Vilazodone
| Autor: | Issam Zineh, Robert Temple, Phillip V. Dinh, Sue-Jane Wang, Li Zhang, Mitchell V. Mathis, Cheri Y. Lindberg, Ellis F. Unger, Peiling Yang, Violetta Klimek, Robert L. Levin, Jee Eun Lee, Yaning Wang, Huixia Zhang, Linda Fossom, Atul Bhattaram, H. M. James Hung, Bei Yu, Thomas Laughren, Barry N. Rosloff, Jogarao V. S. Gobburu |
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| Rok vydání: | 2011 |
| Předmět: |
Male
Drug medicine.medical_specialty Indoles media_common.quotation_subject Vilazodone Hydrochloride Clinical Trials Phase IV as Topic Piperazines law.invention chemistry.chemical_compound Clinical Trials Phase II as Topic law Internal medicine Vilazodone Humans Medicine Adverse effect Psychiatry Drug Approval Benzofurans media_common New drug application Depressive Disorder Major Clinical pharmacology United States Food and Drug Administration business.industry United States Clinical trial Sexual Dysfunction Physiological Psychiatry and Mental health Clinical Trials Phase III as Topic chemistry Antidepressant Female business Selective Serotonin Reuptake Inhibitors |
| Zdroj: | The Journal of Clinical Psychiatry. 72:1166-1173 |
| ISSN: | 0160-6689 |
| Popis: | Objective Vilazodone was recently approved by the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD). The purpose of this review is to summarize the FDA's approach to its review of the clinical pharmacology and the clinical efficacy and safety data for this new drug application, important issues in its decision-making, and its conclusions. Data sources The data sources for this review were the original raw data sets for all clinical trials included in the development program for vilazodone, as well as the sponsor's original analyses of these data. Study selection Data were available from 24 human trials involving vilazodone, and included a total of 2,898 human subjects exposed to 1 or more doses of this drug. Data extraction The FDA had access to original raw data sets for these trials. Results Vilazodone is effective in treating MDD at a dose of 40 mg/d, but it needs to be incrementally adjusted to this dose to minimize gastrointestinal symptoms. It needs to be taken with food to ensure adequate plasma concentrations. Vilazodone's profile of adverse events is similar to that seen with selective serotonin reuptake inhibitors. No dose adjustment is needed based on age, gender, or renal or hepatic impairment. It is recommended that the vilazodone dose be reduced to 20 mg when it is taken with strong cytochrome P450 (CYP) 3A4 inhibitors, eg, ketoconazole. Vilazodone is not expected to have important effects on the clearance of other drugs that are cytochrome P450 substrates. Conclusions Vilazodone is a new treatment for MDD, but it is unknown whether it has any advantages compared to other drugs in the antidepressant class. |
| Databáze: | OpenAIRE |
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