Public Summary SwissPAR – Spravato® (esketamine)

Public Summary SwissPAR dated 23.06.2020

Spravato® (active substance: esketamine)

First authorisation in Switzerland: 25.02.2020

Medicine for the treatment of adults with treatment-resistant depression

About the medicine

Spravato is a nasal spray containing the active ingredient esketamine. It was authorised in Switzerland on 25 February 2020 for the management of treatment-resistant depression in adults who have not responded to at least two different treatments with antidepressants for the current moderate to severe depressive episode.

Spravato is used in combination with another, oral, antidepressant.

Mode of action

Depression can develop when the nerve cells (synapses) in the brain that regulate mood and emotional behaviour are impaired. This can be caused by a wide variety of factors. Esketamine, the active substance in Spravato, is an antidepressant. It acts on the nerve cells in the brain and regulates the transmission of signals between cells that are involved in the regulation of mood.

As a result, Spravato helps improve the symptoms of depression.

Use

Spravato is a nasal spray and may be prescribed only by a psychiatrist. Spravato must be taken together with another, oral, antidepressant. Spravato may be administered only in a setting (hospital, clinic, medical practice) with the equipment and facilities for resuscitation and with healthcare professionals who are trained in cardiopulmonary resuscitation and who are able to perform active ventilation and manage blood pressure crises.

Blood pressure must be measured before and after using Spravato. If the blood pressure is too high before the start of the treatment, the doctor must assess the situation and decide whether the treatment should be administered.

Spravato nasal spray is intended for self-administration by the patient under the supervision of the doctor.

Due to the possibility of sedation (severe depression of the central nervous system), dissociation and elevated blood pressure, patients must be monitored for at least two hours under the supervision of a doctor until their condition is considered stable enough for them to be discharged.

Since nausea and vomiting can occur after the administration of Spravato, the patient should not eat for two hours, or drink for 30 minutes, prior to administration.

The starting dose is one or two sprays in each nostril (depending on the patient's age) on the first day. This is followed by 1, 2 or 3 sprays in each nostril twice a week for 4 weeks. If the doctor believes that the treatment should be continued, Spravato should be administered once a week after 5 weeks. If necessary, Spravato should be administered once every 1 or 2 weeks from the 9th week.

Efficacy

The efficacy and safety of Spravato have been investigated in five different studies with over 1,800 patients. One group of patients received Spravato twice a week in addition to an oral antidepressant. The other group received a dummy drug (placebo) in addition to an oral antidepressant.

The efficacy of Spravato was determined by means of a questionnaire (Montgomery-Asberg Depression Rating Scale, MADRS). This questionnaire is a known instrument for assessing the severity of depression. The questionnaire was completed by independent third parties. The key criterion for assessing the efficacy of Spravato was the change in the score obtained for the study participants after 28 days of treatment with Spravato or the dummy drug.

The results showed that Spravato is more effective than a dummy drug. The health of the patients treated with Spravato improved noticeably compared to the health of those patients who received the dummy drug.

Other studies have proved that patients treated with Spravato suffer fewer relapses than those who receive a dummy drug. They have also shown that the effect of Spravato is maintained in the long term.

Precautions, undesirable effects & risks

Spravato may not be used:

  • in those who are hypersensitive to the active substance or any of the excipients,
  • ­if an increase in blood pressure or pressure in the brain (intracranial pressure) poses a serious risk to health,
  • ­in those with vascular disorders or weaknesses in blood vessel walls,
  • ­in patients who have had bleeding in the brain,
  • ­in patients who have recently suffered a heart attack.

The active substance poses a risk of dependence on Spravato and of possible misuse.

Experience has shown that the risk of suicide may increase at the start of an antidepressant treatment.

The most common adverse effects (in more than 10% of all patients treated with Spravato) were nausea, dissociation (the feeling of being disconnected from one's physical surroundings and emotions), dizziness, headache, taste disturbances, sleepiness, reduced sense of touch, abnormal skin sensations (tingling, pins and needles, furry feeling, numbness, prickling, itching and similar), feeling of numbness in the mouth and elevated blood pressure.

Due to the possibility of sedation (severe depression of the central nervous system), dissociation and elevated blood pressure, patients must be monitored for at least two hours under the supervision of a doctor until their condition is considered to be stable enough for them to be discharged.

All precautions, risks and other possible undesirable effects are listed in the Information for healthcare professionals.

Why the medicine has been authorised

Treatment-resistant depression is highly stressful for patients. Studies have shown that, when administered in addition to an oral antidepressant, the medicinal product Spravato containing the active ingredient esketamine alleviates the depressive symptoms in patients who have failed to respond to other treatments. Their general mental health was improved in both the short and long term.

Since there is a risk that patients may misuse – or become dependent on – this medicine, its prescription and dispensing must be well monitored and documented. The administration of Spravato must also be supervised and monitored by a doctor.

Taking all the precautions into account, and based on the available data, the benefits of Spravato outweigh the risks described above. Swissmedic has therefore authorised the medicine Spravato with the active substance esketamine for use in Switzerland.

Further information on the medicinal product

Information for healthcare professionals:

Healthcare professionals (doctors, pharmacists and others) can answer any further questions.

 

This information is correct as at the date above. New information concerning the authorised medicinal product in question will not be incorporated into the Public Summary SwissPAR.

Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals.

New findings that could impair the quality, efficacy or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.

Swissmedic currently recognises the following as countries with comparable medicinal product control:

  • Australia
  • EU, EEA and EFTA Member States
  • Japan
  • Canada
  • New Zealand
  • Singapore
  • USA

Last modification 23.06.2020

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