US drug giant Pfizer saw its shares inch up 1.1% to close at $21.74 following news that its atypical antipsychotic Zeldox (ziprasidone HCl) has received the green light in 11 European Union member states and two EU observer countries for the treatment of acute bipolar mania.
Zeldox is already sold in the 11 EU member states as a treatment for schizophrenia, and is marketed as Geodon in the USA, where it received its first regulatory nod for the condition in February 2001 [[19/02/1a]] and for this new use in August last year [[24/08/04b]].
Prompt and effective control of acute mania is an important treatment goal as patients are at a higher risk for impulsive and dangerous behaviours, often requiring psychiatric hospitalisation. Clinical studies to date have demonstrated Zeldox’ ability to rapidly improve acute manic symptoms and to sustain these improvements over a 12-week study period, the firm said.
In what may come to represent an important treatment advantage, clinical studies have revealed no significant adverse effects on weight, cholesterol or triglycerides with use of Zeldox, which are often associated with similar therapies. Pfizer is hoping that the agent’s beneficial profile in terms of weight gain will help it grab a larger stake of the market, which is still largely dominated by Eli Lilly’s Zyprexa (olanzapine).
Summing up the agent’s potential, Dr Joseph Feczko, Pfizer’s chief medical officer, said: "Zeldox provides rapid control of manic and mixed episodes in bipolar disorder and a favourable weight profile, which are highly valued by patients and the medical community."