Instruct: Given a question, retrieve documents that answer the question.
Query: What was the first drug approved by the FDA to treat clinical depression?
Prozac was one of the first therapies in its class to treat clinical depression by blocking the uptake of serotonin within the human brain. It is prescribed to more than fifty-four million people worldwide. Prozac was approved by the U.S. FDA in 1987 for use in treating depression. In 2001 Lilly lost its U.S. patent protection for Prozac and in January 2002 the U.S. Supreme Court rejected Lilly's final appeal, a decision that allows other companies to make generic versions of the drug. Prozac has given rise to a number of comparably functioning therapies for the treatment of clinical depression and other central nervous system disorders such as obsessive compulsive disorder, bulimia nervosa, and panic disorders.
Gene therapy is the use of DNA as a pharmaceutical agent to treat disease. Gene therapy was first conceptualized in 1972, with the authors urging caution before commencing gene therapy studies in humans. The first FDA-approved gene therapy experiment in the United States occurred in 1990, on a four-year-old girl named, Ashanti DeSilva, she was treated for ADA-SCID. This is a disease that had left her defenseless against infections spreading throughout her body. Dr. W French Anderson was a major lead on this clinical trial, he worked for the National Heart, Lung, and Blood Institute Since then, over 1,700 clinical trials have been conducted using a number of techniques for gene therapy.
Antidepressants which have been shown to be effective in treating OCD include fluvoxamine (trade name Luvox), fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil), citalopram (Celexa), and clomipramine (Anafranil). Although SSRIs are known to be effective for OCD in general, there have been fewer studies on their effectiveness for intrusive thoughts. A retrospective chart review of patients with sexual symptoms treated with SSRIs showed the greatest improvement was in those with intrusive sexual obsessions typical of OCD. A study of ten patients with religious or blasphemous obsessions found that most patients responded to treatment with fluoxetine or clomipramine. Women with postpartum depression often have anxiety as well, and may need lower starting doses of SSRIs; they may not respond fully to the medication, and may benefit from adding cognitive behavioral or response prevention therapy.
In a series of relatively small studies of the combination of low-dose CPA and ethinylestradiol as a birth control pill, depression was reported to have occurred in 1.3 to 4% of cycles. This is similar to the rate of mood changes (<3.5%) observed with birth control pills containing other progestins. A pharmacoepidemiological study using data from the United Kingdom General Practice Research Database found that the incidence of depression with birth control pills containing CPA was identical to that of birth control pills containing other progestins ( = 0.99). In clinical studies of the combination of low-dose CPA and estradiol valerate for the treatment of menopausal symptoms, preexisting adverse mood symptoms have been found to be significantly improved.
However, Sterling Products did not market "Panadol" in the United States or other countries where "Bayer Aspirin" still dominated the aspirin market. Other firms began selling acetaminophen drugs, most significantly, McNeil Laboratories with liquid "Tylenol" in 1955, and "Tylenol" pills in 1958. By 1967, "Tylenol" was available without a prescription. Because it did not cause gastric irritation, acetaminophen rapidly displaced much of aspirin's sales. Another analgesic, anti-inflammatory drug was introduced in 1962: ibuprofen (sold as "Brufen" in the U.K. and "Motrin" in the U.S.). By the 1970s, aspirin had a relatively small portion of the pain reliever market, and in the 1980s sales decreased even more when ibuprofen became available without prescription.
While insomnia is a common symptom of depression, antidepressants are effective for treating sleep problems whether or not they are associated with depression. While all antidepressants help regulate sleep, some antidepressants such as amitriptyline, doxepin, mirtazapine, and trazodone can have an immediate sedative effect, and are prescribed to treat insomnia. Amitriptyline and doxepin both have antihistaminergic, anticholinergic, and antiadrenergic properties, which contribute to both their therapeutic effects and side effect profiles, while mirtazapine's side effects are primarily antihistaminergic, and trazodone's side-effects are primarily antiadrenergic. Mirtazapine is known to decrease sleep latency (i.e., the time it takes to fall asleep), promoting sleep efficiency and increasing the total amount of sleeping time in people with both depression and insomnia.
