Bifeprunox
Bifeprunox is a novel atypical antipsychotic agent that was under development for the treatment of schizophrenia, bipolar disorder, and major depressive disorder. It was developed by the Belgian pharmaceutical company Solvay Pharmaceuticals, and later licensed to Wyeth Pharmaceuticals in the United States. However, the development of Bifeprunox was discontinued in 2009 due to regulatory concerns.
Pharmacology[edit | edit source]
Bifeprunox has a unique mechanism of action compared to other atypical antipsychotics. It acts as a partial agonist at the dopamine D2 and D3 receptors, and at the serotonin 5-HT1A receptors. This means that it can both stimulate and inhibit these receptors, depending on the circumstances. This is in contrast to most other atypical antipsychotics, which are full antagonists at the dopamine receptors.
Clinical Trials[edit | edit source]
Bifeprunox underwent several clinical trials to evaluate its efficacy and safety in patients with schizophrenia and bipolar disorder. In these trials, Bifeprunox demonstrated efficacy in reducing the symptoms of schizophrenia, but its effects on bipolar disorder were less clear. The most common side effects reported were nausea, vomiting, and insomnia.
Regulatory Status[edit | edit source]
In 2007, the U.S. Food and Drug Administration (FDA) issued a non-approval letter for Bifeprunox, citing concerns about its safety and efficacy. The FDA requested additional data from clinical trials, which Solvay and Wyeth were unable to provide. As a result, the development of Bifeprunox was discontinued in 2009.
See Also[edit | edit source]
- Atypical antipsychotic
- Schizophrenia
- Bipolar disorder
- Major depressive disorder
- Solvay Pharmaceuticals
- Wyeth Pharmaceuticals
- Clinical trials
- U.S. Food and Drug Administration
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