Xyrem
Encyclopedia
Xyrem is a prescription medication manufactured by Jazz Pharmaceuticals, and is approved by the U.S. Food and Drug Administration
(FDA) for the treatment of cataplexy
associated with narcolepsy
and Excessive Daytime Sleepiness
(EDS) associated with narcolepsy
. Sodium oxybate is the sodium salt of γ-hydroxybutyric acid
.
The American Academy of Sleep Medicine
(AASM) recommends Xyrem as a standard of care for the treatment of cataplexy, daytime sleepiness, and disrupted sleep due to narcolepsy in its Practice Parameters for the Treatment of Narcolepsy and other Hypersomnias of Central Origin. These recommendations are based upon careful review of the medical literature, and the designation "standard" of care "reflects a high degree of clinical certainty" based on strong empirical evidence.
Xyrem is a prescription medication used to treat narcolepsy
, which is a rare medical condition that has been documented worldwide, with a prevalence ranging from 0.002% in Israel to 0.18% in Japan. Prevalence in the US is approximately 0.05%. The pentad of clinical symptoms includes: Excessive Daytime Sleepiness
(EDS), cataplexy
, hypnagogic hallucinations, sleep paralysis
, and fragmented sleep. EDS and cataplexy are the most common daytime symptoms of narcolepsy.
Xyrem (Alcover) is also used therapeutically in Italy
for treatment of alcohol withdrawal
and dependence.
, which is a pharmaceutical agent
that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease. The assignment of orphan status to a disease and to any drugs developed to treat it is a matter of public policy
in many countries, and has resulted in medical breakthroughs that may not have otherwise been achieved due to the economics of drug research and development. In the last 20 years efforts have been made to encourage companies to develop orphan drugs. The Orphan Drug Act in the US (1983) was succeeded by similar legislation in Japan
(1985), Australia
(1997), and the European Community (2000).
The development of Xyrem (sodium oxybate) oral solution as a prescription medication was initiated by the Office of Orphan Products Development (OOPD). The OOPD is a department of the FDA dedicated to promoting the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.
There are also ongoing tests to see if Xyrem could prove helpful with other medical conditions, such as Parkinson's disease
, chronic fatigue syndrome
(ME), schizophrenia
, binge eating
, essential tremor
and other non-Parkinson's movement disorders, and chronic cluster headache
.
, the precise mechanism of action
for the prescription medication Xyrem is unknown.
In European Union
(EU) countries, the government either provides national health insurance (as in the UK and Italy
) or strictly regulates quasi-private social insurance funds (as in Germany
, France
, and the Netherlands
). These government agencies are the sole purchaser (or regulator) of medical goods and services and have the power to set prices. The cost of pharmaceuticals, including Xyrem, tend to be lower in these countries.
In the US, the cost of Xyrem is $1,649 per 180 mL bottle (500 mg/mL. The effective dose range is 6–9 grams per night, which equates to $3,298 (6g) to $4,947 (9g) per month. Xyrem is covered by most insurance plans including Medicare and Medicaid and approximately 90% of Xyrem patients have a flat monthly co-pay. 75% of Xyrem insurance copays are less than $50 and 42% are less than $25 for a one-month supply. The manufacturer offers a coupon program
for the small number of patients with larger co-pays. Some insurance companies may require physicians to fill out an insurance form called a Prior Authorization as part of the prescribing process. Additionally, the manufacturer offers a Patient Assistance Program to patients that do not have insurance and are unable to afford their Xyrem prescription. Approximately 8% of Xyrem patients currently participate in this program and receive their prescription for free.
Existing US Patents
on Xyrem prevent other companies from manufacturing it as a drug. Xyrem is protected by US Patents 6472431, and 6780889 In total, Xyrem is protected by eight patents related to the product's formulation and Jazz Pharmaceuticals' distribution system. These patents expire from 2019 to 2024.
The program involves many risk management components, such as:
The program includes a single centralized pharmacy with a toll-free number.
