BEERSE - The Janssen Pharmaceutical Companies of
The application seeks to expand the use of esketamine nasal spray, beyond its current indication, as an acute short-term treatment, co-administered with oral antidepressant therapy, for the rapid reduction of depressive symptoms in adults with a moderate-to-severe depressive episode of major depressive disorder (MDD) who have current suicidal ideation with intent.
The submission is based on results from two double-blind, randomised, placebo-controlled multicentre Phase 3 clinical studies (ASPIRE I & II), which evaluated both the efficacy and safety of esketamine nasal spray versus a placebo nasal spray when used in addition to comprehensive standard of care (SOC). In these studies, SOC included initial hospitalisation and newly initiated and/or optimised antidepressant therapy, enhanced with extensive twice-weekly visits during the double-blind phase.1,2,3
In both ASPIRE I & II, esketamine nasal spray combined with comprehensive SOC was associated with a reduction in depressive symptoms, and demonstrated clinically meaningful and statistically significant superiority over a placebo nasal spray plus comprehensive SOC in rapidly reducing symptoms of MDD at 24 hours after the first dose.1,2,3 The benefit of esketamine nasal spray plus comprehensive SOC on symptoms of MDD was apparent as early as 4 hours after the first dose.1,2,3
'Janssen is committed to reducing the devastating burden caused by serious mental health disorders,' said
The safety profile was consistent with that observed in the clinical trial programme of esketamine in patients with treatment-resistant depression, with no new safety signals. In the clinical trials, the most common adverse events (20%) were dizziness, dissociation, nausea, somnolence and headache.1
'Patients with MDD who are assessed to be at imminent risk for suicide constitute a psychiatric emergency that require immediate intervention,' explains Professor
In ASPIRE I & II, both esketamine nasal spray plus comprehensive SOC and placebo nasal spray plus comprehensive SOC resulted in an improvement in severity of suicidality as measured by the revised Clinical Global Impression of Severity of Suicidality (CGI-SS-R) at 24 hours after the first dose. The treatment difference between the two groups on this secondary endpoint was not statistically significant. This may be due to the substantial beneficial effects of comprehensive SOC used in the clinical trial, including the impact of inpatient psychiatric hospitalisation in diffusing the acute suicidal crisis in subjects in both treatment groups.1,2,3
In
About SPRAVATO
As an antagonist of the N-methyl-D-aspartate (NMDA) glutamate receptor. SPRAVATO (esketamine) nasal spray offers the first new mechanism of action in 30 years to treat major depressive disorder (MDD).5,6
Esketamine nasal spray is self-administered through a single-use nasal spray device, offering a novel mode of drug administration for the treatment of MDD. The decision to prescribe esketamine nasal spray should be determined by a psychiatrist.7
Esketamine nasal spray was approved by the
Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at www.yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or
About Major Depressive Disorder
Major depressive disorder (MDD) affects nearly 40 million people of all ages in
About the Janssen Pharmaceutical Companies of
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of
Cautions Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding the product development of SPRAVATO. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of
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