Dasotraline

Dasotraline is a serotonin norepinephrine dopamine reuptake inhibitor (SNDRI) that is under investigation for the treatment of attention deficit hyperactivity disorder (ADHD) and binge eating disorder (BED). It was developed by Sunovion, a pharmaceutical company specializing in the treatment of psychiatric and neurological conditions.

Pharmacology

Dasotraline is a potent and balanced reuptake inhibitor of serotonin, norepinephrine, and dopamine. It has a unique pharmacokinetic profile, with a long half-life of 47–77 hours, allowing for once-daily dosing. Dasotraline demonstrates a high degree of selectivity for monoamine transporters and does not affect post-synaptic receptors, ion channels, or enzymes.

Clinical Trials

Dasotraline has been investigated in several Phase II and III clinical trials for the treatment of ADHD and BED. In these trials, dasotraline demonstrated significant improvements in the symptoms of these disorders compared to placebo. However, the most common adverse events reported were insomnia, dry mouth, decreased appetite, anxiety, and nausea.

Regulatory Status

In August 2018, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Sunovion, indicating that they could not approve the New Drug Application (NDA) for dasotraline in its current form. The FDA requested additional data to further assess the efficacy and safety of dasotraline.

See Also

• Serotonin–norepinephrine–dopamine reuptake inhibitor
• Attention deficit hyperactivity disorder
• Binge eating disorder

Dasotraline Resources
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