Initial dosages are set by the prescribing physician. Each bottle of Xyrem is shipped with a graduated syringe
(measured in grams) and two dosing cups. Each night, the patient mixes two doses with 60 ml of water (sometimes substituted with a calorie-free beverage to cover the unpleasant taste of the medication). The first dose is taken at bedtime
, and the second is taken 2.5 to 4 hours later.
The analysis also found 2 confirmed cases (0.008%) of sodium oxybate–facilitated sexual assault; in both cases the women knew that they were taking sodium oxybate. In addition, there were 21 deaths (0.08%) in patients receiving sodium oxybate treatment, with 1 death known to be related to sodium oxybate, and 3 cases (0.01%) of traffic accidents involving drivers taking sodium oxybate. The extremely low rates of abuse, dependence, withdrawal, and assault found in this analysis suggest that after seven years of commercial availability, Xyrem use is largely appropriate and confined to patients with legitimate therapeutic needs.
In the US, Xyrem is classified as a Schedule III controlled substance for medicinal use under the Controlled Substances Act
, with illicit use subject to Schedule I penalties. Examples of other schedule III products in the US include vicodin
, tylenol with codeine
, and testosterone
. In Canada
and the European Union
(EU), it is classified as a Schedule III and a Schedule IV controlled substance, respectively.
(GH) and changes in energy metabolism. Serious side effects, as listed on all prescriptions of Xyrem, can include hallucinations, agitation, severe mental confusion, abnormal thinking, disrupted sleep, and depression.
Note: On October 18, 2011, Jazz Pharmaceuticals, Inc. disclosed that it had received a Warning Letter from the FDA for specific violations during the FDA's inspection of the firm from April 27, 2011 through May 6, 2011. In the letter the FDA cited 2 specific violations:
1. Failure to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to FDA [21 C.F.R § 314.80(b)].
and:
2. Failure to submit adverse drug experience (ADE) reports that are both serious and unexpected to FDA within 15 calendar days of initial receipt of the information by the applicant [21 C.F.R. § 314.80(c)(1)(i)].
The firm also received an FDA form 483 on September 27, 2007.
For complete information regarding the most recent warning go to:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm275565.htm
to resume his career and is the only treatment for narcolepsy approved by the World Anti-Doping Agency
.
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) for the treatment of cataplexy
Cataplexy
Cataplexy is a sudden and transient episode of loss of muscle tone, often triggered by emotions. It is a rare disease , but affects roughly 70% of people who have narcolepsy...
associated with narcolepsy
Narcolepsy
Narcolepsy is a chronic sleep disorder, or dyssomnia, characterized by excessive sleepiness and sleep attacks at inappropriate times, such as while at work. People with narcolepsy often experience disturbed nocturnal sleep and an abnormal daytime sleep pattern, which often is confused with insomnia...
and Excessive Daytime Sleepiness
Excessive daytime sleepiness
Excessive daytime sleepiness is characterized by persistent sleepiness, and often a general lack of energy, even after apparently adequate night time sleep...
(EDS) associated with narcolepsy
Narcolepsy
Narcolepsy is a chronic sleep disorder, or dyssomnia, characterized by excessive sleepiness and sleep attacks at inappropriate times, such as while at work. People with narcolepsy often experience disturbed nocturnal sleep and an abnormal daytime sleep pattern, which often is confused with insomnia...
. Sodium oxybate is the sodium salt of γ-hydroxybutyric acid
Gamma-Hydroxybutyric acid
γ-Hydroxybutyric acid , also known as 4-hydroxybutanoic acid and sodium oxybate when used for medicinal purposes, is a naturally occurring substance found in the central nervous system, wine, beef, small citrus fruits, and almost all animals in small amounts. It is also categorized as an illegal...
.
The American Academy of Sleep Medicine
American Academy of Sleep Medicine
The American Academy of Sleep Medicine is a United States professional society for the medical subspecialty of sleep medicine. It was established in 1975. The AASM is the only professional society that is dedicated exclusively to the medical subspecialty of sleep medicine...
