Pfizer’s Zeldox gets European green light

Pfizer yesterday announced that its atypical antipsychotic Zeldox (ziprasidone HCl) treatment received approval in 11 European Union member states and two EU observer countries.

Zeldox, marketed as Geodon in the United States, is used for the treatment of manic or mixed episodes of moderate severity in bipolar disorder.

Bipolar disorder is a common and serious psychiatric condition characterised by severe mood swings ranging from depression to persistently elevated, expansive or irritable moods.

In tests Zeldox was shown to rapidly improve acute manic symptoms and to sustain these improvements over a 12-week study period while no significant adverse effects on weight, cholesterol or triglycerides were seen.

Discovered and developed by Pfizer, Zeldox/Geodon is a serotonin and dopamine antagonist and its approval in Europe follows approval given by the US Food and Drug Administration (FDA) last August.

The European approval is based on data from three short-term placebo-controlled clinical studies involving 853 patients.

The most common adverse effects in the studies were somnolence, dizziness, akathisia and extrapyramidal symptoms.

The recommended dose for treating adult bipolar mania with Zeldox capsules is 40 mg to 80 mg twice a day, the same dose used in treating schizophrenia in adults.

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