Home Politics Religion Media Biz Society Tech Travel Books Intl. Autos Automobiles
                        Aviation   Pharma   About Us   Feedback   Links

Investigational drug for Acute Bipolar Mania And Schizophrenia

New Investigational Data Using Intramuscular Administration Of Aripiprazole In Patients With Acute Bipolar Mania And Schizophrenia



ATLANTA, GEORGIA (May 25, 2005) - In two double-blind, randomized, multicenter studies reported this week at the 158thAnnual Meeting of the American Psychiatric Association, data were presented on the investigational use of intramuscular (IM) aripiprazole in patients with either acute bipolar mania or schizophrenia. The primary efficacy measure for both studies was mean change from baseline to two hours post-initial IM injection, in the Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) score: poor impulse control, tension, hostility, uncooperativeness and excitement.

In these studies, the first injection was followed by inpatient evaluation for 24 hours. If needed, a second injection was given at least two hours post-initial injection and a third injection, if needed, at least two hours post-second injection. For the placebo group, the third injection contained aripiprazole IM 10 mg.

Detailed Study Information:
Intramuscular Aripiprazole or Lorazepam versus Placebo for Agitation in Acute Mania

This double-blind, randomized, multicenter study compared two investigational doses of IM aripiprazole (10 mg and 15 mg), and IM lorazepam (2 mg) with placebo. Mean changes from baseline in PEC scores two hours after the initial IM injection were aripiprazole 10 mg (n=75), -8.7; aripiprazole 15 mg (n=75), -8.7; lorazepam 2 mg (n=68), -9.6; placebo (n=73), -5.8 (for all active drugs p-value was less than 0.001 versus placebo).

In this study, the most commonly reported adverse events for either dose of aripiprazole occurring in frequency greater than five percent were nausea, vomiting, headache, somnolence, sedation, dizziness and insomnia.

"Patients experiencing acute agitation in bipolar disorder can be highly distressed and require treatment that works quickly," said Gary Sachs, MD, Associate Professor of Psychiatry, Harvard Medical School, Director of the Bipolar Clinic and Research Program, Massachusetts General Hospital. "These data provide important information about the potential use of intramuscular medicine in this patient population."

Intramuscular Aripiprazole or Haloperidol versus Placebo in Acute Schizophrenia: A Pivotal Phase III Study

In the second double-blind, multicenter investigational trial, acutely agitated patients with schizophrenia and schizoaffective disorder were randomized to IM aripiprazole (10 mg), IM haloperidol (6.5 mg) or IM placebo in a 2:2:1 fashion. Mean changes from baseline in PEC scores two hours post-initial IM injection were aripiprazole (n=173), -7.3; haloperidol (n=184), -7.8; and placebo (n=88), -4.8 (p-value less than 0.001 for both drugs versus placebo).

The most commonly reported adverse events for aripiprazole in this study, occurring in frequency greater than or equal to five percent were headache, dizziness, nausea and insomnia.

Aripiprazole is indicated for the treatment of schizophrenia including maintaining stability in patients who had been symptomatically stable on other antipsychotic medications for periods of three months or longer and observed for relapse during a period of up to 26 weeks. Aripiprazole is also indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder. Most recently, in March 2005, aripiprazole was FDA-approved for maintaining efficacy in patients with Bipolar I Disorder with a recent manic or mixed episode who had been stabilized and then maintained for at least six weeks. Physicians who elect to use aripiprazole for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Since its initial approval in 2002, over 3.7 million prescriptions have been written in the United States. i

Aripiprazole is available by prescription only. In addition to administration as a once-daily tablet, aripiprazole was recently FDA-approved in a 1 mg/mL oral solution. Aripiprazole Oral Solution is an important new treatment option for adult patients who are unable to or have difficulty swallowing tablets, and provides flexibility in addressing individual patient needs. Patients should talk to their healthcare provider for more information. To learn more about aripiprazole and for full product information, please visit www.bms.com .


