The new drug, Invega (paliperidone), is an extended-release tablet being manufactured by ALZA Corp. in Mountain View, CA for Janssen, L.P. in Titusville, NJ.
Invega is a very new medication in that it contains an active substance that the U.S. has never approved before for marketing in any format prior to the approval for this application.
Schizophrenia is a mental illness that is uncurable, but sometimes successfully treatable. Depending on the intensity of the illness, the patient may suffer with symptoms ranging from being totally delusional to having hallucinations to having an inability to function socially or follow instructions. The patient may suffer from some or all of these symptoms, and the caregivers or family members usually suffer along with the patient as well.
Oftentimes people who display the severe form of this chronic mental disorder appear to be talking to an imaginary person and/or show no emotions whatsoever.
According to the Deputy Director of the FDA's Center for Drug Evaluation and Research, Douglas Throckmorton, MD, stated, "Schizophrenia can be a devastating illness requiring lifelong medication and professional counseling. Today's approval adds to the treatment options for patients with this condition."
The short-term three six-week placebo-controlled trials for Invega took place in North America, Europe and Asia. There were 1,665 adults who participated in the evaluation for the study trial. The results indicated that the effectiveness of the drug for relieving symptoms of schizophrenia was superior to the placebo treatment.
Invega may be prescribed by a doctor in different dosages.
Although the trials were not long-term, the patients who are able to tolerate this drug for any extended period should continue to be monitored periodically.
The possible side effects indicated by the study included restlessness, movement disorders, rapid heart beat and sleepiness.
Invega is an atypical antipsychotic. There is the risk of an increased rate of death with the elderly patient who has dementia-related psychosis. According to the FDA, Invega is not approved for dementia-related psychosis.
Schizophrenia is a brain disease that typically begins in early adulthood between the ages of 15 and 25, according to schizophrenia.com. Men tend to develop the illness just slightly earlier than women. The earlier the diagnosis is made, the earlier the treatment, and then the better the final outcome.
Approximately 2.2 million people suffer from schizophrenia in the U.S. from a total of 51 million people worldwide.
