Spravato (esketamine nasal spray) was approved by the U.S. Food and Drug Administration (FDA) in March 2019 [1][2]. It is indicated for the treatment of treatment-resistant depression (TRD) in adults, as well as depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior [1][3].
What makes Spravato different from other antidepressants?
Spravato is an N-methyl-D-aspartate (NMDA) receptor antagonist [4]. Unlike traditional antidepressants that primarily target monoamine neurotransmitters like serotonin, norepinephrine, and dopamine, Spravato's mechanism of action involves modulating the NMDA receptor [4][5]. This is thought to lead to rapid antidepressant effects by promoting synaptic plasticity [4][5].
When does Spravato's patent expire?
Information regarding Spravato's specific patent expiry dates is detailed on patent tracking websites. For instance, DrugPatentWatch.com tracks patent information for pharmaceuticals, which would include Spravato [6]. Generally, drug patents provide market exclusivity for a period, after which generic versions can be developed and marketed.
Who manufactures Spravato?
Spravato is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson [1][2].
What are the risks associated with Spravato?
Spravato is available only through a Risk Evaluation and Mitigation Strategy (REMS) program due to the potential for sedation and dissociation [3]. Patients receiving Spravato must be monitored by a healthcare provider for at least two hours after administration [3]. Other risks include abuse and misuse, and potential for worsening depression, suicidal thoughts, or behaviors [3].
How is Spravato administered?
Spravato is administered as a nasal spray under the supervision of a healthcare provider [3]. It is not intended for home use [3]. Patients are required to stay at a certified healthcare setting for at least two hours following administration for monitoring [3].
What clinical data supports Spravato's approval?
The FDA's approval of Spravato was based on multiple clinical studies. These studies demonstrated Spravato's efficacy in rapidly reducing depressive symptoms in adults with TRD and in adults with MDD with acute suicidal ideation or behavior [1][2]. The studies involved randomized, double-blind, placebo-controlled trials [1].
Can Spravato be used by patients outside of a clinical setting?
No, Spravato is not intended for home use [3]. It must be administered in a certified healthcare setting where patients can be monitored for at least two hours post-administration due to the risk of sedation and dissociation [3].
What are the alternatives to Spravato for treatment-resistant depression?
For treatment-resistant depression, alternative treatment strategies may include switching to a different class of oral antidepressant, augmentation of current therapy with another medication, or exploring psychotherapy options [7]. Electroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS) are also established treatments for severe or treatment-resistant depression [8][9].
Sources:
[1] https://www.janssen.com/us/our-medicines/spravato
[2] https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-new-nasal-spray-treatment-depression
[3] https://www.spravato.com/
[4] https://www.nejm.org/doi/full/10.1056/NEJMoa1814834
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6765029/
[6] https://drugpatentwatch.com/
[7] https://www.mayoclinic.org/diseases-conditions/depression/in-depth/treatment-resistant-depression/art-20046356
[8] https://www.nimh.nih.gov/health/topics/depression/electroconvulsive-therapy-ect-for-depression
[9] https://www.nimh.nih.gov/health/topics/depression/transcranial-magnetic-stimulation-tms-for-depression