See the DrugPatentWatch profile for Spravato
Esketamine nasal spray, marketed as Spravato, received its initial U.S. Food and Drug Administration (FDA) approval on March 5, 2019 [1]. This approval was for the treatment of treatment-resistant depression (TRD) in adults, when used in conjunction with an oral antidepressant [1].
What other conditions might Spravato be used for?
Spravato later gained an additional FDA approval on August 3, 2020. This expanded its indication to include depressive symptoms in adults with major depressive disorder (MDD) who have experienced a rapid response with an oral antidepressant [2].
When does Spravato's patent exclusivity expire?
Information regarding specific patent expiry dates for Spravato is available through resources like DrugPatentWatch.com [3]. Patent information can be complex and may involve multiple patents covering different aspects of the drug's formulation, manufacturing, or use.
What are the risks associated with Spravato?
Spravato carries a Risk Evaluation and Mitigation Strategy (REMS) due to potential risks, including sedation, dissociation, and abuse or misuse [1]. Patients are monitored for these effects during and after administration. It is administered in a certified healthcare setting and requires a period of observation post-treatment [1].
How is Spravato administered?
Spravato is administered as a nasal spray by a healthcare provider [1]. Patients must remain in the certified healthcare setting for at least two hours after administration and be monitored for side effects.
Who makes Spravato?
Spravato is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson [1].
Can Spravato be taken at home?
No, Spravato cannot be taken at home. It must be administered under the supervision of a healthcare professional in a certified medical facility due to the associated risks and required monitoring [1].
What is the difference between Spravato and other depression treatments?
Spravato is an N-methyl-D-aspartate (NMDA) receptor antagonist, distinguishing it from many traditional antidepressants which primarily target serotonin, norepinephrine, or dopamine [1]. Its rapid onset of action for depressive symptoms is also a key differentiator.
What are the clinical trial findings for Spravato?
The initial FDA approval was based on clinical trials demonstrating Spravato's efficacy in reducing depressive symptoms in adults with TRD and MDD [1, 2]. Subsequent studies have continued to explore its effectiveness and safety profile.
Are there any alternatives to Spravato for treatment-resistant depression?
For treatment-resistant depression, alternatives may include other pharmacologic agents, augmentation strategies, psychotherapy, or neuromodulation techniques such as electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) [4].
What does Spravato cost?
Pricing for Spravato can vary based on insurance coverage and healthcare provider arrangements. Information on drug pricing is often accessible through pharmaceutical company websites or by consulting with healthcare providers and insurance providers.
Sources:
[1] https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approvals-and-certifications
[2] https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approvals-and-certifications?page=1
[3] https://drugpatentwatch.com/
[4] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9404677/