Pharma News Headlines

Cancer News

Cardiac News


Pharma industry news


Roche, Novartis lead on novel cancer therapies

US FDA grants fast track status for GSK’s HIV drug

Stem Cell Bill could be delayed in US

FDA warning on abortion drug Mifeprex (Mifepristone)

US FDA recalls Baxter’s intravenous pumps

US FDA grants tentative nod to Ranbaxy’s glimepiride

Lupin launches generic ceftriaxone in US

Hormonal contraceptives safe for long-term use: WHO

Abortion pill to carry 'black box' warning

Vaccines not linked to autism, say experts

Novartis acquires Bristol-Myers’ OTC business in US

Guidant alerts on flaw in pacemakers

Awareness on Medicare drug benefit scheme low in US

NIH review finds govt scientists having ties with pharma firms

US FDA to decide on Plan B morning-after pill by Sept 1

Painkiller patch Duragesic under US FDA probe over patients deaths

Legionnaire's disease outbreak in US hospital in New Rochelle 

Genepharm in pact with 3 Australian distributors 

UK has new generics reimbursement scheme 

Teva gets US FDA nod for mirtazapine anti-depressant 

US patent office rejects Pfizer’s Lipitor claims 

Aethlon Medical to start trials on HIV device in India 

Panel to decide fate of Advair, Serevent and Foradil asthma drugs 

Prohibitive costs mar cancer therapy 

FDA directs Palladone withdrawal

Blindness alert on impotence drugs  

Novartis files for breast cancer drug in US, Europe  

Merck readies for $10 billion Vioxx battle  

Speak up on menopause, campaign urges US women 

Direct-To-Consumer ads mislead patients: US Senator  

EU to decide on sops for developing kids drugs  

Zidovudine by Ranbaxy gets US FDA tentative nod

Parkinson's Disease therapy triggers gambling in some patients

Parkinson's Disease symptoms may be relieved by Azilect

Are obesity and diabetes just accelerated aging?

Reducing lung infection and inflammation due to Cystic Fibrosis

Viruses may help cure cancer by killing cancer cells

New product relieves tooth pain resulting from dental sensitivity 

Cervical Cancer detector may improve on Pap Smears

Dietary supplement capsule by Liqing banned in US

Cold Stone Creamery cake batter ice-creams recalled

Guidant defibrillator recall: US FDA makes three classifications

AIDS drug stavudine by Aurobindo Pharma gets tentative US FDA approval for PEPFAR

Gates Foundation donates for a good cause

Paxil CR resupply in US pharmacies announced by GlaxoSmithKline

Viagra users not at risk of blindness: Pfizer

Stem cell research gets boost from Li Ka-shing

BiDil heart failure drug for black patients approved

Restless leg syndrome could be messing up your sleep

Glaxo Smithkline in pact with IAVI to develop AIDS drug

Pfizer acquires Vicuron Pharma for $1.9 billion

German Remedies launches Fludara Oral

Ranbaxy acquires generic product portfolio from Efarmes

Sandoz files seven ANDAs of drugs going off-patent

Elder Pharma plans unit, brand acquisition

Novasite Pharma buys PsyCheNomicS

Chemokine gets US patent for novel cancer drug

Roche gets USFDA approval for oral Xeloda

Nectar Lifesciences plans Rs 90 crore IPO 

Glaxo inks co-promotion pact with Eisai for Paritec

Early Intervention required to Prevent Diabetes

AIDS drug ahoy!

Novartis launches AMD patient counselling programme

Nanobac Life Sciences, UCSF to study kidney stones 

Surface Logix commences phase I trial for PDE-5 inhibitor

Temasek sets up $112 million pharma JV

Contraceptive from Neem, courtesy DRDO  

US FDA to source anti-HIV drugs from Indian firms  

Chemists boycott Glaxo, Novartis products  

Maharashtra phases out nerve tissue-based rabies vaccine  

Last long, really long - new sex drug soon  

Johnson and Johnson demonstrates coronary stent safety

Novartis has better breast cancer treatment

Pfizer's investigational drug reduces tumor growth

New labeling for beta-blocker Coreg 

Glaxo applies for FDA approval for Flaurix

Investigational drug for Acute Bipolar Mania And Schizophrenia

Preclinical Data Support Link Between IL-9 and Airway Hyperresponsiveness Associated With Asthma



Home Politics Religion Media Biz Society Tech Travel Books Intl. Autos Automobiles
                        Aviation   Pharma   About Us   Feedback   Links

Latest updates    Contact Us - Feedback    About Us