Atypical in Medical Technology

Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia

... the first once-monthly, long-acting, injectable atypical antipsychotic approved in the U.S. for this use. ... shows that many patients treated with an oral atypical antipsychotic miss taking medication for about ... observed with INVEGA((R)) SUSTENNA(TM) and other atypical antipsychotic medications. If you notice that you ...

FDA Advisory Committee Votes in Favor of Zyprexa for Two Adolescent Indications

... (PDAC) voted that Zyprexa(R) (olanzapine), an atypical antipsychotic, is effective and acceptably safe ... death, has been reported in patients treated with atypical antipsychotics, including Zyprexa. While relative ... are inconsistent, the association between atypical antipsychotics and increases in glucose levels ...

RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder

... Treatment (RLAT) is a long-acting injectable atypical antipsychotic therapy used for the treatment of ... duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in ... Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional ...

FDA Approves Vanda Pharmaceuticals' Fanapt(TM) for the Treatment of Schizophrenia

... receptor antagonist, and belongs to the class of atypical antipsychotics. "The approval of Fanapt(TM) ... associated with some other drugs in the class of atypical antipsychotics. Similarly to some other ... adverse events. Worldwide sales from the class of atypical antipsychotics exceeded US $20 billion in 2007. ...

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and INVEGA(R)

... palmitate is an investigational once-monthly atypical antipsychotic injection which, if approved, will ... and 24% of cases respectively.(i) INVEGA, an atypical antipsychotic medication, was first approved in ... with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of ...

FDA Issues a Complete Response Letter for Lilly's Olanzapine LAI for Treatment of Schizophrenia in Adults

... death, has been reported in patients treated with atypical antipsychotics, including olanzapine. While ... are inconsistent, the association between atypical antipsychotics and increases in glucose levels ... to have a greater association than some other atypical antipsychotics. Physicians should consider the ...

First Clinical Experience With Soliris(R) in Treating Patients With Two Rare Complement-Mediated Diseases Presented at ASH Annual Meeting

... clinical experience with Soliris in patients with atypical Hemolytic Uremic Syndrome (aHUS) and Cold ... A poster titled "Successful Treatment of atypical Hemolytic Uremic Syndrome with the Complement ... Soliris is not approved for the treatment of atypical Hemolytic Uremic Syndrome (aHUS) and Cold ...

New Data on SEROQUEL XR(TM) in Treatment of Both Major Depressive Disorder and Generalized Anxiety Disorder Presented at APA Annual Meeting

... has investigated the use of SEROQUEL XR, an atypical antipsychotic, in the treatment of MDD as well as ... Patients starting treatment with atypical antipsychotics who have or are at risk for ... cases), have been reported temporally related to atypical antipsychotics, including quetiapine. Patients ...

Statement from Eli Lilly and Company: Response to Connecticut Attorney General News Release

... treated with atypical antipsychotic drugs are at an increased risk of ... to have a greater association than some other atypical antipsychotics. Physicians should consider the ... risk factors for diabetes who are starting on atypical antipsychotics should undergo baseline ...

FDA Advisory Committee Supports Efficacy and Safety of Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment

... psychosis treated -- with atypical antipsychotic drugs are at an increased ... to have a greater association than some other atypical antipsychotics. Physicians should consider the ... risk factors for diabetes who are starting on atypical antipsychotics should undergo baseline ...

AstraZeneca Submits sNDA for SEROQUEL XR(TM) for the Treatment of Generalized Anxiety Disorder - a First for the Atypical Antipsychotic Class of Medicines

... treated with atypical antipsychotics. Patients starting treatment with atypical antipsychotics who have or are at risk for diabetes should undergo fasting ... (including fatal cases), have been reported temporally related to atypical antipsychotics, including quetiapine. Patients with a pre-existing low ...

EnVivo Pharmaceuticals Announces Initiation of Clinical Safety and Biomarker Study of Alpha-7 Nicotinic Agonist, EVP-6124, in Patients with Schizophrenia

... agonist (EVP-6124) in Schizophrenia patients chronically treated with atypical antipsychotic medications. The objectives of this study are to evaluate ... approximately 20 Schizophrenia patients treated with a stable dose of an atypical antipsychotic drug. Patients are receiving one of two doses of EVP-6124 or ...

AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression

... treated with atypical antipsychotics. Patients starting treatment with atypical antipsychotics who have or are at risk for diabetes should undergo fasting ... (including fatal cases), have been reported temporally related to atypical antipsychotics, including quetiapine. Patients with a pre-existing low ...

SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia

... treated with atypical antipsychotics. Patients starting treatment with atypical antipsychotics who have or are at risk for diabetes should undergo fasting ... (including fatal cases), have been reported temporally related to atypical antipsychotics, including quetiapine. Patients with a pre-existing low ...

