Midazolam

Articles · Lactation Safety Information · New Medicines ·
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Articles

Lactation Safety Information

Buccal for status epilepticus

Buccal
for status epilepticus
Diazepam (rectal)
Limited published evidence of safety
Small amounts in breast milk
Short-term therapy (1-2 doses) considered not to pose a risk to the infant
17th September 2020

For premedication / conscious sedation

For premedication / conscious sedation
Lorazepam
Limited published evidence of safety
Small amounts in breast milk
Shorter acting benzodiazepine
17th September 2020

New Medicines

Nayzilam (US) · Epilepsy with increased seizure activity, e.g. seizure clusters, acute repetitive seizures - intranasal spray

Information

Nayzilam (US)
New formulation
UCB Pharma
UCB Pharma

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Launched
Nov 19 · UCB have currently no plans to launch in the UK [6].
Nov 19 · Available in the US [5].
May 19 · UCB announced today that the FDA has approved a New Drug Application for NAYZILAM® (midazolam) nasal spray [4].
Aug 18 · FDA accepts filing [3].
Jun 18 · UCB acquires rights for this product from Proximagen LLC [1].

Category

Benzodiazepine - GABA A agonist
The prevalence of active epilepsy is 5-10 cases per 1,000 - but with 5-30% of these misdiagnosed as having epilepsy [2].
Epilepsy with increased seizure activity, e.g. seizure clusters, acute repetitive seizures - intranasal spray
Intranasal

Trial or other data

Aug 18 · PIII ARTEMIS1 trial was reported in Apr 17 to have met its primary efficacy endpoint of termination of seizures within ten minutes of drug administration without any recurrence for up to six hours after the treatment [3].
Aug 18 · PIII clinical study (ARTEMIS 1 -Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray (NCT01390220)), which evaluated the safety and efficacy of midazolam nasal spray in 292 patients [1].