy, a symptom often associated with narcolepsy, characterized by sudden muscle weakness or paralysis.

Manufacturers and Distribution

Sodium oxybate is produced and distributed by prominent pharmaceutical companies:

Jazz Pharmaceuticals (U.S.)

In the United States, sodium oxybate is manufactured by Jazz Pharmaceuticals, a leading specialty pharmaceutical company.

Valeant Pharmaceuticals (Canada)

Valeant Pharmaceuticals, a Canadian pharmaceutical company, produces sodium oxybate for distribution in Canada.

International Use

In Italy, under the name Alcover, sodium oxybate is prescribed for the treatment of alcohol withdrawal and dependence, highlighting its diverse applications beyond sleep disorders.

GHB-3D-balls

Development

Sodium oxybate is classified as an orphan drug, intended especially to tackle an orphan disease. Its development as a prescription solution was spearheaded by the Office of Orphan Products Development (OOPD), an FDA branch focused on fostering the growth of promising solutions for rare diseases or conditions.

In 1994, the OOPD approached Orphan Medical to research sodium oxybate for narcolepsy treatment. By 1996, Orphan Medical began clinical trials after submitting an Investigational New Drug Application (IND) to the FDA. In 2000, with a "Priority Review" status from the FDA, Orphan Medical sent a New Drug Application (NDA). FDA approved sodium oxybate for treating narcoleptic patients with cataplexy in 2002. 2005 marked the acquisition of the Xyrem brand by Jazz Pharmaceuticals and further approvals from the FDA, Health Canada, the European Medicines Agency, and Swissmedic. In 2006, the European Union expanded its indications for sodium oxybate related to narcolepsy with cataplexy. By 2010, Jazz Pharmaceuticals concluded two Phase III clinical trials for fibromyalgia treatment with sodium oxybate, although the FDA denied the approval. Researchers continue to probe sodium oxybate's potential benefits for other conditions, including Parkinson's disease, chronic fatigue syndrome (ME), schizophrenia, binge eating, essential tremor, other non-Parkinson's movement disorders, and chronic cluster headache.

Mechanism of action

Although the exact mode of action of sodium oxybate remains undetermined, the drug's active metabolite, gamma-Hydroxybutyric acid, is believed to produce therapeutic impacts by targeting the GABAB receptor complex and the GHB receptor.

Cost

The niche nature of orphan drugs means they often carry hefty price tags due to the limited patient pool. Xyrem's price in the US has surged annually since its debut. However, European nations often have governmental bodies controlling or regulating medical service and product pricing, ensuring medications like sodium oxybate are more affordable. Cost disparities are evident when comparing Xyrem's prices in the US and the UK.

Protective US patents on sodium oxybate prevent rival firms from producing the drug, safeguarded by multiple patents set to expire between 2019 and 2024.

Distribution

Ensuring sodium oxybate's safe and suitable use entails several manufacturer-imposed measures. In the US, obtaining sodium oxybate requires a prescription under a restricted distribution program called the "Xyrem Success Program," mandated by the FDA to maintain product safety and deter misuse.

Safety

Endorsed by the American Academy of Sleep Medicine (AASM), sodium oxybate has been a reliable treatment for narcolepsy-related symptoms for over seven years. Analyses have revealed extremely low rates of abuse, dependence, and misuse.

However, it's essential to note that sodium oxybate is classified as a controlled substance in various regions, including the US, Canada, and the European Union.

Adverse effects

Typically, patients tolerate sodium oxybate well. However, some might experience nausea, dizziness, headaches, or other side effects. Serious repercussions can include hallucinations, agitation, and severe confusion.

• Narcolepsy
• Cataplexy
• Excessive daytime sleepiness
• Alcohol withdrawal syndrome

Chemical Structure

The chemical structure of sodium oxybate (GHB) is shown in the image above. Understanding its chemical composition is crucial for its medical applications.

Regulatory Approvals

Sodium oxybate has received regulatory approvals from respected authorities:

U.S. Food and Drug Administration (FDA)

The FDA's approval of sodium oxybate for narcolepsy-related conditions underscores its safety and efficacy.

Health Canada

Health Canada's recognition of sodium oxybate reaffirms its value as a treatment option for narcolepsy patients in Canada.

References

• 1. U.S. Food and Drug Administration (FDA). (2021). Xyrem (sodium oxybate) Approval History.
• 2. Health Canada. (2021). Xyrem (sodium oxybate) Product Monograph.

Conclusion

Sodium oxybate, marketed as Xyrem and Alcover, is a valuable medication approved for the treatment of narcolepsy-related symptoms, including excessive daytime sleepiness (EDS) and cataplexy. Its chemical composition, approved uses, and manufacturers make it an essential component of sleep medicine, providing relief to individuals affected by these sleep disorders.

For further information on related topics, please explore our Sleep Disorders and Pharmaceutical Industry articles.

External links

• Xyrem Official Website Jazz Pharmaceuticals
• Xyrem Package Insert
• WebMD – Xyrem
• Jazz Pharmaceuticals Official Website - Information about the manufacturer of Xyrem.
• Valeant Pharmaceuticals Official Website - Details about the manufacturer of sodium oxybate in Canada.

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