In 1959, Senator Estes Kefauver began holding congressional hearings into concerns about pharmaceutical industry practices, such as the perceived high cost and uncertain efficacy of many drugs promoted by manufacturers. There was significant opposition, however, to calls for a new law expanding the FDA's authority. This climate was rapidly changed by the thalidomide tragedy, in which thousands of European babies were born deformed after their mothers took that drug - marketed for treatment of nausea - during their pregnancies. Thalidomide had not been approved for use in the U.S. due to the concerns of an FDA reviewer, Frances Oldham Kelsey, about thyroid toxicity. However, thousands of "trial samples" had been sent to American doctors during the "clinical investigation" phase of the drug's development, which at the time was entirely unregulated by the FDA. Individual members of Congress cited the thalidomide incident in lending their support to expansion of FDA authority.
Zopiclone was developed and first introduced in 1986 by Rhône-Poulenc S.A., now part of Sanofi-Aventis, the main worldwide manufacturer. Initially, it was promoted as an improvement on benzodiazepines, but a recent meta-analysis found it was no better than benzodiazepines in any of the aspects assessed. On April 4, 2005, the U.S. Drug Enforcement Administration listed zopiclone under schedule IV, due to evidence that the drug has addictive properties similar to benzodiazepines.
Dopamine was first synthesized in 1910 by George Barger and James Ewens at Wellcome Laboratories in London, England and first identified in the human brain by Kathleen Montagu in 1957. It was named dopamine because it is a monoamine whose precursor in the Barger-Ewens synthesis is 3,4-dihydroxyphenylalanine (levodopa or L-DOPA). Dopamine's function as a neurotransmitter was first recognized in 1958 by Arvid Carlsson and Nils-Åke Hillarp at the Laboratory for Chemical Pharmacology of the National Heart Institute of Sweden. Carlsson was awarded the 2000 Nobel Prize in Physiology or Medicine for showing that dopamine is not only a precursor of norepinephrine (noradrenaline) and epinephrine (adrenaline), but is also itself a neurotransmitter.
GSK was fined for promoting Paxil/Seroxat (paroxetine) for treating depression in the under-18s, although the drug had not been approved for pediatric use.
Paxil had $4.97 billion worldwide sales in 2003. The company conducted nine clinical trials between 1994 and 2002, none of which showed that Paxil helped children with depression. From 1998 to 2003 it promoted the drug for the under-18s, paying physicians to go on all-expenses paid trips, five-star hotels and spas. From 2004 Paxil's label, along with those of similar drugs, included an FDA-mandated boxed warning that it might increase the risk of suicidal ideation and behaviour in patients under 18.
In 2016 the American College of Physicians advised that insomnia be treated first by treating comorbid conditions, then with cognitive behavioral therapy and behavioral changes, and then with drugs; doxepin was among those recommended for short-term help maintaining sleep, on the basis of weak evidence. The 2017 American Academy of Sleep Medicine recommendations focused on treatment with drugs were similar. A 2015 AHRQ review of treatments for insomnia had similar findings.
The field is generally considered to have begun in 1896 with the opening of the first psychological clinic at the University of Pennsylvania by Lightner Witmer. In the first half of the 20th century, clinical psychology was focused on psychological assessment, with little attention given to treatment. This changed after the 1940s when World War II resulted in the need for a large increase in the number of trained clinicians. Since that time, three main educational models have developed in the USA—the Ph.D. Clinical Science model (heavily focused on research), the Ph.D. science-practitioner model (integrating research and practice), and the Psy.D. practitioner-scholar model (focusing on clinical practice). In the UK and the Republic of Ireland the Clinical Psychology Doctorate falls between the latter two of these models, whilst in much of mainland Europe the training is at masters level and predominantly psychotherapeutic. Clinical psychologists are expert in providing psychotherapy, and generally train within four primary theoretical orientations—psychodynamic, humanistic, cognitive behavioral therapy (CBT), and systems or family therapy.