(AASM) recommends Xyrem as a standard of care for the treatment of cataplexy, daytime sleepiness, and disrupted sleep due to narcolepsy in its Practice Parameters for the Treatment of Narcolepsy and other Hypersomnias of Central Origin. These recommendations are based upon careful review of the medical literature, and the designation "standard" of care "reflects a high degree of clinical certainty" based on strong empirical evidence.
Xyrem is a prescription medication used to treat narcolepsy
Narcolepsy
Narcolepsy is a chronic sleep disorder, or dyssomnia, characterized by excessive sleepiness and sleep attacks at inappropriate times, such as while at work. People with narcolepsy often experience disturbed nocturnal sleep and an abnormal daytime sleep pattern, which often is confused with insomnia...
, which is a rare medical condition that has been documented worldwide, with a prevalence ranging from 0.002% in Israel to 0.18% in Japan. Prevalence in the US is approximately 0.05%. The pentad of clinical symptoms includes: Excessive Daytime Sleepiness
Excessive daytime sleepiness
Excessive daytime sleepiness is characterized by persistent sleepiness, and often a general lack of energy, even after apparently adequate night time sleep...
(EDS), cataplexy
Cataplexy
Cataplexy is a sudden and transient episode of loss of muscle tone, often triggered by emotions. It is a rare disease , but affects roughly 70% of people who have narcolepsy...
, hypnagogic hallucinations, sleep paralysis
Sleep paralysis
Sleep paralysis is paralysis associated with sleep that may occur in healthy persons or may be associated with narcolepsy, cataplexy, and hypnagogic hallucinations. The pathophysiology of this condition is closely related to the normal hypotonia that occurs during REM sleep. When considered to be a...
, and fragmented sleep. EDS and cataplexy are the most common daytime symptoms of narcolepsy.
Xyrem (Alcover) is also used therapeutically in Italy
Italy
Italy , officially the Italian Republic languages]] under the European Charter for Regional or Minority Languages. In each of these, Italy's official name is as follows:;;;;;;;;), is a unitary parliamentary republic in South-Central Europe. To the north it borders France, Switzerland, Austria and...
for treatment of alcohol withdrawal
Alcohol withdrawal syndrome
-Protracted withdrawal:A protracted alcohol withdrawal syndrome occurs in many alcoholics where withdrawal symptoms continue beyond the acute withdrawal stage but usually at a subacute level of intensity and gradually decreasing with severity over time. This syndrome is also sometimes referred to...
and dependence.
Development
Xyrem is designated as an orphan drugOrphan drug
An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease...
, which is a pharmaceutical agent
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...
that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease. The assignment of orphan status to a disease and to any drugs developed to treat it is a matter of public policy
Public policy (law)
In private international law, the public policy doctrine or ordre public concerns the body of principles that underpin the operation of legal systems in each state. This addresses the social, moral and economic values that tie a society together: values that vary in different cultures and change...
in many countries, and has resulted in medical breakthroughs that may not have otherwise been achieved due to the economics of drug research and development. In the last 20 years efforts have been made to encourage companies to develop orphan drugs. The Orphan Drug Act in the US (1983) was succeeded by similar legislation in Japan
Japan
Japan is an island nation in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south...
(1985), Australia
Australia
Australia , officially the Commonwealth of Australia, is a country in the Southern Hemisphere comprising the mainland of the Australian continent, the island of Tasmania, and numerous smaller islands in the Indian and Pacific Oceans. It is the world's sixth-largest country by total area...
(1997), and the European Community (2000).
The development of Xyrem (sodium oxybate) oral solution as a prescription medication was initiated by the Office of Orphan Products Development (OOPD). The OOPD is a department of the FDA dedicated to promoting the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.
