Zeldox ® receives European approval for the treatment of bipolar disorder in children and adolescents.

According to the procedure of mutual recognition European.

– the new indication will be made effective in 12 European countries, which include Spain.

– En Spain is estimated that some 800,000 people could suffer this disorder throughout his life.

– particularly in the last years of adolescence or in the early-age adult.

Madrid, September 2009.- The Swedish Medicines Agency (MPA, its acronym in English) has approved ziprasidone (Zeldox ®) for the treatment of moderately manic or mixed episodes associated with bipolar disorder in children and adolescents aged 10 to 17. The procedure of European mutual recognition, in which the Swedish Agency acting as reference Member State, has been completed, so the approval in the rest of the 12 European countries will arrive soon.

The adoption of the Swedish Agency of medicinal products is based on the results of a double blind study of 4 weeks, placebo-controlled and in which participated 237 patients aged 10 to 17 years diagnosed with bipolar disorder. The study shows that ziprasidone is an effective treatment for the symptoms of bipolar mania and with a profile similar to the adult safety in children. The majority of patients who received ziprasidone experienced a neutral effect on the body weight on both parameters metabolic, including glucose and lipids.

” Bipolar disorder in young people is a priority health issue for the potential impact on the life of a child or adolescent, as well as their families ” pointed out the Dr. Juan Álvarez, Director of the unit medical of Pfizer. addition, there are few treatments for this disease so that this new therapeutic optionIt allows to treat the symptoms of bipolar disorder, it will help children and their families better cope with this disease ”.

Spain estimates that around 800,000 people could suffer from this disorder throughout his life and that if left untreated can affect substantially both in family and social spheres and in the labour.

Bipolar disorder is a serious mental illness characterized by abrupt changes in the State of mood and behavior, affecting especially in late adolescence or early adulthood. When the disease occurs in children or young adolescents is called bipolar illness for home early. In adolescents, the fluctuations of mood, which alternate with maniacs and depressive, episodes are characterized by euphoria, unrealistic increases in self-esteem, and decreased sleep, along with a high-risk behaviors such as alcohol, drug abuse, reckless driving and sexual promiscuity.

With more than seven years of experience, ziprasidone is available in 77 countries around the world. In the European Union, ziprasidone has already been approved for the treatment of adults with schizophrenia and manic or mixed episodes of bipolar disorder treatment. The procedure of European mutual recognition, whereby Zeldox ® has been approved to treat bipolar mania in children and adolescents, applies in the following countries: Spain, Austria, Denmark, Finland, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Norway, Portugal and Sweden.

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