New Powder Speeds Healing of Difficult Foot Wounds

... the lead podiatric physician for the study and Associate Professor at Temple University School of Podiatric Medicine. The study focused on atypical wounds with irregular shapes and causes. The wounds were treated with the powder dressing once a week for four to eight weeks. The study ultimately ...

Trius Announces Positive Results From Phase 2 Clinical Trial of Torezolid in Patients With Complicated Skin and Skin Structure Infections

... all clinically important, gram-positive, drug-resistant strains including those resistant to linezolid Activity against clinically important atypical and gram-negative pathogens ( Legionella, Chlamydia, Neisseria ) 16x lower rate of resistance development in MRSA Once-daily and ...

Study Demonstrating Lurasidone Is Effective in Patients With Schizophrenia Published in The Journal of Clinical Psychiatry

... as a potential psychotropic agent for the treatment of schizophrenia. Lurasidone has a unique chemical structure that differs from conventional and atypical antipsychotic agents. It possesses high affinities for dopamine D(2), serotonin 5-HT(7), 5-HT(2A), 5-HT(1A), and noradrenaline alpha(2C) receptors. ...

AstraZeneca and Targacept Announce Top-Line Results from Phase IIb Study of AZD3480 in Cognitive Dysfunction in Schizophrenia

... States and Canada. Subjects (n = 445) between 18 and 55 years of age who were active smokers and taking medication from the class of drugs known as atypical anti-psychotics were randomly assigned to one of three dose groups of AZD3480 or to placebo and dosed over a 12-week period. The primary outcome ...

Memory Pharmaceuticals Achieves Enrollment Goal for Phase 2 Study of MEM 3454 in Cognitive Impairment Associated With Schizophrenia

... associated with the disorder." The trial is designed to include approximately 212 patients with stable schizophrenia who are receiving atypical antipsychotic therapy. Subjects in the study are randomized to receive 5 mg, 15 mg or 50 mg of R3487/MEM 3454 or placebo once daily for a period of ...

Study Suggests Treatment with Paliperidone ER Significantly Improves Symptoms of Schizoaffective Disorder

... higher dose or lower dose arm of the trial were: tremor, somnolence, dyspepsia, constipation, nasopharyngitis and hypertonia. Paliperidone ER, an atypical antipsychotic medication, was first approved in the U.S. in December 2006 and is marketed as INVEGA(R). It is approved for the acute and maintenance ...

Paratek Reports Positive Phase 2 Clinical Data on its New Antibiotic PTK 0796 in Late Breaker Presentation at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy

... and susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), as well as Gram-negative, anaerobic and atypical bacteria. Paratek is developing PTK 0796 as a firstline agent for empiric therapy for the leading infections requiring hospitalization, such as ...

Memory Pharmaceuticals and Roche Expand R3487/MEM 3454 Development Program

... potential of R3487/MEM 3454 in both of these debilitating diseases." The Phase 2 trial is in patients with stable schizophrenia who are receiving atypical antipsychotic therapy. Subjects in the study are randomized to receive 5 mg, 15 mg or 50 mg of R3487/MEM 3454 or placebo once daily for a period of ...

Olanzapine Long-Acting Injection (LAI) Shown to Maintain Treatment Benefit in Schizophrenia for up to Six Months

... LAI clinical trials was also presented at the meeting. Olanzapine LAI is an investigational formulation that combines Zyprexa(R) (olanzapine), an atypical antipsychotic, with pamoic acid resulting in a salt that sustains the delivery of olanzapine for a period of up to four weeks. Long-acting injectable ...

Seventy Years Old and Going Strong With Down Syndrome and No Dementia: The Case of 'Mr. C' Causes Major Interest in the Scientific Community

... 'Mr. C' does. That is, these previous cases did not have three complete copies of Chromosome 21 throughout all the cells in their bodies, but had an atypical Down syndrome genotype, explaining why they may have been less severely affected and why they had a higher life expectancy. However, 'Mr. C' is aging ...

Olanzapine Long-Acting Injection (LAI) Data Presented at First Annual Schizophrenia International Research Society Conference

... in patients treated with atypical antipsychotics, including olanzapine. While relative risk estimates are inconsistent, the association between atypical antipsychotics and increases in glucose levels appears to fall on a continuum and olanzapine appears to have a greater association than some other ...

Data Show Rufinamide, an Investigational Adjunctive Treatment for Lennox- Gastaut Syndrome, Reduced Drop Attacks by More Than 40%

... (between 4 and 30 years of age) were included if they had a diagnosis of inadequately controlled seizures associated with LGS (including both atypical absence seizures and drop attacks) and were being treated with 1 to 3 concomitant stable dose antiepileptic drugs (AEDs). Each patient must have had ...

