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Published on 29 July 2009

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Psychiatric drug nears approval

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US health chiefs have said that an experimental psychiatric drug appears to be a safe and effective treatment for people suffering from schizophrenia and bipolar disorder.

The Food and Drug Administration (FDA) said that Saphris, from health care firm Schering-Plough, appears to be as safe as other drugs in the class, known as atypical antipsychotics. The regulator, however, has not yet reached a final decision on the drug.

A panel of independent experts in the field of psychiatry will vote whether the FDA should approve the drug. The agency does not have to follow the panel’s guidance but it usually does.

Schering-Plough held four studies into the effects of Saphris on schizophrenia patients. Two of the studies produced positive results, according to the FDA. It also studied the drug in two trials of bipolar patients, both of which showed positive results.

The drug’s most common side effects emerged as sleepiness, restlessness, dizziness and weight gain.

If approved, Saphris would enter the market occupied by already established products such as AstraZeneca’s Seroquel and Eli Lilly’s Zyprexa, both of which are already approved for schizophrenia and bipolar disorder.

Copyright Press Association 2009

Food and Drug Administration



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