FDA OKs New Schizophrenia, Bipolar Drug

Saphris

A new drug, called Saphris, has been approved by the Food and Drug administration (FDA) for the treatment of schizophrenia and bipolar I in adults.

A clinical study involving more than 3,000 patients with acute schizophrenia or bipolar mania, followed for as long as two years led to FDA's decision to approve this drug.

Hearing voices or seeing things that are not there, having false beliefs (for example, believing that others are controlling thoughts, reading minds, or plotting harm), and being inappropriately suspicious or paranoid are the most common symptoms of schizophrenia.

Some of the symptoms of the recurrent psychiatric disorder, bipolar I disorder, are alternating periods of depression and high, increased activity and restlessness, racing thoughts, fast talking, impulsive behavior, and a decreased need for sleep.

Saphris, comes under the class of drugs called antipsychotics and is made by the company, Schering-Plough. FDA gave a nod to this drug since it was better than a placebo at treating symptoms of bipolar disorder.

A 'BlackBox' warning has been issued against all antipsychotic drugs to alert the users about the high risk of death related to off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis. Saphiris is not approved for such patients.

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