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Zuranolone
Zuranolone, sold under the brand name Zurzuvae, is a medication used for the treatment of postpartum depression. It is taken by mouth. The most common side effects include drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection. An orally active inhibitory pregnane neurosteroid, zuranolone acts as a positive allosteric modulator of the GABAA receptor. Zuranolone was approved for medical use in the United States for the treatment of postpartum depression in August 2023. It was developed by Sage Therapeutics and Biogen. Medical uses Zuranolone is indicated for the treatment of postpartum depression. Adverse effects The most common side effects include drowsiness, dizziness, diarrhea, fatigue, and urinary tract infection. The US FDA label contains a boxed warning noting that zuranolone can impact a person's ability to drive and perform other potentially hazardous activities. The use of zuranolone may cause suicidal thoughts and behavi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Postpartum Depression
Postpartum depression (PPD), also called perinatal depression, is a mood disorder which may be experienced by pregnant or postpartum women. Symptoms include extreme sadness, low energy, anxiety, crying episodes, irritability, and extreme changes in sleeping or eating patterns. PPD can also negatively affect the newborn child. The exact cause of PPD is unclear, however, it is believed to be due to a combination of physical, emotional, genetic, and social factors such as hormone imbalances and sleep deprivation. Risk factors include prior episodes of postpartum depression, bipolar disorder, a family history of depression, psychological stress, complications of childbirth, lack of support, or a drug use disorder. Diagnosis is based on a person's symptoms. While most women experience a brief period of worry or unhappiness after delivery, postpartum depression should be suspected when symptoms are severe and last over two weeks. Among those at risk, providing psychosocial su ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
GABAA Receptor Positive Allosteric Modulator
In pharmacology, GABAA receptor positive allosteric modulators, also known as GABAkines or GABAA receptor potentiators, are positive allosteric modulator (PAM) molecules that increase the activity of the GABAA receptor protein in the vertebrate central nervous system. GABA is a major inhibitory neurotransmitter in the central nervous system. Upon binding, it triggers the GABAA receptor to open its chloride channel to allow chloride ions into the neuron, making the cell hyperpolarized and less likely to fire. GABAA PAMs increase the effect of GABA by making the channel open more frequently or for longer periods. However, they have no effect if GABA or another agonist is not present. Unlike GABAA receptor agonists, GABAA PAMs do not bind at the same active site as the γ-aminobutyric acid (GABA) neurotransmitter molecule: they affect the receptor by binding at a different site on the protein. This is called allosteric modulation. In psychopharmacology, GABAA receptor PAMs u ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Oral Administration
Oral administration is a route of administration whereby a substance is taken through the Human mouth, mouth, swallowed, and then processed via the digestive system. This is a common route of administration for many medications. Oral administration can be easier and less painful than other routes of administration, such as Injection (medicine), injection. However, the onset of action is relatively low, and the effectiveness is reduced if it is not absorbed properly in the digestive system, or if it is broken down by digestive enzymes before it can reach the bloodstream. Some medications may cause gastrointestinal side effects, such as nausea or vomiting, when taken orally. Oral administration can also only be applied to conscious patients, and patients able to swallow. Terminology ''Per os'' (; ''P.O.'') is an adverbial phrase meaning literally from Latin "through the mouth" or "by mouth". The expression is used in medicine to describe a treatment that is taken orally (but not ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
The Boston Globe
''The Boston Globe,'' also known locally as ''the Globe'', is an American daily newspaper founded and based in Boston, Massachusetts. The newspaper has won a total of 27 Pulitzer Prizes. ''The Boston Globe'' is the oldest and largest daily newspaper in Boston and tenth-largest newspaper by print circulation in the nation as of 2023. Founded in 1872, the paper was mainly controlled by Irish Catholic interests before being sold to Charles H. Taylor and his family. After being privately held until 1973, it was sold to ''The New York Times'' in 1993 for $1.1billion, making it one of the most expensive print purchases in United States history. The newspaper was purchased in 2013 by Boston Red Sox and Liverpool F.C. owner John W. Henry for $70million from The New York Times Company, having lost over 90% of its value in 20 years. The chief print rival of ''The Boston Globe'' is the '' Boston Herald'', whose circulation is smaller and is shrinking faster. The newspaper is "one ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Complete Response Letter
In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its present form. CRLs replaced approvable letters in 2018. Background Under the Prescription Drug User Fee Act, the Food and Drug Administration has a limited timespan (known as the PDUFA date) to decide a New Drug Application, Abbreviated New Drug Application or Biologics License Application. The FDA may either approve the application or issue a Complete Response Letter. Grounds behind issuing a CRL may include labeling issues, current Good Manufacturing Practice concerns or concerns about the safety or effectiveness of the drug. A sponsor receiving CRL may withdraw the application, request a hearing or resubmit the application. Because heari ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Major Depressive Disorder