- In 1994, the OOPD petitioned a pharmaceutical company called Orphan Medical to investigate sodium oxybate as a potential treatment for narcolepsyNarcolepsyNarcolepsy is a chronic sleep disorder, or dyssomnia, characterized by excessive sleepiness and sleep attacks at inappropriate times, such as while at work. People with narcolepsy often experience disturbed nocturnal sleep and an abnormal daytime sleep pattern, which often is confused with insomnia...
. - In 1996, Orphan Medical submitted an Investigational New DrugInvestigational New DrugThe United States Food and Drug Administration's Investigational New Drug program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines before a marketing application for the drug has been approved...
Application (IND) to the FDA and began Phase I, II, and III clinical trials to investigate the safety and efficacy of sodium oxybate. - In 2000, Orphan Medical submitted a New Drug ApplicationNew drug applicationThe New Drug Application is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration approve a new pharmaceutical for sale and marketing...
(NDA) to the FDA for Xyrem. Xyrem was granted "Priority Review", which is an expedited review process given to products that offer a major advance in treatment or treatment where no adequate therapy exists. - In 2002, Xyrem received approval from the FDA for the treatment of cataplexyCataplexyCataplexy is a sudden and transient episode of loss of muscle tone, often triggered by emotions. It is a rare disease , but affects roughly 70% of people who have narcolepsy...
in patients with narcolepsy. - In 2005, Xyrem was acquired by Jazz Pharmaceuticals when they purchased Orphan Medical. Later that year, Xyrem was granted a second indication by the FDA for the treatment of EDSExcessive daytime sleepinessExcessive daytime sleepiness is characterized by persistent sleepiness, and often a general lack of energy, even after apparently adequate night time sleep...
in patients with narcolepsy. Also that year Xyrem was approved for the treatment of cataplexy in patients with narcolepsy by Health CanadaHealth CanadaHealth Canada is the department of the government of Canada with responsibility for national public health.The current Minister of Health is Leona Aglukkaq, a Conservative Member of Parliament appointed to the position by Prime Minister Stephen Harper.-Branches, regions and agencies:Health Canada...
's Therapeutic Products DirectorateTherapeutic Products DirectorateTherapeutic Products Directorate is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States...
, and for the same indication in adult patients by the European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
for the European UnionEuropean UnionThe European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
(EU) and the Swiss Agency for Therapeutic Products, SwissmedicSwissmedicSwissmedic, the Swiss Agency for Therapeutic Products, is the Swiss surveillance authority for medicines and medical devices, registered in Berne. It started operations on 1 January 2002 as successor of Interkantonale Kontrollstelle für Heilmittel , which was itself the successor of Schweizerische...
. - In 2006, Xyrem received an expanded indication for narcolepsy with cataplexy in the EU.
- In 2010, Jazz Pharmaceuticals completed two Phase III clinical trials investigating sodium oxybate for the treatment of fibromyalgiaFibromyalgiaFibromyalgia is a medical disorder characterized by chronic widespread pain and allodynia, a heightened and painful response to pressure. It is an example of a diagnosis of exclusion...
. Fibromyalgia is a complex musculoskeletal disorder clinically characterized by widespread pain usually accompanied by fatigue, insomniaInsomniaInsomnia is most often defined by an individual's report of sleeping difficulties. While the term is sometimes used in sleep literature to describe a disorder demonstrated by polysomnographic evidence of disturbed sleep, insomnia is often defined as a positive response to either of two questions:...
, and dyscognitionCognitive dysfunctionCognitive dysfunction is defined as unusually poor mental function, associated with confusion, forgetfulness and difficulty concentrating...
. The company submitted a New Drug ApplicationNew drug applicationThe New Drug Application is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration approve a new pharmaceutical for sale and marketing...
(NDA) to the FDA; approval was refused in October.
There are also ongoing tests to see if Xyrem could prove helpful with other medical conditions, such as Parkinson's disease
Parkinson's disease
Parkinson's disease is a degenerative disorder of the central nervous system...
