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Safety in Lactation: Control of epilepsy

21 September 2020Choice will depend on clinical condition, and should primarily be based on suitability for the patient, rather than safety during breastfeeding. Whilst sodium valproate  is…
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Lactation Safety Information

Suitable alternative antiepileptic
No published evidence of safety
Very long half-life increases the risk of accumulation in breastfed infants
22 September 2020

New Medicines

FycompaPartial onset seizures (POS) or primary generalised tonic clonic seizures in children aged 4 to 12 years - oral suspension formulation

Information

Fycompa
Licence extension / variation
Eisai
Eisai

Development and Regulatory status

Launched
Launched
Launched
November 2020
Nov 20Licence extension approved in EU [11].
Sep 20Recommended for EU approval by CHMP - the additional indication includes "for the adjunctive treatment of: partial-onset seizures (POS) with or without secondarily generalised seizures in patients from 4 years of age and older; primary generalised tonic-clonic (PGTC) seizures in patients from 7 years of age and older with idiopathic generalised epilepsy (IGE)" [10].
Feb 19Filed in EU [8].
Sep 18Launched in US [7].
May 18EU filing planned for financial year 2018 [6].
Mar 18Filed in US for priority review for use as monotherapy and adjunctive use for partial-onset seizures (POS) with or without secondarily generalized seizures in paediatric patients (ages 2 to less than 12 years). The submission also proposes a paediatric indication for monotherapy and adjunctive use for primary generalized tonic-clonic seizures (PGTC) in children (ages 2 to less than 12 years) with epilepsy. The sNDA is for both the FYCOMPA tablet and oral suspension formulations [5].
Dec 17Will be filed in the EU via the centralised procedure [4].
Sep 16Q3 PIII study 311 starts [1].

Category

AMPA receptor antagonist
Epilepsy is about twice as common in children as in adults (about 700 per 100,000 in children under the age of 16 years compared to 330 per 100,000 in adults) [2].
Partial onset seizures (POS) or primary generalised tonic clonic seizures in children aged 4 to 12 years - oral suspension formulation
Oral

Further information

Yes

Trial or other data

Nov 19Results released from the PIII study (NCT02849626) show that the safety and efficacy of perampanel in pediatric patients was similar to that observed in patients 12 years of age and older. Median reductions in seizure frequency per 28 days were 40.1% (POS), 69.2% (PGTCS), and 58.7% (SGS). Corresponding 50% responder and seizure-freedom rates were 46.6% and 11.5% (POS), 63.6% and 54.5% (PGTCS), and 64.8% and 18.5% (SGS), respectively [9].
Oct 18PIII trial (NCT02849626) has completed recruitment & collection of primary outcome data [7].
Oct 16Eisai initiates a PIII trial with an extension phase to assess the efficacy, pharmacokinetics, safety and tolerability of an perampanel oral suspension as an adjunctive therapy in children (ages 4 to < 12 years) with inadequately controlled partial onset seizures (POS) or primary generalised tonic clonic seizures (E2007-G000-311; NCT02849626). The open-label, single-arm trial will enrol approximately 160 patients in the US, Europe, Japan and Asia. The primary endpoint will be safety and tolerability. Following the 23 week treatment phase in which patients will receive 2 – 16mg of perampanel orally once-daily, long term safety will be assessed during an extension phase. In Japan, pediatric patients with partial-onset seizures will be titrated to receive 2 - 12mg of perampanel orally once-daily [3].

Evidence based evaluations

FycompaLennox-Gastaut syndrome in adults and children aged from 2 years - oral suspension formulation

Information

Fycompa
Licence extension / variation
Eisai
Eisai

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Apr 22Development has been discontinued after the PIII trial was terminated in July 21 [11].

Category

AMPA receptor antagonist
Lennox-Gastaut syndrome is characterised by multiple types of epileptic seizures, a characteristic EEG with generalised slow spike-and-wave discharges, psychomotor delay and behavioural disorders. Onset is usually before the age of 8. Prevalence is about 2 per 10,000 in Europe. The number of children affected is not known with certainty but it may account for about 3% of all childhood epilepsies. Males are affected five times more often than females [3].
Lennox-Gastaut syndrome in adults and children aged from 2 years - oral suspension formulation
Oral

Trial or other data

Jul 21PIII trial (NCT02834793) terminated early after enrolling 70 patients. Reason for Eisai decision not stated [8].