At very low doses, doxepin has not shown discontinuation or withdrawal effects nor rebound insomnia. Sustained effectiveness without apparent tolerance was demonstrated in clinical studies of up to 12 weeks duration. This appears to be in contrast to over-the-counter antihistamines like diphenhydramine and doxylamine and all other first-generation antihistamines, which are associated with rapid development of tolerance and dependence (by day 3 or 4 of continuous dosing) and loss of hypnotic effectiveness. It is for this reason that, unlike doxepin, they are not recommended for the chronic management of insomnia and are advised for only short-term treatment (i.e., 1 week). It is not entirely clear why doxepin and first-generation antihistamines are different in this regard, but it has been suggested that it may have to do with the lack of selectivity for the H receptor of the latter or may have to do with the use of optimal doses. Unlike very-low-dose doxepin, most first-generation antihistamines also have marked anticholinergic activity as well as associated side effects such as dry mouth, constipation, urinary retention, and confusion. This is particularly true in older people, and antihistamines with concomitant anticholinergic effects are not recommended in adults over the age of 65. Anticholinergic activity notably may interfere with the sleep-promoting effects of H receptor blockade.
In April 2000, Celgene reached an agreement with Novartis Pharma AG to license d-MPH, Celgene's chirally pure version of RITALIN. The FDA subsequently granted approval to market d-MPH, or Focalin, in November 2001.
Corticosteroids (cortisone), accutane (isotretinoin) and other vitamin A derivatives, barbiturates, certain antibiotics, propofol, volatile anesthetics, non-depolarizing muscle relaxants, some local anesthetics, statins, fibrates, glitazones, beta blockers, biguanides, amiodarone, some chemotherapies, some neuroleptics, nucleoside reverse transcriptase inhibitors and various other drugs.
Estradiol stearate (brand name Depofollan), or estradiol octadecanoate, is a naturally occurring steroidal estrogen and an estrogen ester – specifically, the C17β stearate ester of estradiol. It occurs in the body as a very long-lasting metabolite and prohormone of estradiol. In addition, estradiol stearate is or has been available as a pharmaceutical drug for use via depot intramuscular injection. The drug was introduced in 1941 as Depofollan and was the first long-acting estrogen, although it has never been widely used. It has been reported in at least one source to have a duration of at least one month.
A form of psychotherapy called "cognitive behavioral therapy" (CBT) and psychotropic medications are first-line treatments for OCD. Other forms of psychotherapy, such as psychodynamic and psychoanalysis may help in managing some aspects of the disorder, but in 2007 the American Psychiatric Association (APA) noted a lack of controlled studies showing their effectiveness "in dealing with the core symptoms of OCD". The fact that many individuals do not seek treatment may be due in part to stigma associated with OCD.
On July 29, 2016, Food and Drug Administration (FDA), of the United States of America approved abobotulinumtoxinA for injection for the treatment of lower limb spasticity in pediatric patients two years of age and older. AbobotulinumtoxinA is the first and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity. In the United States of America, the FDA approves the text of the labels of prescription medicines. The FDA approves which medical conditions the drug manufacturer may sell the drug for. However, those approved by the FDA to prescribe these drugs may freely prescribe them for any condition they wish, called off-label use. Botulinum toxins have been used off-label for several pediatric conditions, including infantile esotropia.
Based on data from thousands of patients collected by 240 investigators, Allergan received FDA approval in 1989 to market Oculinum for clinical use in the United States to treat adult strabismus and blepharospasm, using the trademark Botox. This was under the 1983 US Orphan Drug Act.
When compared to psychoactive medications, review studies have found CBT alone to be as effective for treating less severe forms of depression and anxiety, posttraumatic stress disorder (PTSD), tics, substance abuse, eating disorders and borderline personality disorder. It is often recommended in combination with medications for treating other conditions, such as severe obsessive compulsive disorder (OCD) and major depressive disorder, opioid use disorder, bipolar disorder and psychotic disorders. In addition, CBT is recommended as the first line of treatment for majority of psychological disorders in children and adolescents, including aggression and conduct disorder. Researchers have found that other "bona fide" therapeutic interventions were equally effective for treating certain conditions in adults. Along with interpersonal psychotherapy (IPT), CBT is recommended in treatment guidelines as a psychosocial treatment of choice, and CBT and IPT are the only psychosocial interventions that psychiatry residents are mandated to be trained in.
