Dasotraline: Difference between revisions

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'''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.
{{Short description|Overview of the drug Dasotraline}}
{{Drugbox
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| image_alt = Chemical structure of Dasotraline
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'''Dasotraline''' is a [[medication]] that was under development for the treatment of [[attention deficit hyperactivity disorder]] (ADHD) and [[binge eating disorder]]. It is a [[dopamine]] and [[norepinephrine reuptake inhibitor]] (DNRI), which means it works by increasing the levels of these neurotransmitters in the brain.


==Pharmacology==
==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.
Dasotraline is classified as a [[dopamine reuptake inhibitor]] and a [[norepinephrine reuptake inhibitor]]. It has a long half-life, which allows for once-daily dosing. The drug's mechanism of action involves blocking the reuptake of dopamine and norepinephrine, thereby increasing their availability in the [[synaptic cleft]]. This action is thought to contribute to its therapeutic effects in ADHD and binge eating disorder.
 
==Development==
Dasotraline was developed by [[Sunovion Pharmaceuticals]]. It was investigated in clinical trials for the treatment of ADHD and binge eating disorder. However, as of the latest updates, the development of dasotraline for these indications has faced challenges, and its approval status remains uncertain.


==Clinical Trials==
==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.
Clinical trials for dasotraline have shown mixed results. In studies for ADHD, dasotraline demonstrated efficacy in reducing symptoms compared to placebo. However, concerns about side effects and the overall benefit-risk profile have been raised. In trials for binge eating disorder, dasotraline showed promise in reducing binge eating episodes.
 
==Side Effects==
Common side effects of dasotraline include insomnia, decreased appetite, and dry mouth. Some patients may experience increased heart rate and blood pressure. As with other medications affecting neurotransmitter levels, there is a potential for more serious side effects, which necessitates careful monitoring by healthcare providers.


==Regulatory Status==
==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.
The regulatory status of dasotraline has been complex. While it has shown potential in clinical trials, regulatory agencies have requested additional data to better understand its safety and efficacy profile. As a result, its approval for clinical use has been delayed.


==See Also==
==Related pages==
* [[Serotonin–norepinephrine–dopamine reuptake inhibitor]]
* [[Attention deficit hyperactivity disorder]]
* [[Attention deficit hyperactivity disorder]]
* [[Binge eating disorder]]
* [[Binge eating disorder]]
* [[Dopamine reuptake inhibitor]]
* [[Norepinephrine reuptake inhibitor]]


[[Category:Drugs]]
[[Category:Drugs]]
[[Category:Pharmacology]]
[[Category:Dopamine reuptake inhibitors]]
[[Category:Psychiatry]]
[[Category:Norepinephrine reuptake inhibitors]]
[[Category:Neurology]]
 
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Revision as of 04:06, 13 February 2025

Overview of the drug Dasotraline


Dasotraline
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Dasotraline is a medication that was under development for the treatment of attention deficit hyperactivity disorder (ADHD) and binge eating disorder. It is a dopamine and norepinephrine reuptake inhibitor (DNRI), which means it works by increasing the levels of these neurotransmitters in the brain.

Pharmacology

Dasotraline is classified as a dopamine reuptake inhibitor and a norepinephrine reuptake inhibitor. It has a long half-life, which allows for once-daily dosing. The drug's mechanism of action involves blocking the reuptake of dopamine and norepinephrine, thereby increasing their availability in the synaptic cleft. This action is thought to contribute to its therapeutic effects in ADHD and binge eating disorder.

Development

Dasotraline was developed by Sunovion Pharmaceuticals. It was investigated in clinical trials for the treatment of ADHD and binge eating disorder. However, as of the latest updates, the development of dasotraline for these indications has faced challenges, and its approval status remains uncertain.

Clinical Trials

Clinical trials for dasotraline have shown mixed results. In studies for ADHD, dasotraline demonstrated efficacy in reducing symptoms compared to placebo. However, concerns about side effects and the overall benefit-risk profile have been raised. In trials for binge eating disorder, dasotraline showed promise in reducing binge eating episodes.

Side Effects

Common side effects of dasotraline include insomnia, decreased appetite, and dry mouth. Some patients may experience increased heart rate and blood pressure. As with other medications affecting neurotransmitter levels, there is a potential for more serious side effects, which necessitates careful monitoring by healthcare providers.

Regulatory Status

The regulatory status of dasotraline has been complex. While it has shown potential in clinical trials, regulatory agencies have requested additional data to better understand its safety and efficacy profile. As a result, its approval for clinical use has been delayed.

Related pages