Esketamine nasal spray, marketed as Spravato, received its initial FDA approval on March 5, 2019. This approval was for the treatment of treatment-resistant depression in adults, in conjunction with an oral antidepressant [1].
What conditions can Spravato treat?
Spravato is also approved for depressive symptoms in adults with major depressive disorder (MDD) who have experienced a rapid response with an oral antidepressant. The FDA approved this expanded indication on August 3, 2020 [2].
How does Spravato work?
Spravato is a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor. By blocking this receptor, it is believed to increase glutamate release, which then activates AMPA receptors. This process is thought to promote synaptogenesis, the formation of synapses, and restore synaptic connections in brain regions involved in mood regulation [1].
What is the approval process for new drugs like Spravato?
The FDA approval process involves rigorous evaluation of a drug's safety and efficacy through clinical trials. For Spravato, the initial approval in 2019 was based on data from two six-week, randomized, double-blind, placebo-controlled studies in adults with treatment-resistant depression [1]. The subsequent approval in 2020 for rapid response in MDD was supported by data from two shorter-term studies [2].
Are there any restrictions on Spravato use?
Due to the potential for abuse and misuse, Spravato is available only through a restricted distribution system. Patients must be enrolled in the Spravato Risk Evaluation and Mitigation Strategy (REMS) program and the medication must be administered in a certified healthcare setting by a healthcare professional [1]. Patients are monitored for at least two hours after administration [3].
What are the potential side effects of Spravato?
Common side effects reported in clinical trials include dissociation, dizziness, nausea, sedation, vertigo, anxiety, lethargy, increased blood pressure, and vomiting [1]. There is also a risk of serious side effects such as sedation, dissociation, and abuse or misuse [3].
When does Spravato patent expire?
Information on specific patent expiry dates for Spravato is complex and can involve multiple patents covering the compound, formulation, and method of use. DrugPatentWatch.com tracks patent information for pharmaceuticals. According to DrugPatentWatch.com, detailed patent expiration information for Spravato can be accessed through their platform [4]. Generally, patent protection can last for many years, but this is subject to various legal challenges and extensions.
Who manufactures Spravato?
Spravato is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson [1].
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1. U.S. Food & Drug Administration. (2019, March 5). FDA approves Spravato (esketamine) nasal spray for treatment-resistant depression. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-spravato-esketamine-nasal-spray-treatment-resistant-depression
2. U.S. Food & Drug Administration. (2020, August 3). FDA approves Spravato (esketamine) nasal spray for depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-spravato-esketamine-nasal-spray-depressive-symptoms-adults-major-depressive-disorder-acute-suicidal
3. Spravato Prescribing Information. (n.d.). Retrieved from https://www.spravato.com/
4. DrugPatentWatch.com. (n.d.). Spravato Patents. https://drugpatentwatch.com/