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Ready-to-use Epistatus® 10 mg Oromucosal Solution Midazolam – Marketing Authorisation granted

Posted in Neurology News on 28th Apr 2017


27th April 2017: Special Products Ltd has announced that Epistatus® 10 mg Oromucosal Solution, Midazolam, has been granted a UK Marketing Authorisation for use in the treatment of prolonged, acute convulsive seizures in children and adolescents aged 10 to less than 18 years, who have been diagnosed with epilepsy1. Buccal midazolam is recommended by NICE2 for the management of prolonged acute convulsive seizures, and is preferred by most patients and carers compared to the administration of rectal diazepam 3,4.

Epistatus is presented “ready-to-use” in a novel, pre-filled, single-dose syringe, to provide carers with the confidence that they are administering the correct dose1,5. The pre-filled syringe is contained within a specially-designed, secure and tamper-evident protective packaging.

In response to market research and insights, Special Products Ltd has invested heavily in the development of this new bespoke syringe, which is designed for administration into the buccal cavity5. The granting of this Marketing Authorisation represents an important milestone for Special Products Ltd, for whom Epistatus is their first licensed product.

The ready-to-use Epistatus pre-filled syringe will be available to prescribe from August 2017, further information to follow.