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What injections can be given orally or via enteral feeding tubes?

6 November 2020This updated Medicines Q&A is a quick reference summary to different types of enteral feeding tubes, in relation to medication issues. Not all enteral feeding…

Safety in Lactation: Drugs used in status epilepticus

5 November 2020Choice of treatment will be influenced by the clinical situation. The evidence for these drugs in breastfeeding is based on their longer-term use rather than…

Safety in Lactation: Sedative and analgesic peri-operative drugs

25 September 2020Benzodiazepines are used for premedication and for conscious sedation during surgery. Following short–term therapy (1-2 doses) for these indications, it is considered that breastfeeding can…

Supply and/or administration of Controlled Drugs under a Patient Group Direction

8 September 2020This Q&A summarises the legal position on the supply and/or administration of controlled drugs under PGDs.
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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
17 September 2020

For premedication / conscious sedation

For premedication / conscious sedation
Yes
Lorazepam
Limited published evidence of safety
Small amounts in breast milk
Shorter acting benzodiazepine
17 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 19UCB have currently no plans to launch in the UK [6].
Nov 19Available in the US [5].
May 19UCB announced today that the FDA has approved a New Drug Application for NAYZILAM® (midazolam) nasal spray [4].
Aug 18FDA accepts filing [3].
Jun 18UCB 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 18PIII 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 18PIII 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].