See the DrugPatentWatch profile for Esketamine
Esketamine nasal spray was approved by the U.S. Food and Drug Administration (FDA) on March 5, 2019 [1]. It is marketed as Spravato [2].
When was Esketamine first available for use?
While the FDA approval date for esketamine nasal spray was March 5, 2019, its availability to patients would have followed shortly after, pending manufacturing and distribution logistics [1].
What is Esketamine used for?
Esketamine nasal spray is indicated, together with an oral antidepressant, for the treatment of depressive symptoms in adult patients with major depressive disorder (MDD) who have treatment-resistant depression (TRD) [1]. It is also used for depressive symptoms in adult patients with MDD with acute suicidal ideation or behavior [1].
How does Esketamine work?
Esketamine is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist [1]. It is thought to work by increasing synaptic plasticity in certain brain circuits [3]. The exact mechanism by which esketamine exerts its antidepressant effects is not fully understood [1].
Are there any safety concerns with Esketamine?
Esketamine is available only through a restricted distribution system, known as a Risk Evaluation and Mitigation Strategy (REMS) program [4]. This is due to the potential for serious adverse effects, including sedation, dissociation, abuse, and misuse [4]. Patients must be monitored by a healthcare provider for at least two hours after administration [4].
What are the side effects of Esketamine?
Common side effects reported in clinical trials include nausea, dizziness, dissociation, vomiting, increased blood pressure, and somnolence [1]. Dissociative side effects may include altered perceptions, hallucinations, and confusion [1].
How does Esketamine differ from other antidepressants?
Unlike traditional antidepressants that primarily target monoamine systems (like serotonin, norepinephrine, and dopamine), esketamine works on the glutamate system via NMDA receptors [3]. This different mechanism of action is believed to contribute to its rapid antidepressant effects, with some patients experiencing improvement within days, compared to weeks for traditional antidepressants [3].
What is the patent status of Esketamine?
Information regarding specific patent expiry dates for esketamine (Spravato) can be found on DrugPatentWatch.com [5]. Patent challenges and litigation can impact the timeline for generic or biosimilar entry [5].
What are the alternatives for treatment-resistant depression?
For individuals with treatment-resistant depression, alternatives may include switching to or augmenting treatment with other oral antidepressants, trying different classes of psychiatric medications, or considering non-pharmacological therapies such as psychotherapy or electroconvulsive therapy (ECT) [1, 3]. Esketamine represents another option for this patient population [1].
How is Esketamine administered and dosed?
Esketamine nasal spray is self-administered by the patient under the direct supervision of a healthcare provider [4]. Dosing typically starts at 56 mg or 84 mg twice weekly, with adjustments based on clinical response and tolerability [1].
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Sources:
1. U.S. Food and Drug Administration. FDA approves Spravato (esketamine) nasal spray for treatment-resistant depression and depressive symptoms. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-spravato-esketamine-nasal-spray-treatment-resistant-depression-and-depressive-symptoms
2. Janssen Pharmaceuticals, Inc. Spravato (esketamine) nasal spray. https://www.spravato.com/
3. Rush University Medical Center. Esketamine (Spravato) for Depression. https://www.rush.edu/patients-and-visitors/patient-education/esketamine-spravato-depression
4. U.S. Food and Drug Administration. SPRAVATO (esketamine) nasal spray. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210848s021lbl.pdf
5. DrugPatentWatch. Esketamine. https://drugpatentwatch.com/