Magazine article Drug Topics

Schizophrenia Drug Approved but with a Name Change

Magazine article Drug Topics

Schizophrenia Drug Approved but with a Name Change

Article excerpt

Pfizer Inc.'s new schizophrenia therapy got the Food & Drug Administration's go-ahead earlier this month, but federal regulators nixed the drug's proposed brand name and raised a caution flag about potential heart risks.

Ziprasidone HCl is a novel antipsychotic drug for the treatment of schizophrenia. It is a serotonin and dopamine antagonist indicated for treating the positive and negative symptoms associated with the condition, including visual and auditory hallucinations, delusions, lack of motivation, and social withdrawal.

Although the FDA found ziprasidone to be effective, the agency issued a warning that the drug may cause long QT interval, which raises the possibility of dangerous irregular heartbeats and sudden death. The agency, however, did not require a black box warning or that patients undergo electrocardiograms at initiation of therapy or during the course of treatment. The decision of whether to prescribe ziprasidone or another antipsychotic agent as first-line therapy was left to the physician's best professional judgment.

Pfizer had sought to market the new drug under the brand name Zeldox. But the FDA decided that name was too similar to other drugs, such as Zyvox, already on the market, which could lead to medication errors stemming from look-alike or sound-alike drug names. Although the FDA found its alternative name of Geodon acceptable, Pfizer has not officially selected a new name for the drug.

Ziprasidone was the subject of worldwide clinical trials that enrolled 4,500 patients, the largest ever conducted for an antipsychotic medicine prior to introduction, according to Pfizer. In placebo-controlled, shortterm clinical trials, ziprasidone 20 mg to 100 mg twice daily was statistically superior to placebo for treatment of schizophrenia and schizoaffective disorder. A one-year, placebo-controlled study in chronic, stable inpatients found that ziprasidone was effective in delaying the time to and rate of relapse. …

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