FDA Advisory Committee Votes in Favor of SAPHRIS(R) (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia
... of manic or mixed episodes associated with
bipolar I disorder in adults and in favor of use in acute ... unmet need for patients with schizophrenia and
bipolar I disorder, including patients starting treatment ... and safe (12/0/0 and 10/0/2) for the
bipolar I disorder and schizophrenia indications, ...
FDA Advisory Committee Votes in Favor of Zyprexa for Two Adolescent Indications
... or manic or mixed episodes associated with
bipolar I disorder in adolescents aged 13-17 years old. ... for manic or mixed episodes associated with
bipolar I disorder, the panel voted 17-0, with one ... of Zyprexa in adolescents with schizophrenia or
bipolar I disorder, including a six-week double-blind, ...
RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder
... to relapse compared to placebo in patients with
bipolar I Disorder. Results of the study were presented this week at a major medical meeting.
bipolar Disorder is a brain disorder that causes unusual ... (mania) to extreme lows (depression). Type I
bipolar Disorder is characterized based on the occurrence ...
Cephalon Announces Positive Results From a Phase Two Study of NUVIGIL in Bipolar Depression
... treating major depressive disorder in adults with
bipolar I disorder. An estimated two million American adults are affected by
bipolar I disorder, which is characterized by ... and lows (depressed) in mood. People with
bipolar disorders cycle between periods of manic or ...
Study Suggests New Treatment Approach May be Needed for Management of Depression in Some People With Bipolar Disorder
... to identify what factors make some people with
bipolar depression more likely to experience treatment-emergent mania (TEM).
bipolar disorder, also known as manic-depressive illness, ... earlier study led by Robert Post, M.D., and the
bipolar Collaborative Network. In that earlier study, ...
Intra-Cellular Therapies Announces Successful Outcome of a Phase II Clinical Trial with ITI-007 in Patients with Sleep Maintenance Insomnia
... various patient populations including depression,
bipolar disorder, Alzheimer's disease, mild cognitive ... many neuropsychiatric (e.g. major depression,
bipolar disorder, PTSD, mild cognitive impairment and ... disruption is common in patients with depression,
bipolar disorder and other mood disorders, Alzheimer's ...
FDA Issues a Complete Response Letter for Lilly's Olanzapine LAI for Treatment of Schizophrenia in Adults
... schizophrenia, acute mixed and manic episodes of
bipolar I
disorder, and maintenance treatment of
bipolar disorder.
Olanzapine is not approved for ... placebo-controlled, short-term schizophrenia and
bipolar mania
trials was somnolence. Other common events ...
Alexza's AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial
... 3
clinical trial was conducted in patients with
bipolar disorder experiencing
acute agitation. Both the ... including schizophrenia and
bipolar disorder. Patients
experiencing agitation become ... afflicts about 2.5 million adults and
bipolar disorder
affects about 6 million adults. The ...
Forest Laboratories, Inc. and Gedeon Richter Plc Announce Positive Phase II Results with the Investigational Antipsychotic Cariprazine in Patients with Acute Mania Associated with Bipolar I Disorder
... in patients with
acute mania associated with
bipolar I disorder. For the primary endpoint,
the Young ... exciting preliminary results in patients with
bipolar mania
demonstrate the potential of cariprazine as ... patients with acute mania associated with
bipolar I disorder. During the
five week study, 236 men ...
Alexza's AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients
... acute agitation in patients with
schizophrenia or
bipolar disorder. AZ-004 is being developed ... believes that many patients with
schizophrenia or
bipolar disorder can make informed decisions ... initiated a
second Phase 3 clinical trial in
bipolar disorder patients with acute
agitation.
About ...
Alexza Reports 2008 Second Quarter Financial Results and Updates Development of Product Candidates
... treatment
of acute agitation in schizophrenic or
bipolar disorder patients," said
Thomas B. King, ... enroll approximately 300 patients diagnosed with
bipolar I
disorder and acute agitation at 18 U.S. ... This study is the first AZ-004 study
enrolling
bipolar disorder patients. The Company projects that this ...
Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
... acute agitation in patients with schizophrenia or
bipolar disorder.
Alexza believes the novel, non-invasive ... enroll
approximately 300 patients diagnosed with
bipolar I disorder and acute
agitation at 18 U.S. ... believes that many patients with
schizophrenia or
bipolar disorder can make informed decisions ...
Olanzapine Long-Acting Injection (LAI) Data Presented at First Annual Schizophrenia International Research Society Conference
... acute mixed and manic episodes of
bipolar disorder, and
maintenance treatment of
bipolar disorder. In Europe, olanzapine is
indicated for ... for the prevention of recurrence in patients
with
bipolar disorder.
Since olanzapine was introduced in ...
