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Sodium Oxybate
Sodium oxybate, sold under the brand name Xyrem among others, is a medication used to treat two symptoms of narcolepsy: sudden muscle weakness and excessive daytime sleepiness. It is used sometimes in France and Italy as an anesthetic given intravenously; it is also used in Italy to treat alcohol addiction and alcohol withdrawal syndrome. Sodium oxybate is the sodium salt of γ-hydroxybutyric acid (GHB). The clinical trials for narcolepsy were conducted just as abuse of GHB as a club drug and date rape drug became a matter of public concern; in 2000 GHB was made a Schedule I controlled substance, while sodium oxybate, when used under an FDA NDA or IND application, was classified as a Schedule III controlled substance for medicinal use under the Controlled Substances Act, with illicit use subject to Schedule I penalties. Sodium oxybate was approved for use by the US Food and Drug Administration (FDA) to treat symptoms of narcolepsy in 2002, with a strict risk evaluation ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Black Box Warning
In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears on the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text. The FDA can require a pharmaceutical company to place a boxed warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. Economists and physicians have thoroughly studied the effects of FDA boxed warnings on prescription patterns. It is not necessarily true that a physician and patient will have a conversation about a drug's boxed warning after it is issued. For instance, an FDA-mandated boxed warning decreased rosiglitazone use by 70%, but that still meant 3.8 million people we ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clomethiazole
Clomethiazole (also called chlormethiazole or Heminevrin) is a sedative and hypnotic originally developed by Hoffmann-La Roche in the 1930s. The drug is used in treating and preventing symptoms of acute alcohol withdrawal. It is structurally related to thiamine (vitamin B1), but acts like a sedative, hypnotic, muscle relaxant and anticonvulsant, having the same mechanism of action as traditional barbiturates. It is also rarely used for the management of agitation, restlessness, short-term insomnia and Parkinson's disease in the elderly, when all other treatment options have failed. In the UK, it is sold under the brand Heminevrin ( AstraZeneca Pharmaceuticals). Other brand names include Nevrin in Romania, Distraneurin in Germany and Distraneurine in Spain. The drug is marketed either as a free base in an oily solution containing 192 mg in capsule form, or as clomethiazole edisylate syrup. Due to its high toxicity compared to similar drugs it is not recommended as a firs ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Alcohol Withdrawal Syndrome
Alcohol withdrawal syndrome (AWS) is a set of symptoms that can occur following a reduction in alcohol use after a period of excessive use. Symptoms typically include anxiety, shakiness, sweating, vomiting, fast heart rate, and a mild fever. More severe symptoms may include seizures,and delirium tremens (DTs). Symptoms typically begin around six hours following the last drink, are worst at 24 to 72 hours, and improve by seven days. Alcohol withdrawal may occur in those who are alcohol dependent. This may occur following a planned or unplanned decrease in alcohol intake. The underlying mechanism involves a decreased responsiveness of GABA receptors in the brain. The withdrawal process is typically followed using the Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar). The typical treatment of alcohol withdrawal is with benzodiazepines such as chlordiazepoxide or diazepam. Often the amounts given are based on a person's symptoms. Thiamine is recommended rou ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Off-label Marketing
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs. Off-label use is very common and generally legal unless it violates ethical guidelines or safety regulations. The ability to prescribe drugs for uses beyond the officially approved indications is commonly used to good effect by healthcare providers. For example, methotrexate is commonly used off-label because its immunomodulatory effects relieve various disorders. However, off-label use can entail health risks and differences in legal liability. Marketing of pharmaceuticals for off-label use is usually prohibited. Indications and labeling laws An '' indication'' is when a drug is medically appropriate for a given condition; an ''approved indication'' is when a government drug ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
UCB (company)
UCB (Union Chimique Belge) is a multinational biopharmaceutical company headquartered in Brussels, Belgium. UCB is an international company with revenue of €4.178 billion in 2016 which focuses primarily on research and development, specifically involving medications centered on epilepsy, Parkinson's disease, and Crohn's disease. The company's efforts are focused on treatments for severe diseases treated by specialists, particularly in the fields of central nervous system (CNS) disorders (including epilepsy), inflammatory disorders (including allergy), and oncology. Every three years, the company presents the UCB Award under the patronage of the Queen Elisabeth Medical Foundation to promote neuroscience research. The winner of this award is selected by an independent scientific committee. History UCB was founded on 18 January 1928 by Emmanuel Janssen, a Belgian businessman. Initially focused on industrial chemicals (it was one of the first companies to distill ammonia fr ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Jazz Pharmaceuticals
