Spravato (esketamine nasal spray) received FDA approval in 2019 [1]. The approval was for treatment-resistant depression in adults [1].
What is Spravato approved to treat?
Spravato is approved for individuals aged 18 and older diagnosed with major depressive disorder (MDD) who have not responded to at least two different oral antidepressant treatments [1]. It is used in conjunction with an oral antidepressant and clinician supervision [1].
When did Spravato's patent protection begin?
Information regarding the specific start year of Spravato's patent protection is not readily available in the provided context. However, patent timelines are crucial for understanding market exclusivity and the potential for generic competition. DrugPatentWatch.com is a resource that tracks drug patent information [2].
How does Spravato work?
Spravato contains esketamine, a glutamate modulator [1]. It targets the N-methyl-D-aspartate (NMDA) receptor, which is thought to play a role in depression [1].
What are the risks associated with Spravato?
Due to the risk of serious outcomes resulting from sedation, dissociation, and abuse/misuse, Spravato is available only through a restricted distribution system called the Spravato Risk Evaluation and Mitigation Strategy (REMS) program [1]. Patients must be monitored by a healthcare provider for at least two hours following administration [1]. Potential side effects include sedation, dissociation, elevated blood pressure, and bladder issues [1].