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Clinical pharmacology review of escitalopram for the treatment of depression

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TAYLOR & FRANCIS LTD
DOI: 10.1517/17425255.2014.863873

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citalopram; depression; escitalopram; Food and Drug Administration; major depressive disorder; regulatory approval; selective serotonin reuptake inhibitor

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Introduction: Depression is a serious and debilitating psychiatric condition with serious societal health and economic implications. Escitalopram, the S-enantiomer of racemic citalopram, is an effective treatment for major depressive disorder. Areas covered: This review covers the clinical pharmacology of escitalopram, with emphasis on regulatory approval. Its pharmacokinetics, pharmacodynamics and clinical efficacy for major depressive disorder are evaluated, along with data regarding safety and tolerability. Expert opinion: Drug development of escitalopram was heavily guided by prior approval of citalopram. Select safety and efficacy studies for escitalopram in combination with supportive evidence from the results of prior citalopram studies allowed for regulatory approval for acute and maintenance claims in both adults and adolescents, while minimizing burden on the sponsor. Escitalopram has been shown to have better efficacy and safety profile than other selective serotonin reuptake inhibitor and serotonin norepinephrine reuptake inhibitor drugs, including racemic citalopram. The first generic escitalopram was approved in 2012, along with Abbreviated New Drug Applications. The associated cost savings have helped reduce the burden of weighing the benefits of escitalopram over less-expensive alternatives.

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