See the DrugPatentWatch profile for Spravato
Spravato, also known by its generic name esketamine, is a nasal spray medication used for treatment-resistant depression and depressive symptoms in adults with major depressive disorder [1]. Its National Drug Code (NDC) is a unique identifier used in the United States to track prescription drugs.
What is the NDC for Spravato?
The NDC for Spravato is structured to identify the manufacturer, drug product, and package size. For Spravato, common NDC prefixes are associated with its manufacturer, Janssen Pharmaceuticals. Specific NDC numbers vary based on the dosage and packaging. For example, Spravato is available in 56.5 mg/actuator and 84.2 mg/actuator strengths [2].
How does Spravato work?
Spravato is a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor [3]. Esketamine is thought to rapidly increase synaptic plasticity by modulating the NMDA receptor, which may help to alleviate depressive symptoms [4].
When did Spravato receive FDA approval?
The U.S. Food and Drug Administration (FDA) approved Spravato for use in treatment-resistant depression in adults on March 5, 2019 [1]. It was later approved for depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior on August 1, 2020 [5].
What are the risks associated with Spravato?
Spravato carries a risk of serious side effects, including sedation, dissociation, and abuse and misuse. It is only available through a restricted distribution system called the Spravato Risk Evaluation and Mitigation Strategy (REMS) program [1]. Patients taking Spravato require monitoring for at least two hours after administration due to the risk of sedation and dissociation [6].
How is Spravato administered?
Spravato is administered as a nasal spray in a healthcare setting under the supervision of a healthcare provider [1]. Patients must not drive or operate heavy machinery for at least two hours after administration due to the risk of sedation and dissociation [6].
Are there any alternatives to Spravato for treatment-resistant depression?
Other treatment options for treatment-resistant depression may include augmentation of existing antidepressant medications with other drugs, switching to a different antidepressant class, or psychotherapy [7]. Other medications that modulate neurotransmitters, such as those affecting serotonin, norepinephrine, or dopamine, are also used [7].
What is the patent status for Spravato?
Information on drug patents, including for Spravato, can be tracked through resources like DrugPatentWatch.com. Patents for Spravato, including its formulation and method of use, may affect its market exclusivity and the potential for generic or biosimilar competition [8].
Sources:
[1] https://www.spravato.com/
[2] https://www.goodrx.com/spravato
[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6571201/
[4] https://www.nejm.org/doi/full/10.1056/NEJMoa1814758
[5] https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-esketamine-nasal-spray-treatment-depressive-symptoms-adults-major-depressive-disorder
[6] https://www.janssen.com/spravato-risk-evaluation-and-mitigation-strategy-rems
[7] https://www.mayoclinic.org/diseases-conditions/depression/in-depth/treatment-resistant-depression/art-20049706
[8] https://drugpatentwatch.com/