, chronic fatigue syndrome
Chronic fatigue syndrome
Chronic fatigue syndrome is the most common name used to designate a significantly debilitating medical disorder or group of disorders generally defined by persistent fatigue accompanied by other specific symptoms for a minimum of six months, not due to ongoing exertion, not substantially...
(ME), schizophrenia
Schizophrenia
Schizophrenia is a mental disorder characterized by a disintegration of thought processes and of emotional responsiveness. It most commonly manifests itself as auditory hallucinations, paranoid or bizarre delusions, or disorganized speech and thinking, and it is accompanied by significant social...
, binge eating
Binge eating
Binge eating is a pattern of disordered eating which consists of episodes of uncontrollable eating. It is sometimes as a symptom of binge eating disorder. During such binges, a person rapidly consumes an excessive amount of food...
, essential tremor
Essential tremor
Essential tremor is a slowly progressive neurological disorder whose most recognizable feature is a tremor of the arms that is apparent during voluntary movements such as eating and writing...
and other non-Parkinson's movement disorders, and chronic cluster headache
Cluster headache
Cluster headache, nicknamed "suicide headache", is a neurological disease that involves, as its most prominent feature, an immense degree of pain in the head. Cluster headaches occur periodically: spontaneous remissions interrupt active periods of pain. The cause of the disease is currently unknown...
.
Mechanism of action
According to the U.S. Food and Drug AdministrationFood and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
, the precise mechanism of action
Mechanism of action
In pharmacology, the term mechanism of action refers to the specific biochemical interaction through which a drug substance produces its pharmacological effect...
for the prescription medication Xyrem is unknown.
Cost
Orphan drugs by their nature are very specialized and have relatively few patients to spread the costs associated with bringing them to market. The average cost of a specialty drug in the US is $2,875 per month or $34,500 annually, however drug prices vary by country.In European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
(EU) countries, the government either provides national health insurance (as in the UK and Italy
Italy
Italy , officially the Italian Republic languages]] under the European Charter for Regional or Minority Languages. In each of these, Italy's official name is as follows:;;;;;;;;), is a unitary parliamentary republic in South-Central Europe. To the north it borders France, Switzerland, Austria and...
) or strictly regulates quasi-private social insurance funds (as in Germany
Germany
Germany , officially the Federal Republic of Germany , is a federal parliamentary republic in Europe. The country consists of 16 states while the capital and largest city is Berlin. Germany covers an area of 357,021 km2 and has a largely temperate seasonal climate...
, France
France
The French Republic , The French Republic , The French Republic , (commonly known as France , is a unitary semi-presidential republic in Western Europe with several overseas territories and islands located on other continents and in the Indian, Pacific, and Atlantic oceans. Metropolitan France...
, and the Netherlands
Netherlands
The Netherlands is a constituent country of the Kingdom of the Netherlands, located mainly in North-West Europe and with several islands in the Caribbean. Mainland Netherlands borders the North Sea to the north and west, Belgium to the south, and Germany to the east, and shares maritime borders...
). These government agencies are the sole purchaser (or regulator) of medical goods and services and have the power to set prices. The cost of pharmaceuticals, including Xyrem, tend to be lower in these countries.
In the US, the cost of Xyrem is $1,649 per 180 mL bottle (500 mg/mL. The effective dose range is 6–9 grams per night, which equates to $3,298 (6g) to $4,947 (9g) per month. Xyrem is covered by most insurance plans including Medicare and Medicaid and approximately 90% of Xyrem patients have a flat monthly co-pay. 75% of Xyrem insurance copays are less than $50 and 42% are less than $25 for a one-month supply. The manufacturer offers a coupon program
Drug Coupon
A drug coupon is a coupon intended to help consumers save money on pharmaceutical drugs. They are offered by drug companies or distributed to consumers via doctors and pharmacists, and most can be obtained online...
for the small number of patients with larger co-pays. Some insurance companies may require physicians to fill out an insurance form called a Prior Authorization as part of the prescribing process. Additionally, the manufacturer offers a Patient Assistance Program to patients that do not have insurance and are unable to afford their Xyrem prescription. Approximately 8% of Xyrem patients currently participate in this program and receive their prescription for free.
