SPRAVATO ®▼ (esketamine) nasal spray approved for reimbursement in Ireland for adults with treatment-resistant major depressive disorder

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that SPRAVATO®▼ (esketamine) nasal spray has been granted reimbursement in Ireland for the treatment of adults living with treatment-resistant major depressive disorder (TRD), in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI). People are considered to have TRD if they have not responded to at least two different treatments with antidepressants in the current moderate-to-severe depressive episode.1

Ireland has one of the highest rates of mental illness in Europe. It is estimated that approximately 150,000 people per year are living with severe depression. (Also known as Major Depressive Disorder or MDD) here.2,3 Major Depressive Disorder (MDD), the underlying disorder associated with Treatment Resistant Depression (TRD), is a severely debilitating psychiatric disorder.  For these patients, the main goal of treatment is to relieve the symptoms of depression. This is while ultimately achieving remission, with few, if any, symptoms of depression remaining.4 However, about one third of people with MDD do not respond to currently available treatments.5

Dr Lorcan Martin, Consultant Psychiatrist, St Loman’s Hospital, Mullingar, welcomed today’s news.

He commented, “Traditional treatments for depression have served us well for decades. But, unfortunately, a significant number of people do not respond to them. Having a new treatment modality offers hope to many for whom previous approaches have offered little by way of relief from symptoms.”

The approval of esketamine is based on data from a clinical trial programme in patients with TRD. This is including over 1,600 patients treated with esketamine. The five Phase 3 trials included three short-term studies. Then one randomised withdrawal and maintenance of effect study. Then finally, one long-term safety study.6,7,8,9,10* These data demonstrated that treatment with esketamine nasal spray plus a newly initiated oral antidepressant was associated with a greater reduction in depressive symptoms.

This is compared to a newly initiated oral antidepressant plus placebo nasal spray. It was in adult patients (18-64 years), with the onset of efficacy as early as Day 2.6 Approximately 70 percent of esketamine-treated patients responded to treatment, with a ≥50 percent symptom reduction. Furthermore, approximately half of all treated patients achieved remission at the end of the 4 week studies.1 Continued treatment with esketamine nasal spray plus oral antidepressant reduced the risk of relapse by 70 percent. This was among patients with stable response. 51 percent in patients in stable remission, compared to continuing treatment with oral antidepressant alone.9

Dr Thorsten Giesecke, General Manager, Commercial Business, Janssen Sciences Ireland UC

He said: “Building upon our strong heritage in helping to reduce the burden, disability and devastation caused by mental illness, Janssen is delighted that esketamine nasal spray is now available for Irish patients.  Major Depressive Disorder (MDD) can have a profound impact on someone’s ability to manage many areas of their life. We are proud this medicine is now available 30 years on from the last innovation and with this significant unmet need still remaining.”

The decision to prescribe esketamine should be determined by a psychiatrist.

Esketamine is intended to be self-administered by the patient under the direct supervision of a healthcare professional.1 A treatment session consists of nasal administration of esketamine and a post-administration observation period. Both administration and post -administration observation of esketamine should be carried out in the appropriate clinical setting.1

Across the five Phase 3 and one Phase 2 clinical trials, esketamine nasal spray demonstrated a favourable benefit-risk profile, with sustained efficacy and no new safety concerns were observed over a period of up to one year.6,7,8,9,10,11 The most commonly observed adverse events in TRD patients treated with esketamine were dizziness, nausea, dissociation, headache, somnolence, vertigo, dysgeusia, hypoaesthesia, and vomiting.1 These side effects were generally mild-to-moderate, transient (typically resolving within 2 hours) and occurred on the day of dosing.

Esketamine is an antagonist of the N-methyl-D-aspartate (NMDA) glutamate receptor and is understood to work differently than other currently available therapies for MDD.13,14 It is thought to help restore synaptic connections between brain cells in people with TRD, allowing for more activity and communication between specific regions of the brain.  Therefore based on results from clinical trials, this increase in activity and communication is thought to help improve the symptoms of depression.13,14

Further prescribing information can be found at https://www.medicines.ie/medicines/spravato-28-mg-nasal-spray-solution-35070/spc

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