With the outbreak of World War II, weaponization of botulinum toxin was investigated at Fort Detrick in Maryland. Carl Lamanna and James Duff developed the concentration and crystallization techniques that Edward J. Schantz used to create the first clinical product. When the Army’s Chemical Corps was disbanded, Schantz moved to the Food Research Institute in Wisconsin, where he manufactured toxin for experimental use and generously provided it to the academic community.
Fluvoxamine was developed by Kali-Duphar, part of Solvay Pharmaceuticals, Belgium, now Abbott Laboratories, and introduced as Floxyfral in Switzerland and Solvay in West Germany in 1983. It was approved by the FDA on 5 December 1994 and introduced as Luvox in the US. In India, it is available, among several other brands, as Uvox by Abbott. It was one of the first SSRI antidepressants to be launched, and is prescribed in many countries to patients with major depression. It was the first SSRI, a non-TCA drug, approved by the U.S. FDA specifically for the treatment of OCD. At the end of 1995, more than ten million patients worldwide had been treated with fluvoxamine. Fluvoxamine was the first SSRI to be registered for the treatment of obsessive compulsive disorder in children by the FDA in 1997. In Japan, fluvoxamine was the first SSRI to be approved for the treatment of depression in 1999 and was later in 2005 the first drug to be approved for the treatment of social anxiety disorder. Fluvoxamine was the first SSRI approved for clinical use in the United Kingdom.
Clomipramine was developed by Geigy. It was first referenced in the literature in 1961 and was patented in 1963. The drug was first approved for medical use in Europe in the treatment of depression in 1970, and was the last of the major TCAs to be marketed. In fact, clomipramine was initially considered to be a "me-too drug" by the FDA, and in relation to this, was declined licensing for depression in the United States. As such, to this day, clomipramine remains the only TCA that is available in the United States that is not approved for the treatment of depression, in spite of the fact that it is a highly effective antidepressant. Clomipramine was eventually approved in the United States for the treatment of OCD in 1989 and became available in 1990. It was the first drug to be investigated and found effective in the treatment of OCD. The first reports of benefits in OCD were in 1967, and the first double-blind, placebo-controlled clinical trial of clomipramine for OCD was conducted in 1976, with more rigorous clinical studies that solidified its effectiveness conducted in the 1980s. It remained the "gold standard" for the treatment of OCD for many years until the introduction of the SSRIs, which have since largely superseded it due to greatly improved tolerability and safety (although notably not effectiveness). Clomipramine is the only TCA that has been shown to be effective in the treatment of OCD and that is approved by the FDA for the treatment of OCD; the other TCAs failed clinical trials for this indication, likely due to insufficient serotonergic activity.
Gepirone was originally developed by Bristol-Myers Squibb, but was out-licensed to Fabre-Kramer in 1993. The FDA rejected approval for gepirone in 2004. It was submitted for the preregistration (NDA) phase again in May 2007 after adding additional information from clinical trials as the FDA required in 2009. However, in 2012 it once again failed to convince the FDA of its qualities for treating anxiety and depression. In December 2015, the FDA once again gave gepirone a negative review for depression due to concerns of efficacy. However, in March 2016, the FDA reversed its decision and gave gepirone ER a positive review, clearing the way for the drug to finally gain market approval in the U.S. As of September 2017, it is still in preregistration.
In 2017, August 29 the U.S. Food and Drug Administration (FDA) approved Chemo Research’s New Drug Application (NDA) for benznidazole 567891011 . This is the first drug ever approved by the FDA to treat Chagas disease. The FDA’s decision approves benznidazole for children ages 2–12 years old 12. Mundo Sano played a central role in registering benznidazole with the U.S. Food and Drug Administration (FDA), in close collaboration with Exeltis (Chemo US-based pharmaceutical division), with the support of the Drugs for Neglected Diseases initiative (DNDi), a non-profit drug development organization.