Haloperidol News and Research

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Haloperidol is a typical antipsychotic. It is in the butyrophenone class of antipsychotic medications and has pharmacological effects similar to the phenothiazines.

Shionogi launches CUVPOSA for pediatric chronic severe drooling

Shionogi Inc., the U.S.-based group company of Shionogi & Co., Ltd., today announced the U.S. commercial availability of CUVPOSA™ (glycopyrrolate) oral solution, the first and only FDA-approved treatment to reduce chronic severe drooling in patients aged 3 to 16 with neurologic conditions associated with problem drooling, such as cerebral palsy.

7 Apr 2011

Hyperion HPN-100 phase III pivotal study for urea cycle disorders meets primary endpoint

Hyperion Therapeutics, Inc. today announced that the Company's phase III pivotal study of glycerol phenylbutyrate (HPN-100), an investigational drug for the treatment of urea cycle disorders (UCDs), met its primary endpoint. The non-inferiority study, conducted under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA) in June 2009, evaluated the ammonia control of glycerol phenylbutyrate as compared to sodium phenylbutyrate (BUPHENYL®).

3 Nov 2010

Common psychiatric drugs could slow dementia

Researchers say commonly used psychiatric drugs could be effective in slowing the progression of certain types of dementia. Dr John Kwok and colleagues from Neuroscience Research Australia have discovered a mutant gene that causes abnormal proteins build up in the brains of people with frontotemporal dementia, a disease that affects people in their 50s and 60s.

28 Oct 2010

Intra-Cellular Therapies demonstrates ability of ITI-002 to improve motor and non-motor behaviors in PD

Intra-Cellular Therapies, Inc. today announced results from studies demonstrating the anti-Parkinson and other beneficial effects of ITI-002 (IC200214), the Company's novel and selective phosphodiesterase type I (PDE1) inhibitor.

1 Oct 2010

Shionogi's CUVPOSA receives FDA approval for treatment of chronic severe drooling

Shionogi Inc., a U.S.-based group company of Shionogi & Co., Ltd., today announced the U.S. Food and Drug Administration approval of CUVPOSA™ (glycopyrrolate), the first liquid treatment for patients ages 3-16 who suffer from chronic severe drooling associated with neurologic conditions such as cerebral palsy. CUVPOSA™ was designated an Orphan Drug by the FDA.

30 Jul 2010

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

Merck announced that the Committee for Medicinal Products for Human Use adopted a positive opinion on the pending Marketing Authorization Application for SYCREST (asenapine) sublingual tablets. The CHMP has recommended that the European Commission grant a marketing authorization for SYCREST for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The CHMP did not support an indication for the treatment of schizophrenia.

25 Jun 2010

Novartis' Tasigna capsules granted priority review by FDA for treatment of adult patients with Ph+ CML

Novartis announced today that Tasigna® (nilotinib) 200 mg capsules has been granted priority review by the US Food and Drug Administration for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

19 Feb 2010

Tel Aviv University finds estrogen may protect women from psychosis

Many American women are prescribed estrogen to combat the negative effects of menopause, such as bone loss and mood swings. Now, new evidence from a Tel Aviv University study suggests that hormone replacement therapy might also protect them ― and younger women ― from schizophrenia as well.

21 Jan 2010

Hyperion Therapeutics commences enrollment in its HPN-100 episodic hepatic encephalopathy trial

Hyperion Therapeutics, Inc. today announced that the first patient has been enrolled in its phase II clinical trial of investigational compound HPN-100 (glycerol phenylbutyrate).

3 Dec 2009

New data demonstrating the strength of Novartis' hematology portfolio to be presented

Novartis announced today that new data, including a late-breaking presentation on Tasigna® (nilotinib) 200 mg capsules in a form of chronic myeloid leukemia, demonstrate the strength of the company's hematology portfolio in advancing the care of patients.

2 Dec 2009

Hyperion Therapeutics enrolls first patient in HPN-100 phase III clinical trial for urea cycle disorders

Hyperion Therapeutics today announced that the first patient has been enrolled in its pivotal phase III clinical trial of investigational compound HPN-100 (glycerol phenylbutyrate). The 4-week, multi-center, randomized, double-blind, cross-over study is designed to evaluate the non-inferiority of glycerol phenylbutyrate to BUPHENYL® (sodium phenylbutyrate) Tablets and Powder in adults with urea cycle disorders.

27 Oct 2009

Novartis' Tasigna capsules meets primary endpoint in comparison trial with Gleevec

Novartis announced today that Tasigna (nilotinib) 200 mg capsules met its primary endpoint in the first head-to-head comparison with the company's groundbreaking drug Gleevec (imatinib mesylate) tablets*. Tasigna produced faster and deeper responses than Gleevec when given as first-line therapy for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Tasigna was well tolerated in the study.

20 Oct 2009

Hyperion enrolls first patient in HPN-100 investigational compound clinical trial

Hyperion Therapeutics today announced that the first patient has been enrolled in a clinical trial of investigational compound HPN-100 (glycerol phenylbutyrate) in children ages 6-17 with urea cycle disorders (UCD). The study will evaluate the safety, tolerability, and ammonia control of glycerol phenylbutyrate compared to BUPHENYL® (sodium phenylbutyrate).

15 Sep 2009

Mylan receives FDA approval for additional strengths of antipsychotic Haloperidol

Mylan Inc. has announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for Haloperidol Tablets USP, 10 mg and 20 mg. These strengths are in addition to Mylan's currently marketed 0.5 mg, 1 mg, 2 mg and 5 mg strengths of the product.

20 Jul 2009

Antipsychotic drugs get FDA label changes

The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.

16 Jun 2008

Treatment with an anti-psychotic drug found to cause changes in metabolism earlier than expected

Schizophrenia is a complex type of psychotic mental illness characterized by thoughts that are uncoupled from reality.

8 Apr 2008

Aripiprazole has potential for treating alcohol dependence

Aripiprazole is currently approved to treat bipolar disorder as well as schizophrenia. A new study has found that it significantly and dose-dependently increases the sedative effects of alcohol and, to a lesser degree, decreases the euphoric effects of alcohol. Future research will need to examine the beneficial versus the side effects of aripiprazole for treatment of alcohol dependence.

4 Apr 2008

Haloperidol News and Research

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