Major depressive disorder (MDD), also known as clinical depression, is a mental disorder characterized by at least two weeks of pervasive depression (mood), low mood, low self-esteem, and anhedonia, loss of interest or pleasure in normally enjoyable activities. Introduced by a group of US clinicians in the mid-1970s, the term was adopted by the American Psychiatric Association for this syndrome, symptom cluster under mood disorders in the 1980 version of the ''Diagnostic and Statistical Manual of Mental Disorders'' (DSM-III), and has become widely used since. The disorder causes the second-most years lived with disability, after low back pain, lower back pain. The diagnosis of major depressive disorder is based on the person's reported experiences, behavior reported by family or friends, and a mental status examination. There is no laboratory test for the disorder, but testing may be done to rule out physical conditions that can cause similar symptoms. The most common time o ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
FDA Fast Track
Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. Fast track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days. Purpose Fast track is one of five FDA approaches to make new drugs available as rapidly as possible: the others are priority review, breakthrough therapy, accelerated approval and regenerative medicine advanced therapy. Fast track was introduced by the FDA Modernization Act of 1997. Requirements Fast track designation is designed to aid in the development and expedite the review of drugs which show promise in treating a serious or life-threatening disease and address an unmet medical need. Serious condition: determ ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Priority Review
Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program is a program that grants a voucher for priority review to a drug developer as an incentive to develop treatments for disease indications with limited profitability. Priority review vouchers are currently earned by pharmaceutical companies for the development and approval of drugs treating neglected tropical diseases, rare pediatric diseases, and "medical countermeasures" for terrorism. The voucher can be used for future drugs that could have wider indications for use, but the company is required to pay a fee (approximately $2.8 million) to use the voucher. When seeking approval for a drug, manufacturers can apply to the FDA for priority review. This is granted when a drug is intended to treat a serious condition and would "provide a sig ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Diagnostic And Statistical Manual Of Mental Disorders
The ''Diagnostic and Statistical Manual of Mental Disorders'' (''DSM''; latest edition: ''DSM-5-TR'', published in March 2022) is a publication by the American Psychiatric Association (APA) for the classification of mental disorders using a common language and standard criteria. It is an internationally accepted manual on the diagnosis and treatment of mental disorders, though it may be used in conjunction with other documents. Other commonly used principal guides of psychiatry include the International Classification of Diseases (ICD), Chinese Classification of Mental Disorders (CCMD), and the ''Psychodynamic Diagnostic Manual''. However, not all providers rely on the DSM-5 as a guide, since the ICD's mental disorder diagnoses are used around the world, and scientific studies often measure changes in symptom scale scores rather than changes in DSM-5 criteria to determine the real-world effects of mental health interventions. It is used by researchers, psychiatric drug regulatio ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biological Half-life
Biological half-life (elimination half-life, pharmacological half-life) is the time taken for concentration of a drug, biological substance (such as a medication) to decrease from its maximum concentration (chemistry), concentration (Cmax (pharmacology), Cmax) to half of Cmax in the blood plasma. It is denoted by the abbreviation t_. This is used to measure the removal of things such as metabolites, drugs, and signalling molecules from the body. Typically, the biological half-life refers to the body's natural detoxification (cleansing) through liver metabolism and through the excretion of the measured substance through the kidneys and intestines. This concept is used when the rate of removal is roughly Exponential function, exponential. In a medical context, half-life explicitly describes the time it takes for the blood plasma concentration of a substance to halve (''plasma half-life'') its steady-state when circulating in the full blood of an organism. This measurement is usefu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Bioavailability
In pharmacology, bioavailability is a subcategory of absorption and is the fraction (%) of an administered drug that reaches the systemic circulation. By definition, when a medication is administered intravenously, its bioavailability is 100%. However, when a medication is administered via routes other than intravenous, its bioavailability is lower due to intestinal epithelium absorption and first-pass metabolism. Thereby, mathematically, bioavailability equals the ratio of comparing the area under the plasma drug concentration curve versus time (AUC) for the extravascular formulation to the AUC for the intravascular formulation. AUC is used because AUC is proportional to the dose that has entered the systemic circulation. Bioavailability of a drug is an average value; to take population variability into account, deviation range is shown as ±. To ensure that the drug taker who has poor absorption is dosed appropriately, the bottom value of the deviation range is employed ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
