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August 7th, 2009
US FDA Supports Antipsychotic Once-Monthly Invega Sustenna

The US FDA has recently approved Invega Sustenna extended-release injectable suspension for acute and maintenance therapy of adult schizophrenia.  Invega Sustenna is the first US approved once a month injectable, long-acting, atypical antipsychotic.  The Janssen sector of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will be responsible for the US marketing of Invega Sustenna.

Schizophrenia is a severe brain disorder that effects roughly one percent of the world’s population.  The disorder compromises a person’s capacity to think clearly, identify with others, and differentiate between fantasy and reality. Although there is no cure for Schizophrenia, symptoms and risk of relapse can generally be supervised with treatment that includes ongoing, long-term therapy and antipsychotic medications.

Studies show that 80 percent of schizophrenic patients will experience at least one relapse within five years of original diagnosis.  Patients who are treated using an oral atypical antipsychotic will fail to take their medication one-third of the year.  As a result, it is key for healthcare providers to assure that patients are engaging with their treatment course, to diminish the chance of relapse.

Psychiatry and Neuroscience professor and director at the University of Cincinnati College of Medicine, and a clinical investigators who worked on the Invega Sustenna trials, Henry A. Nasrallah, M.D., states that “Inconsistent compliance with medication is one of the single greatest impediments to managing the symptoms of schizophrenia and delaying relapse … the approval of once-monthly Invega Sustenna will provide healthcare professionals with a treatment option that is … a monitoring tool for uninterrupted medication compliance, which may help optimize clinical outcomes in schizophrenia.

The FDA endorsement is a result of four acute symptom control studies and a longer-term maintenance study that compared placebo to Invega Sustenna.  Invega Sustenna surpassed the placebo by progressing positive and negative syndrome scale total scores, and in the longer-term maintenance study delayed time to relapse.

During clinical trials, frequent side-effects included reactions at the site of injection, somnolence/sedation, dizziness, akathisia and extrapyramidal disorder.

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