Expand all sections

Esketamine

Keyzilen

Extended indication Tinnitus
Therapeutic value Possible added value
Registration phase Clinical trials

Product

Active substance Esketamine
Domain Neurological disorders
Main indication Neurological disorders other
Extended indication Tinnitus
Proprietary name Keyzilen
Manufacturer Auris
Route of administration Auricular
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks NMDA receptor antagonist ook gebruikt bij anaesthesie, depressie (en als partydrug).

Registration

Registration route Centralised (EMA)
Particularity New therapeutical formulation
Orphan drug No
Registration phase Clinical trials
Additional remarks Registatieproces: 'Fast Track Designation' in Amerika (FDA).

Therapeutic value

Current treatment options Geen andere behandelopties.
Therapeutic value Possible added value
Substantiation http://www.renalandurologynews.com/drugs-in-the-pipeline/fda-fast-tracks-esketamine-gel-for-acute-inner-ear-tinnitus/article/510189/
Frequency of administration 3 times every 4 days
Dosage per administration 0.87 mg/ml
References http://adisinsight.springer.com/drugs/800023242; https://www.sps.nhs.uk/medicines/esketamine/
Additional remarks Toedieningsfrequentie betreft 3x over 3-5 dagen.

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Additional remarks Verwachting is dat het meerkosten gaat opleveren. Bij ontbreken andere opties zal er waarschijnlijk een hoge prijs gevraagd worden, vraag is hoe snel me-too preperaten beschikbaar komen omdat de basisstof niet vernieuwend is.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use No

Indication extension

Indication extension No

Other information

There is currently no futher information available.