Adding Breast Ultrasound Screening to Mammography Reveals Cancers not Seen on Mammography Alone in Women at Increased Risk for Breast Cancer

... for analysis. The criteria used to determine an increased breast cancer risk included: participant age of 25 years or older, dense breasts, prior atypical breast biopsy, personal and/or or moderate family history of breast cancer. The study was made possible through funding from a novel ...

Nventa Announces Additional Positive Immunological Data From HspE7 Phase 1 Cervical Dysplasia Trial

... estimated 1.2 million women are diagnosed with low grade cervical dysplasia (CIN 1), 300,000 with high grade dysplasia (CIN 2/3) and 2.4 million with atypical squamous cells of undetermined significance (ASCUS). No therapies other than surgery are currently approved by the FDA for the treatment of any type ...

Overview of Asenapine Data from Olympia Trial Program Presented at American Psychiatric Association Annual Meeting

... Kinon BJ. Discontinuation of treatment of schizophrenic patients is driven by poor symptom response: a pooled post-hoc analysis of four atypical antipsychotic drugs. BMC Med. 2005;3:21. Available at http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=16375765 . (Due to ...

Patients Treated with Risperidone Long-Acting Injection had a Significantly Longer Time to Relapse Compared to Quetiapine in International Clinical Study

... treated with risperidone long-acting injection (RLAI) had a significantly longer time to relapse (3) compared to patients treated with an oral atypical medication, quetiapine. The results were presented today for the first time at the American Psychiatric Association (APA) 161st Annual Meeting in ...

Nventa Announces Positive Interim Immunological Data From HspE7 Phase 1 Cervical Dysplasia Trial

... 1.2 million women are diagnosed with low grade cervical dysplasia, (CIN 1), 300,000 with high grade dysplasia (CIN 2/3) and 2.4 million with atypical squamous cells of undetermined significance (ASCUS). No therapies other than surgery are currently approved by the U.S. Food and Drug Administration ...

U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)

... diabetes mellitus -- Hyperglycemia, in some cases associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics including ABILIFY. Patients with diabetes should be monitored for worsening of glucose control; those with risk factors for ...

Memory Pharmaceuticals & Roche Expand Development Program for MEM 3454 in Schizophrenia

... of later-stage trials in schizophrenia." The biomarker study will enroll approximately 12 patients with stable schizophrenia who are receiving atypical antipsychotic therapy. Subjects will be randomized to receive MEM 3454 and placebo in a 5-way cross-over design. Each subject will participate in 5 ...

Intra-Cellular Therapies Presents Preclinical Data From Schizophrenia and Sleep Maintenance Programs

... reuptake site, an activity that potentially may be beneficial in treating affective disorders. ITI's CNSProfile(TM) has shown, unlike some atypical antipsychotics, ITI- 007 does not exhibit significant potency for a variety of other targets that have been implicated in a range of dose-limiting ...

Vanda Pharmaceuticals Receives FDA Acceptance of Iloperidone New Drug Application

... today that the U.S. Food and Drug Administration (FDA) has officially accepted the New Drug Application (NDA) for iloperidone, an investigational atypical antipsychotic for the treatment of schizophrenia. Acceptance of the NDA confirms that the application is sufficiently complete for FDA review. ...

Vanda Pharmaceuticals Reports Third Quarter 2007 Results

... September 27, 2007 Vanda announced that it had submitted an NDA to the U.S. Food and Drug Administration (FDA) for iloperidone, its investigational atypical antipsychotic for the treatment of schizophrenia. VEC-162 Vanda announced today the initiation of a Phase III clinical trial to evaluate the safety ...

INVEGA(TM) Significantly Reduced Symptoms of Schizophrenia Compared to SEROQUEL(R) in Acutely Ill, Hospitalized Patients

... Research & Development, LLC sponsored this clinical study. Additional details about the study are available upon request. INVEGA, an atypical antipsychotic medication, was first approved in the U.S. in December 2006. It is approved for the acute and maintenance treatment of schizophrenia in ...

Vanda Pharmaceuticals Submits Iloperidone New Drug Application

... announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for iloperidone, an investigational atypical antipsychotic for the treatment of schizophrenia. The application includes data from 35 clinical trials and more than 3,000 patients treated with ...

K-State Researchers Bringing Expertise to Kansas City Symposium on Disease and National Security

... understanding of prion diseases, especially bovine spongiform encephalopathy, or mad cow disease. He'll discuss the molecular features of typical and atypical cases of mad cow disease, the molecular nature of influenza virus evolution and will introduce a novel concept to vaccinate against influenza ....

Sarasota's Roskamp Institute Releases Study Defining a Mechanism for Development of Obesity and the Metabolic Syndrome, Forerunners of Type 2 Diabetes

... due to studies that suggest those who have diabetes are more likely to develop Alzheimer's disease. The study found that a deficiency in an enzyme, atypical protein kinase C, impairs the ability of insulin to stimulate glucose uptake into the muscle, which produces a state of resistance to circulating ...