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The brand name for the ketamine nasal spray used for treatment-resistant depression is Spravato [1].
What is Spravato used for?
Spravato is an esketamine nasal spray indicated, along with an oral antidepressant, for the treatment of adults with treatment-resistant depression (TRD). It is also used for depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior [2].
How does Spravato work?
Spravato is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. By blocking these receptors, it is thought to increase glutamate activity in the brain, which may help to rapidly alleviate depressive symptoms [2].
What is the difference between ketamine and esketamine?
Ketamine is a racemic mixture containing two enantiomers: esketamine and arketamine. Spravato contains esketamine, one of these enantiomers [1].
How is Spravato administered?
Spravato is administered as a nasal spray under the supervision of a healthcare provider in a certified medical office or clinic. It is not for at-home use [2]. Patients must be monitored for at least two hours after administration [3].
When does patent protection for Spravato expire?
The patent expiration dates for Spravato are complex and involve multiple patents, some of which are still active. DrugPatentWatch.com tracks these patents and their expiration timelines [4].
Who makes Spravato?
Spravato is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson [1].
What are the risks associated with Spravato?
Spravato carries a risk of serious side effects, including [2, 3]:
* Sedation and dissociation
* Abuse and misuse
* Increased blood pressure
* Bladder issues
* Potential for fetal harm
Due to these risks, Spravato is available only through a restricted distribution program called the Spravato REMS (Risk Evaluation and Mitigation Strategy) [3].
What clinical data supports Spravato's efficacy?
Clinical trials have demonstrated that Spravato, when used in conjunction with an oral antidepressant, led to a statistically significant reduction in depressive symptoms compared to placebo in patients with TRD [2].
What are the alternatives to Spravato for treatment-resistant depression?
Besides Spravato, other treatment options for treatment-resistant depression may include different oral antidepressants, augmentation strategies with existing medications, electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), and off-label use of intravenous ketamine infusions [5].
What is the cost of Spravato?
The cost of Spravato can vary depending on insurance coverage and the treatment setting. Patients should consult with their healthcare provider and insurance provider for specific cost information [6].
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Sources:
[1] https://www.drugpatentwatch.com/
[2] https://www.spravato.com/
[3] https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210928s026lbl.pdf
[4] https://drugpatentwatch.com/p/spravato-esketamine-nasal-spray/patents
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6886622/
[6] https://www.goodrx.com/spravato