SPRAVATO™ Nasal Spray (esketamine) Licensed in EU for treatment-resistant MDD

Esketamine is used as a fast-acting nasal spray treating patients who have not reacted well to conventional antidepressants.

It is used to treat severe depression and is already being marketed in the US under the brand name SPRAVATO™ by leading pharma producer Janssen Pharmaceutical Companies of Johnson & Johnson.

SPRAVATO™ (esketamine) approval

Janssen confirmed the drug had been authorised by the European Commission. The National Institute for Health and Care Quality (NICE) is expected to rule on the use of the drug in the United Kingdom by June next year.

The EC approval is valid for all 28 member states in the EU, as well as the EEA members (Norway, Iceland and Liechtenstein.

SPRAVATO™ innovation

Therapy with Esketamine nasal spray in conjunction with a newly instigated oral antidepressant was associated with a significant reduction in depressive symptoms, with around half of all patients achieving recovery after four weeks of effective therapy from the second day of administration.

SPRAVATO® (esketamine) nasal spray, as an antagonist of the N-methyl-D-aspartate (NMDA) glutamate receptor, offers the first new mechanism of action in around three decades to treat Major Depressive Disorder (MDD).

Major Depressive Disorder (MDD)

Patients are considered to have treatment-resistant Major Depressive Disorder (MDD) if they did not react to at least two alternative treatments with Antidepressants. Approximately a third of those patients do not respond to the conventional antidepressant therapy.  

Major Depressive Disorder affects around 40 million people in Europe and is the world’s leading cause of disability.

“MDD is a debilitating illness that can have a profound impact on patients and their loved ones”, said the President of the International College of Neuropsychopharmacology (CINP), Professor Siegfried Kasper for Bloomberg.

The main goal in therapy for these patients is to reduce depression symptoms and finally achieve relief.

For these patients, the European Commission approved SPRAVATO™ Excetamene nasal spray in combination with Oral Serotonin or Serotonin Norepinephrine inhibitor. 

Esketamine nasal spray displayed a favourable benefit-risk profile with sustained effectiveness and no new safety issues were reported for up to one year.

Approximately 70 percent of patients treated with Esketamine responded with a reduction in symptoms of about 50 percent. In addition, at the conclusion of the 4-week trials, about half of all treated patients reached remission.


Bloomberg: SPRAVATO®▼ (Esketamine) Nasal Spray Approved in Europe for Adults with Treatment-Resistant Major Depressive Disorder

Janssen: Janssen Announces U.S. FDA Approval of SPRAVATO™ (esketamine) CIII Nasal Spray for Adults with Treatment-Resistant Depression (TRD) Who Have Cycled Through Multiple Treatments Without Relief

 /Business Wire/ BEERSE, Belgium -- December 19, 2019 - SPRAVATO®▼ (Esketamine) Nasal Spray Approved in Europe for Adults with Treatment-Resistant Major Depressive Disorder