Repligen Announces Plans to Initiate a Phase 2b Trial for RG2417 in Bipolar Disorder
... Gary S. Sachs, M.D., founder and director
of the
bipolar Clinic and Research Program at the Massachusetts ... 2a
clinical trial of RG2417 in patients with
bipolar disorder. We have now
completed our assessment of ... reflect the difficulty in accurately diagnosing
bipolar disorder
in the absence of frequent ...
NARSAD Researchers Identify Specific Genes and Family Traits Linked to Schizophrenia, Bipolar Disorder and Depression
... illnesses, such as schizophrenia,
bipolar disorder and
depression.
To be presented at ... susceptibility to and
pathology of schizophrenia,
bipolar disorder and depression, some of the
most severe, ... are
carriers of the genes for schizophrenia and
bipolar disorder, even though
these individuals don't ...
Overview of Asenapine Data from Olympia Trial Program Presented at American Psychiatric Association Annual Meeting
... treatment of schizophrenia and
bipolar I disorder
WASHINGTON, May 8 ... Data from
the studies, involving patients with
bipolar I disorder and schizophrenia,
were presented in ... was shown to be effective in two
short-term
bipolar mania studies with a nine-week extension and in ...
New Data on SEROQUEL XR(TM) in Treatment of Both Major Depressive Disorder and Generalized Anxiety Disorder Presented at APA Annual Meeting
... of quetiapine is approved for the
treatment of
bipolar depression. (See Boxed Warning.)
Hyperglycemia, ... in MDD is
similar to a depressive episode of
bipolar disorder with the major
distinguishing feature ... been reported that 69 percent of
patients with
bipolar disorder were misdiagnosed, with the most ...
UBC Forms European Advisory Board to Enhance Data Quality of CNS Trials
... president of the International Society of
bipolar Disorder (ISBD).
-- Cyril Hoschl, MD, DSc., ... Professor of Psychiatry and Director of the
bipolar Disorders Program of the Hospital Clinic at the ... of Neuroscience and he currently leads the
bipolar Research Program at the Spanish Research Network ...
Statement from Eli Lilly and Company: Response to Connecticut Attorney General News Release
... of the
seriousness of schizophrenia or
bipolar disorder, no reference to the
importance of ... schizophrenia, acute mixed and manic episodes of
bipolar I
disorder, and maintenance treatment of
bipolar disorder. Since Zyprexa was
introduced in 1996, ...
Alexza's AZ-104 (Staccato(R) Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migraine Headache
... acute
agitation in patients with schizophrenia or
bipolar disorder. AZ-004 and
AZ-104 are being developed ... acute agitation in patients with
schizophrenia or
bipolar disorder.
About Symphony Allegro
In December ... treatment of acute
agitation in schizophrenic or
bipolar disorder patients, is in Phase 3
testing. AZ-001 ...
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)
... of manic and mixed episodes associated with
bipolar I
Disorder, with or without psychotic features in ... of manic and mixed episodes associated with
bipolar I Disorder
with or without psychotic features in ... 2004 and March
2005, respectively.
"Pediatric
bipolar illness is a serious condition," said ...
Positive Results Published Using AtriCure Minimally Invasive Products
... procedure using the
AtriCure minimally invasive
bipolar ablation system. Additionally, in 21 of
the 22 ... surgeons of the AtriCure Isolator(R)
bipolar ablation clamps
as a treatment alternative during ... The FDA has cleared the AtriCure Isolator(R)
bipolar ablation system,
including the new Isolator ...
AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression
... the treatment of manic
episodes associated with
bipolar disorder and the treatment of depressive
episodes associated with
bipolar disorder.
The
bipolar mania submission is based on a clinical study of ...
Schering-Plough Announces Asenapine NDA Accepted for Filing by the U.S. FDA
... and acute mania or mixed episodes associated with
bipolar I
Disorder. In accepting the NDA, the FDA ... Organon
BioSciences on November 19, 2007.
About
bipolar Disorder
bipolar Disorder, commonly referred to as ...
SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia
... in 77 countries for the treatment of
bipolar mania, and in
11 countries including the U.S. for the treatment of
bipolar depression.
SEROQUEL XR was launched for the ... for the treatment of depressive
episodes in
bipolar disorder; acute manic episodes ...
Repligen Reports Positive Phase 2a Clinical Trial Results of RG2417 for Symptoms of Bipolar Disorder
... and efficacy of RG2417 on the symptoms of
bipolar depression as
measured by the co-primary ... of funding for
research on schizophrenia and
bipolar disorder in the United States. "We are pleased ... in the
design of future clinical studies." About
bipolar Disorder ...
Large Controlled Trial of Widely Used Mood Stabilizers Demonstrates Efficacy in Pediatric Bipolar Disorder
... for
children and adolescents diagnosed with
bipolar disorder," said Robert A.
Kowatch, M.D., Ph.D., a ... acute efficacy results from the
Pediatric
bipolar Collaborative Mood Stabilizer Trial, which also ... for another 16 weeks. The classic form of the
bipolar illness, also know ...
