Spravato

esketamine

Table of contents

Opinion

On 17 October 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Spravato, intended for combination treatment in adults with treatment-resistant major depressive disorder. The applicant for this medicinal product is Janssen-Cilag International N.V.

Spravato will be available as a 28 mg nasal spray solution. The active substance of Spravato is esketamine, a Psychoanaleptic, Other antidepressants (ATC code: N06AX27). The antidepressant effect of esketamine is mediated via its antagonist activity on N-methyl-D-aspartate receptor (NMDAR) which produces a transient increase in glutamate release.

The benefits with Spravato are its ability to reduce a broad range of depressive symptoms in patients with a moderate to severe depressive episode that has not responded to at least two different treatments with antidepressants. The most common side effect are dizziness, nausea, dissociation, headache, somnolence and vertigo.

The full indication is: “Spravato, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant major depressive disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode”. Treatment with Spravato should be initiated by psychiatrists to ensure a correct diagnosis of treatment-resistant major depressive disorder.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Key facts

Name
Spravato
Agency product number
EMEA/H/C/004535
International non-proprietary name (INN) or common name
  • esketamine
Active substance
  • esketamine hydrochloride
Therapeutic area
Depressive Disorder
Date opinion adopted
17/10/2019
Company name
Janssen-Cilag International N.V.
Status
Positive
Application type
Initial authorisation

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