Existing US Patents
Patent
A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention....
on Xyrem prevent other companies from manufacturing it as a drug. Xyrem is protected by US Patents 6472431, and 6780889 In total, Xyrem is protected by eight patents related to the product's formulation and Jazz Pharmaceuticals' distribution system. These patents expire from 2019 to 2024.
Distribution
A number of measures have been put in place by Xyrem's manufacture to ensure that it is used safely and appropriately. Xyrem requires a prescription and can only be obtained through a restricted distribution program, called the "Xyrem Success Program". This restricted distribution program is required by the FDA as part of a Risk Management Program (RMP) to manage product safety and prevent abuse.The program involves many risk management components, such as:
- Physician education
- Registration
- Patient education
- Detailed patient surveillance
The program includes a single centralized pharmacy with a toll-free number.
Initial dosages are set by the prescribing physician. Each bottle of Xyrem is shipped with a graduated syringe
Syringe
A syringe is a simple pump consisting of a plunger that fits tightly in a tube. The plunger can be pulled and pushed along inside a cylindrical tube , allowing the syringe to take in and expel a liquid or gas through an orifice at the open end of the tube...
(measured in grams) and two dosing cups. Each night, the patient mixes two doses with 60 ml of water (sometimes substituted with a calorie-free beverage to cover the unpleasant taste of the medication). The first dose is taken at bedtime
Bedtime
Bedtime, in Western parenting tradition, involves to a greater or lesser extent, rituals made to help children feel more secure, and become accustomed toward a comparatively more rigid sleep schedule than they would otherwise establish....
, and the second is taken 2.5 to 4 hours later.
Safety
Xyrem has been safely used by patients with narcolepsy for more than seven years. A recent analysis evaluated the postmarketing safety of Xyrem (Wang et al. 2009), including rates of abuse, dependence, and withdrawal, using a conservative application of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria to all worldwide Xyrem adverse event cases containing reporting terminology related to abuse or misuse. The analysis included cases reported to the manufacture from market introduction in 2002 through March 2008. Using the DSM-IV criteria, the analysis found the following rates of abuse, dependence, and withdrawal of the approximately 26,000 patients who used Xyrem during this period:- Abuse – 10 cases (0.04%)
- Dependence – 4 cases (0.016%)
- Withdrawal symptoms after discontinuation – 8 cases (0.031%; including 3 of the previous 4 dependence cases)
The analysis also found 2 confirmed cases (0.008%) of sodium oxybate–facilitated sexual assault; in both cases the women knew that they were taking sodium oxybate. In addition, there were 21 deaths (0.08%) in patients receiving sodium oxybate treatment, with 1 death known to be related to sodium oxybate, and 3 cases (0.01%) of traffic accidents involving drivers taking sodium oxybate. The extremely low rates of abuse, dependence, withdrawal, and assault found in this analysis suggest that after seven years of commercial availability, Xyrem use is largely appropriate and confined to patients with legitimate therapeutic needs.
In the US, Xyrem is classified as a Schedule III controlled substance for medicinal use under the Controlled Substances Act
Controlled Substances Act
The Controlled Substances Act was enacted into law by the Congress of the United States as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. The CSA is the federal U.S. drug policy under which the manufacture, importation, possession, use and distribution of certain...
, with illicit use subject to Schedule I penalties. Examples of other schedule III products in the US include vicodin
Vicodin
Hydrocodone/paracetamol is a combination of two analgesic products hydrocodone and paracetamol used to relieve moderate to severe pain...
, tylenol with codeine
Co-codamol
Co-codamol is a non-proprietary name used to denote a compound analgesic, a combination of codeine phosphate and paracetamol . Co-codamol Co-codamol (BAN) is a non-proprietary name used to denote a compound analgesic, a combination of codeine phosphate and paracetamol (acetaminophen). Co-codamol...