Jazz Pharmaceuticals plc (a merger of Jazz Pharmaceuticals, Inc. and Azur Pharma plc) is a biopharmaceutical company based in Ireland. It was founded in 2003. One of the company's considerable products is the United States Food and Drug Administration (FDA) approved drug Xyrem (sodium oxybate), the sodium salt of the naturally occurring neurotransmitter γ-Hydroxybutyric acid (GHB). In 2017, net product sales of Xyrem were $1.187 billion, which represented 74% of the company's total net product sales. In 2019, Jazz was granted FDA-approval to market Sunosi with indications for treating excessive daytime sleepiness (EDS) in narcolepsy as well as obstructive sleep apnea (OSA). In 2022, it was announced that Axsome Therapeutics would be acquiring Sunosi from Jazz Pharmaceuticals In 2007, the company pled guilty to felony charges related to its illegal marketing of Xyrem for off-label use. The company is also a member of the Pharmaceutical Research and Manufacturers of Ame ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Development
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug. The entire process – from concept through preclinical testing in the laboratory to clinical trial development, including Phase I–III trials – to approved vaccine or drug typically takes more than a decade. New chemical entity development Broadly, the process of drug development can be divided into preclinical and clinical work. Pre-clinical New chemical entities (NCEs, also known as new molecular entities or NMEs) are compounds that emerge from the process of drug discovery. Th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Convention On Psychotropic Substances
The Convention on Psychotropic Substances of 1971 is a United Nations treaty designed to control psychoactive drugs such as amphetamine-type stimulants, barbiturates, benzodiazepines, and psychedelics signed in Vienna, Austria on 21 February 1971. The Single Convention on Narcotic Drugs of 1961 did not ban the many newly discovered psychotropics, since its scope was limited to drugs with cannabis, coca and opium-like effects. During the 1960s such drugs became widely available, and government authorities opposed this for numerous reasons, arguing that along with negative health effects, drug use led to lowered moral standards. The Convention, which contains import and export restrictions and other rules aimed at limiting drug use to scientific and medical purposes, came into force on 16 August 1976. As of 2013, 183 member states are Parties to the treaty. Many laws have been passed to implement the Convention, including the Canadian Controlled Drugs and Substances Act, th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been described as a ''sui generis'' political entity (without precedent or comparison) combining the characteristics of both a federation and a confederation. Containing 5.8per cent of the world population in 2020, the EU generated a nominal gross domestic product (GDP) of around trillion in 2021, constituting approximately 18per cent of global nominal GDP. Additionally, all EU states but Bulgaria have a very high Human Development Index according to the United Nations Development Programme. Its cornerstone, the Customs Union, paved the way to establishing an internal single market based on standardised legal framework and legislation that applies in all member states in those matters, and only those matters, where the states have agreed to ac ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Canada
Canada is a country in North America. Its ten provinces and three territories extend from the Atlantic Ocean to the Pacific Ocean and northward into the Arctic Ocean, covering over , making it the world's second-largest country by total area. Its southern and western border with the United States, stretching , is the world's longest binational land border. Canada's capital is Ottawa, and its three largest metropolitan areas are Toronto, Montreal, and Vancouver. Indigenous peoples have continuously inhabited what is now Canada for thousands of years. Beginning in the 16th century, British and French expeditions explored and later settled along the Atlantic coast. As a consequence of various armed conflicts, France ceded nearly all of its colonies in North America in 1763. In 1867, with the union of three British North American colonies through Confederation, Canada was formed as a federal dominion of four provinces. This began an accretion of provinces an ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Substance Dependence
Substance dependence, also known as drug dependence, is a biopsychological situation whereby an individual's functionality is dependent on the necessitated re-consumption of a psychoactive substance because of an adaptive state that has developed within the individual from psychoactive substance consumption that results in the experience of withdrawal and that necessitates the re-consumption of the drug. A '' drug addiction'', a distinct concept from substance dependence, is defined as compulsive, out-of-control drug use, despite negative consequences. An ''addictive drug'' is a drug which is both rewarding and reinforcing. ΔFosB, a gene transcription factor, is now known to be a critical component and common factor in the development of virtually all forms of behavioral and drug addictions, but not dependence. The International Classification of Diseases classifies substance dependence as a mental and behavioural disorder. Within the framework of the 4th edition of the '' Di ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
