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Spravato

17 March 2021

The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).

More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.

Australian prescription medicine decision summary

Summary of submission

Submission type
New chemical entity
Product name

Spravato

Active ingredients
Esketamine hydrochloride
ATC codes
N06AX27
Decision
Approved
Date of decision
5 March 2021
Date of entry onto ARTG
9 March 2021
Original publication date
17 March 2021
ARTG numbers
311827
Black Triangle Scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia.
Sponsor
Janssen-Cilag Pty Ltd
Sponsor address
1-5 Khartoum Road, Macquarie Park NSW 2113
Dose forms
Nasal spray solution
Strength
32.3 mg esketamine hydrochloride (equivalent to 28 mg of esketamine) per 2 actuations
Other ingredients
Citric acid monohydrate, disodium edetate, sodium hydroxide, water for injections
Containers
Vial assembled in nasal spray device
Pack sizes
1, 2 or 3 single-use nasal spray devices
Routes of administration
Nasal
Dosage

Spravato should be administered in conjunction with a newly initiated oral antidepressant (AD). During the Phase III clinical program patients were assigned a serotonin and norepinephrine reuptake inhibitor (SNRI) or selective serotonin reuptake inhibitor (SSRI) as the new oral antidepressant (see Section 5.1 Pharmacodynamic properties, clinical trials, in the Product Information).

Spravato will be provided by the supervising healthcare professional for the patient to self-administer under their direct supervision. A treatment session consists of nasal administration of Spravato and post administration observation under the supervision of a healthcare professional (see Section 4.4 Special warnings and precautions for use, in the Product Information).

Dosage - adults

The dosage recommendations for Spravato are shown in Table 1 of the Product Information. Recommended dosing consists of an induction phase (Weeks 1 to 4), followed by a maintenance phase (Week 5 onwards). Dose adjustments should be made based on efficacy and tolerability to the previous dose.

For further information refer to the Product Information.

Pregnancy category

B3

Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.

Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.

What was approved?

Spravato (esketamine hydrochloride) was approved for the following therapeutic use:

Spravato is indicated for treatment resistant depression (Major Depressive Disorder in adults who have not responded adequately to at least two different antidepressants of adequate dose and duration to treat the current moderate to severe depressive episode).

Spravato is to be initiated in conjunction with a newly initiated oral antidepressant.

What is this medicine and how does it work?

What was the decision based on?

What steps were involved in the decision process?

What post-market commitments will the sponsor undertake?

  • Spravato (esketamine hydrochloride) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Spravato must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
  • The Spravato European Union (EU)-risk management plan (RMP) (version 1.0 Succession 2, date 20 May 2019; data lock point 4 March 2018), with Australian specific Annex (version 0.2; date 27 June 2019), included with submission PM-2018-04814-1-1, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.

    An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).

    Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.

    If the product is approved in the EU during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at: ARTG search.

Australian Public Assessment Reports (AusPARs) can be found at: AusPAR search.

The latest news and updates regarding therapeutic goods regulation can be found at: TGA news room.