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Drug Zeldox for Treatment of Schizophrenia

Brand Name: Zeldox
Active Ingredient: ziprasidone
Indication: Treatment of schizophrenia
Company Name: Pfizer Inc
Availability: FDA Advisory Committee recommended drug for approval on July 20, 2000

ZeldoxIntroduction

Schizophrenia afflicts some one percent of the world’s population and requires lifelong treatment. In the US alone, the illness costs the country more than $104 billion in hospital costs, medications, health-care services, and lost productivity. The antipsychotic drugs currently used to treat schizophrenia, such as haloperidol, are associated with side effects such as tardive dyskinesia and weight gain. Drug Zeldox (ziprasidone) – that is just as effective as haloperidol but without the movement disorders and weight gain associated with currently available treatments.

Manufactured by Pfizer Inc., Zeldox received a recommendation for approval from an FDA Advisory Committee on July 20, 2000. It has been shown to be effective in treating a wide range of positive, negative, and depressive symptoms associated with schizophrenia, including visual and auditory hallucinations and delusions, blunted affect, social withdrawal, and lack of motivation.

How It Works

Zeldox works by antagonizing serotonin and dopamine in the nervous system.

Zeldox: Clinical Study Results

The efficacy of Zeldox for treating schizophrenia has been demonstrated in worldwide clinical trials of more than 4,500 patients.

Drug Zeldox for Treatment of SchizophreniaIn one study, 90 patients with schizophrenia or schizoaffective disorder received one of four doses of Zeldox (4 mg/day, 10 mg/day, 40 g/day, or 160 mg/day) or haloperidol 15 mg/day for 4 weeks. There was significantly greater improvement among the Zeldox groups in the Clinical Global Impression Severity (CGI-S) score but not the Brief Psychiatric Rating Scale (BPRS) total score.

BPRS total and Psychosis scores and CGI-S scores were comparable between the 160 mg Zeldox group and the haloperidol group and showed that Zeldox 160 mg/day and haloperidol were superior to Zeldox 4 mg/day. On all assessments of clinical efficacy, the improvements associated with Zeldox 4 mg/day, 10 mg/day, and 40 mg/day were similar. However, Zeldox had a lower potential to induce extrapyramidal symptoms than haloperidol.

Another study compared Zeldox 40 mg/day and 120 mg/day with placebo in 139 patients with an acute exacerbation of schizophrenia or schizoaffective disorder who were treated for 28 days. Zeldox 120 mg/day was significantly more effective than placebo in improving Brief Psychiatric Rating Scale (BPRS) total, CGI-S, BPRS depression cluster, and BPRS anergia cluster scores.

A third study compared Zeldox 80 mg/day and 160 mg/day with placebo in 302 patients with an acute exacerbation of schizophrenia or schizoaffective disorder who were treated for 28 days. Both doses of Zeldox produced significant improvements in psychological scale scores compared to placebo, and Zeldox 160 mg/day significantly improved depression symptoms in patients with clinically significant depression at baseline.

Adverse Events

The most common adverse events associated with Zeldox were mild dyspepsia, nausea, dizziness, headache, somnolence, and constipation. These side effects were generally of mild to moderate severity and rarely led to discontinuation of the drug.

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