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AstraZeneca is to report results of a major clinical trial to the Food and Drug Administration (FDA) in late September, which has been conducted by the company to evaluate the efficacy and safety of quetiapine, the second-generation antipsychotic drug used in the treatment of schizophrenia and bipolar disorder.
The trial, which was run at the New Jersey Institute of Clinical Pharmacology and Therapeutics (NICPA), is an open-label, single-dose, placebo-controlled, double-blind, randomized, controlled, phase 3 clinical study of quetiapine in schizophrenia and bipolar disorder.
The trial is designed to evaluate the effectiveness of quetiapine, and the safety of quetiapine, compared with the conventional antipsychotic olanzapine. The trial is intended to enroll patients with schizophrenia who are at least 40 years old and with a history of psychotic episodes in the last three months.
Quetiapine is available as an extended-release tablet, with a 200 mg dose.
The results of the study will be presented at the International Congress on Antipsychotic Therapy, October 3-6, in London.
The company has a patent for the drug for a number of reasons, including the potential to market it as an extended-release version, which is currently available in capsule form.
The company will release data to the FDA in early September.
FDA approval of the trial will be based on the results of an extensive Phase 3 clinical study that will enroll about 400 patients.
FDA will provide the company with data from the trial that will help to determine the efficacy and safety of quetiapine in patients with schizophrenia.
Quetiapine is the first of a new class of drugs that has been approved for the treatment of schizophrenia and bipolar disorder, but it has not yet received FDA approval for the treatment of bipolar disorder.
Schizophrenia and bipolar disorder are mental disorders that affect both the manic and depressive phases of a patient’s life. The clinical trials for quetiapine are scheduled to run from September 2006 to April 2008.
Quetiapine is a non-benzodiazepine anti-psychotic that works by helping to relax the blood vessels in the brain. It has not been approved for use in the treatment of bipolar disorder.
The new study will be conducted by ICAN (U. S. Department of Health and Human Services), which has received funding from the National Institute on Drug Abuse, the National Institute on Abrupt Price Competition and other organizations for research in the treatment of schizophrenia and bipolar disorder.
The new study is one of several in a growing number of clinical trials conducted by the company for quetiapine. This is part of an ongoing phase 3 clinical trial that has been funded by AstraZeneca.
The company expects to receive the results from the study at the end of 2008.
The company has been in discussions with the company to fund the study for later this year.
In September, the company will release data to the FDA in early September.
| |© 2013, The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
Citation: Drug company buys the rights to the Seroquel label (2013, September 3) to develop a generic version of quetiapine (2011, August 9) (submitted at the New Jersey Institute of Clinical Pharmacology and Therapeutics (NICPA))
This document is a partial and edited version of an article entitled "AstraZeneca’s Study of Quetiapine vs. Olanzapine in the Treatment of Schizophrenia and Bipolar Disorder: The Case Series of an Atypical Olanzapine Evaluator at the Institute of Clinical Pharmacology & Therapeutics in Boston". AstraZeneca Press. Published by Pfizer, Inc.
Citations:
Citation:
Thestra Pharmaceuticals, Inc. (2011, August 9) (submitted at the New Jersey Institute of Clinical Pharmacology and Therapeutics) (accessed August 9) (updated August 9). Retrieved August 19, 2011, from the AstraZeneca press release.
Seroquel XR 400mg is an antipsychotic medication used to treat certain mental health conditions. It is used to treat the symptoms of schizophrenia, bipolar disorder, and major depressive disorder. It can also be used to treat bipolar disorder, maintenance insomnia, and treatment-resistant symptoms in bipolar disorder.
One Tablet a Day (2-3 days) Treatment for Schizophrenia or Bipolar I disorder may take 1 tablet a day.
Schizophrenia is a chronic neurological condition that causes hallucinations, delusions, and confusion. Treatment with Seroquel XR will help to reduce symptoms such as hallucinations, hallucinations, and delusions by slowing down the activity of the brain's antipsychotic receptors in the cases of schizophrenia.
Paxil may be used in the treatment of schizophrenia, bipolar disorder, and major depressive disorder as long as the risks and benefits have been proven effective. However, there are some risks associated with the use of Paxil include an increased risk of suicidal thoughts and behavior. It may also have some risks, such as allergic reactions, bleeding disorders, low white blood cell counts, and possible conditions that can increase the risk of infection.
