New Medication Approved in the US for Schizophrenia

A November 1st posting by PsychCentral:

By Rick Nauert, PhD, Senior News Editor

Reviewed by John M. Grohol, Psy.D., on November 1, 2010

The U.S. Food and Drug Administration has approved Latuda (lurasidone HCl) tablets for the treatment of adults with schizophrenia.

“Schizophrenia can be a devastating illness requiring lifelong treatment,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research.

“Some patients do not respond well to certain types of drug therapy, so it is important to have multiple treatment options available.”

Latuda is included in the atypical antipsychotic class of drugs. All atypical antipsychotics contain a boxed warning alerting prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis.

No drug in this class is approved to treat patients with dementia-related psychosis.

Four six-week controlled studies of adults with schizophrenia demonstrated the effectiveness and safety of Latuda. In the trials, patients treated with Latuda had fewer symptoms of schizophrenia than those taking an inactive pill (placebo).

The most common adverse reactions reported by those in clinical trials were drowsiness, feelings of restlessness and the urge to move (akathisia), nausea, movement abnormalities such as tremors, slow movement, or muscle stiffness (Parkinsonism), and agitation.

Source: U.S. Food and Drug Administration

APA meeting 2009: new schizophrenia products and depot formulations

An article posted on May 31st by PipelineReview.com:

The annual meeting of the American Psychiatric Association is the year's largest psychiatry event. This year's conference in San Francisco indicated that long-acting depot versions of atypical antipsychotics continue to prove useful tools in the treatment of schizophrenia. In addition, new potential market entrants reported mixed data from new oral antipsychotics.

Although the majority of antipsychotics are now broadly used across most psychiatric conditions, the schizophrenia market continues to attract attention from developers of both novel antipsychotics and new formulations aimed at addressing the major unmet need of compliance.

The long-dosing regimen and intramuscular administration of long-acting injectable depot formulations of atypical antipsychotics results in a greater transparency of compliance. Eli Lilly presented new data for Zypadhera (olanzapine long-acting injection), as it continues to seek US approval and enter the market that Johnson & Johnson (J&J) has pioneered through Risperdal Consta (risperidone long-acting injection).

Data from new oral atypical antipsychotics were also presented. Vanda followed up the recent surprise approval of oral Fanapt (iloperidone) by presenting two posters detailing comparative data. Dainippon Sumitomo, meanwhile, provided delegates the first chance to see Phase III data for lurasidone.

To read the entire article, please click here.

Also see:

Newer Treatments for Schizophrenia: Benefits and Drawbacks

Schering asks EU to approve schizophrenia drug