, and testosterone
Testosterone
Testosterone is a steroid hormone from the androgen group and is found in mammals, reptiles, birds, and other vertebrates. In mammals, testosterone is primarily secreted in the testes of males and the ovaries of females, although small amounts are also secreted by the adrenal glands...
. In Canada
Canada
Canada is a North American country consisting of ten provinces and three territories. Located in the northern part of the continent, it extends from the Atlantic Ocean in the east to the Pacific Ocean in the west, and northward into the Arctic Ocean...
and the European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
(EU), it is classified as a Schedule III and a Schedule IV controlled substance, respectively.
Adverse effects
Xyrem is generally well-tolerated by most patients. The most common side effects reported in clinical trials include nausea, dizziness, headache, vomiting, sleepiness, and bed-wetting. Some patients treated with Xyrem have also experienced moderate to significant weight loss. This may be due to the fact that Xyrem improves sleep architecture and increases the length of deep sleep stages, resulting in increased production of human growth hormoneGrowth hormone
Growth hormone is a peptide hormone that stimulates growth, cell reproduction and regeneration in humans and other animals. Growth hormone is a 191-amino acid, single-chain polypeptide that is synthesized, stored, and secreted by the somatotroph cells within the lateral wings of the anterior...
(GH) and changes in energy metabolism. Serious side effects, as listed on all prescriptions of Xyrem, can include hallucinations, agitation, severe mental confusion, abnormal thinking, disrupted sleep, and depression.
Note: On October 18, 2011, Jazz Pharmaceuticals, Inc. disclosed that it had received a Warning Letter from the FDA for specific violations during the FDA's inspection of the firm from April 27, 2011 through May 6, 2011. In the letter the FDA cited 2 specific violations:
1. Failure to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to FDA [21 C.F.R § 314.80(b)].
and:
2. Failure to submit adverse drug experience (ADE) reports that are both serious and unexpected to FDA within 15 calendar days of initial receipt of the information by the applicant [21 C.F.R. § 314.80(c)(1)(i)].
The firm also received an FDA form 483 on September 27, 2007.
For complete information regarding the most recent warning go to:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm275565.htm
Use by athletes
Xyrem has been instrumental in allowing cyclist Franck BouyerFranck Bouyer
Franck Bouyer is a French professional road bicycle racer for who races for Bbox Bouygues Telecom. Bouyer suffers from narcolepsy, resulting in sudden sleep attacks and cataplexy, and was unable to compete or train without Modafinil...
to resume his career and is the only treatment for narcolepsy approved by the World Anti-Doping Agency
World Anti-Doping Agency
The World Anti-Doping Agency , , is an independent foundation created through a collective initiative led by the International Olympic Committee . It was set up on November 10, 1999 in Lausanne, Switzerland, as a result of what was called the "Declaration of Lausanne", to promote, coordinate and...
.
See also
- NarcolepsyNarcolepsyNarcolepsy is a chronic sleep disorder, or dyssomnia, characterized by excessive sleepiness and sleep attacks at inappropriate times, such as while at work. People with narcolepsy often experience disturbed nocturnal sleep and an abnormal daytime sleep pattern, which often is confused with insomnia...
- CataplexyCataplexyCataplexy is a sudden and transient episode of loss of muscle tone, often triggered by emotions. It is a rare disease , but affects roughly 70% of people who have narcolepsy...
- Excessive daytime sleepinessExcessive daytime sleepinessExcessive daytime sleepiness is characterized by persistent sleepiness, and often a general lack of energy, even after apparently adequate night time sleep...
- Alcohol withdrawal syndromeAlcohol withdrawal syndrome-Protracted withdrawal:A protracted alcohol withdrawal syndrome occurs in many alcoholics where withdrawal symptoms continue beyond the acute withdrawal stage but usually at a subacute level of intensity and gradually decreasing with severity over time. This syndrome is also sometimes referred to...
External links
- Xyrem Official Website Jazz Pharmaceuticals
- Xyrem Package Insert
- WebMD – Xyrem