Seroquel XR 400mg may cause side effects in some individuals. The most common side effects are:
Contact your doctor immediately if these or other side effects occur. Abdominal pain or diarrhea may also occur. Patients should contact their doctor if experiencing symptoms of low white blood cell (WBC) counts.
Some side effects of Seroquel XR may be reversible upon stopping the medication. Examples of this include:
Patients should inform their doctor before taking Seroquel XR if they have:
Patients should contact their doctor immediately if they experience unusual symptoms of depression, suicidal thoughts or behaviors, or unusual changes in behavior or mood. This may include hallucinations, delusions, confusion, suicidal thoughts, agitation, restlessness, hostility, or other changes in mood.
Seroquel 25mg tablets are a trusted ally in the treatment of mental health conditions such as schizophrenia, bipolar disorder, and major depressive disorder. Each box contains 60 small, easy-to-swallow tablets, offering relief and support for over a month's supply. Key Features: - Effective Support: Designed to alleviate symptoms of schizophrenia and bipolar disorder, helping you regain stability and joy in your everyday life. - Antipsychotic Medication: Part of the renowned class of atypical antipsychotics, providing a modern approach to mental health management. - Convenient Dosing: 25mg tablets offer flexibility in dosing adjustments as prescribed by healthcare professionals. - Trusted Solution: Backed by extensive research and clinical use, ensuring safe and effective treatment options. Usage Instructions: - Dosage: Follow the instructions provided by your healthcare provider, ensuring accurate and beneficial use. - Storage: Store the tablets at room temperature, away from moisture and direct sunlight, to maintain their effectiveness. Warnings and Precautions: - Always take Seroquel under the supervision of a healthcare professional to avoid any adverse effects or interactions. - Not recommended for use in elderly patients with dementia-related psychosis due to increased risk of death. Seroquel is more than just a medication; it's a stepping stone towards better mental health and emotional balance. With the convenience of having 60 tablets at your disposal, managing your mental health condition with consistency and care has never been easier. Remember, always consult with your healthcare provider to ensure it’s the right fit for your treatment plan.
SUNLIFE #1 Online Pharmacy in Qatar, Your one place to order Seroquel 25mg Tablets - 60 Count, Antipsychotic Medication For Mental Health Support and All Medicines and Prescription Only products. Get delivered in 1 to 2 hours 24/7 FREE Shipping / Home DELIVERY.
AQUAPHContentsAQUAPHECTIC SIDE EFFECTSfood side effects Seroquel 25mg may cause some unexpected side effects when taken with other medications and/or food. If you take this medicine while allergic to quetiapine or any other medications or any of the ingredients of this medicine. If you take this medicine while allergic to quetiapine or any other medications or food. If you take this medicine while taking quetiapine or other medications. If you take this medicine while allergic to quetiapine or other medications. If you take this medicine with a medication that may cause a severe reaction if you take this medicine while allergic to quetiapine or other medications. If you take this medicine with any other medication, especially any medicines or ingredients. If you take this medicine to treat any disease. If you take this medicine to treat any disease or illness. If you take this medicine to help with food poisoning. If you take quetiapine to treat any disease. If you take quetiapine to help with food poisoning.Seroquel is an antipsychotic medication used to treat schizophrenia. It is sometimes prescribed to treat bipolar disorder. Quetiapine and quetiapine fumarate are antipsychotics approved for this indication by the FDA and are also approved by the manufacturers to treat other conditions, such as schizophrenia. Seroquel is also sometimes used to treat manic episodes associated with bipolar disorder.
Seroquel is typically taken once a day and is available in tablet form. You should be aware that you can have side effects while taking Seroquel, although these can be minor and go away once your body gets used to the medication. Seroquel is also available in tablet form and you can usually get it by purchasing the same tablet from a pharmacy or online at an online pharmacy. Your doctor will usually advise you to take Seroquel once a day in the morning, as well as at least one dose in the evening. It is important that you continue to take Seroquel until your doctor has instructed you to stop.
Seroquel side effects can range from minor to severe, but usually include the following:
Seroquel is a medication that should not be taken with other medications, including anticonvulsants, or alcohol, over the counter (OTC) products.
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