Alexza Reports 2009 First Quarter Financial Results and Updates Clinical Pipeline Status
... for the acute treatment of agitation in patients with schizophrenia or
bipolar disorder. The Company projects an NDA submission for AZ-004 in the first ... being developed for the acute treatment of agitation in schizophrenic or
bipolar disorder patients. Alexza has completed and announced positive results ...
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and INVEGA(R)
... schizoaffective disorder is sometimes misdiagnosed as schizophrenia or
bipolar disorder. For patients who frequently use mental health services, ... markets prescription medications for the treatment of schizophrenia,
bipolar mania and the treatment of symptoms associated with autistic disorder. ...
Omeros Receives $3.1 Million Milestone Payment from The Stanley Medical Research Institute for Schizophrenia Program
... that supports research on the causes and treatment of schizophrenia and
bipolar disorder (manic-depressive illness), both through work carried out in its ... has provided over $200 million in funding since 1989. Schizophrenia and
bipolar disorder are major psychiatric disorders in the United States, affecting ...
Alexza Initiates AZ-104 (Staccato(R) Loxapine) Phase 2b Clinical Trial in Patients With Migraine Headaches
... for the acute treatment of agitation in patients with
schizophrenia or
bipolar disorder. The Company has previously announced
positive results in two ... being developed for the acute
treatment of agitation in schizophrenic or
bipolar disorder patients. Alexza
has completed and announced positive initial ...
U.S. FDA Issues Complete Response Letter for SAPHRIS(TM) (ASENAPINE) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder
... and in the acute treatment of manic or mixed episodes associated with
bipolar I disorder in adults as monotherapy. The action letter includes proposed ... trial program involving more than 3,000 patients in schizophrenia and
bipolar mania trials.
Schering-Plough is an innovation-driven, ...
Schering-Plough Unveils Top-Line Study Results for SAPHRIS(TM) (asenapine) Demonstrating Efficacy in Long-Term Schizophrenia Relapse Prevention
... of schizophrenia, and treatment of manic episodes associated with
bipolar 1 disorder. Asenapine is currently under review by the U.S. Food and Drug ... of schizophrenia and acute manic or mixed episodes associated with
bipolar I disorder. The company acquired asenapine in November 2007 through its ...
Study Suggests Treatment with Paliperidone ER Significantly Improves Symptoms of Schizoaffective Disorder
... disorder can be difficult to
distinguish from schizophrenia or
bipolar disorder because the symptoms are
similar to both. The disorder is about ... markets prescription medications
for the treatment of schizophrenia,
bipolar mania and the treatment of
symptoms associated with autistic disorder. For ...
Alexza Completes Enrollment in Phase 3 Clinical Trial with AZ-004 (Staccato(R) Loxapine) for Acute Agitation
... be similar to the
first trial, except that the patient population will be
bipolar disorder
patients.
Conference Call Information
The Company will host ... loxapine) for the treatment of acute
agitation in schizophrenic or
bipolar disorder patients, is in Phase 3
testing. AZ-001 (Staccato ...
Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder
... the treatment of acute agitation in patients with
schizophrenia or
bipolar disorder. Alexza will host an investor conference
call to discuss today's ... loxapine) for the treatment of acute
agitation in schizophrenic or
bipolar disorder patients, is in Phase 3
testing. AZ-001 (Staccato ...
AstraZeneca Submits sNDA for SEROQUEL XR(TM) for the Treatment of Generalized Anxiety Disorder - a First for the Atypical Antipsychotic Class of Medicines
... adult patients. SEROQUEL XR is currently not approved for
the treatment of
bipolar disorder. In January 2008, AstraZeneca announced
the submission of two ... an immediate release form of quetiapine is approved for the
treatment of
bipolar depression. (See Boxed Warning.)
Hyperglycemia, in some cases extreme ...
Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status
... the first trial, except that the patient population will be
patients with
bipolar disease. AZ- 004 is being developed through Symphony
Allegro, a product ... loxapine) for the treatment of acute
agitation in schizophrenic or
bipolar disorder patients, is in Phase 3
testing. AZ-001 (Staccato ...
Intra-Cellular Therapies Presents Data on Its Schizophrenia and Cognition in Schizophrenia Programs at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disorders
... given last week at the 14th Biennial
Winter Workshop on Schizophrenia and
bipolar Disorders. ITI-007 is
currently in Phase I clinical trials for the ... modulation for antipsychotic maintenance therapy and the treatment
of
bipolar disorders.
ITI-007 has a much lower propensity than several currently ...
FDA Advisory Committee Supports Efficacy and Safety of Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment
... mixed and manic episodes of bipolar
disorder, and maintenance treatment of
bipolar disorder. Since Zyprexa was
introduced in 1996, it has been prescribed to ... with
Zyprexa in placebo-controlled, short-term schizophrenia and
bipolar mania
trials was somnolence. Other common events were dizziness, weight ...