New Schizophrenia Drug Approved in the U.S.

U.S. Food and Drug Administration (FDA) has approved Invega (paliperidone) for treating schizophrenia. Invega is a first-in-class (new molecule drug), which this is the first drug of its kind in the therapeutic category. Invega is an active metabolite of a drug already available for treating schizophrenia, risperidone. Common side effects included the following: Restlessness, Extrapyramidal symptoms (movement disorders), Rapid heart beat, and Sleepiness.

You may have first read about this drug in clinical trials here on the Mental Health Source Page. According to the FDA, it approved Invega based on 3 placebo-controlled clinical trials conducted for 6 weeks in North America, Europe and Asia and involving 1665 adult patients / human subjects. Based on clinical trial results, recommended dose range of Invega is 3mg to 12 mg a day.

Invega is also an atypical antipsychotics that have an increased rate of death compared with placebo in elderly patients with dementia-related psychosis, as its official website and drug label is required to disclose:

IMPORTANT SAFETY INFORMATION FOR INVEGA™
Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. INVEGA (paliperidone) is not approved for the treatment of patients with Dementia-Related Psychosis.

Since the drug’s clinical trials spanned 6 weeks, Invega has not been studied in controlled clinical studies longer than 6 weeks, which means patients taking this drug for more than 6 weeks (more than 1.5 months) should be periodically checked by a doctor.

You may learn more about Invega at its official website or visit the FDA website for the original approval press release.

December 22, 2006 | Filed Under Treatment 

Comments

2 Responses to “New Schizophrenia Drug Approved in the U.S.”

  1. Sunshine Folsom on May 15th, 2007 5:47 pm

    HI I am just wondering if anyone has taken invega are there really sexual side effects or not. I am hearing that their isnt but it is listed as a side effect. Any experience would be great.

  2. Jane Chin, Ph.D. on May 22nd, 2007 1:50 pm

    You may want to try this site:

    http://www.askapatient.com/index.asp

    I queried for Invega, but didn’t come up with any hits (may be still too new at this point). It was mentioned in a rating for Risperdal, though:

    http://tinyurl.com/2afebe

    Jane

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