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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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Medicine Compliance Aid Stability

VimpatUCB Pharma Ltd

UCB Pharma Ltd
Vimpat
Tablets f/c 50mg, 100mg, 150mg, 200mg
A2 · Amber 2No stability data is available, the manufacturer does not, or cannot recommend use in CAs but there are no theoretical concerns with the product.
No special precautions for storage
No special requirements for storage.
9 February 2015

Lactation Safety Information

Suitable alternative antiepileptic
Very limited published evidence of safety
22 June 2017

New Medicines

VimpatPrimary generalized tonic-clonic seizures - adjunctive therapy (all formulations)

Information

Vimpat
Licence extension / variation
UCB Pharma
UCB Pharma

Development and Regulatory status

Launched
Launched
Phase III Clinical Trials
December 2020
Dec 20Licence extension approved in EU [8].
Oct 20Recommended for EU approval by CHMP - the additional indication is as adjunctive therapy ... "in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy" [7].
May 20Currently pre-registration in the EU [5].

Category

New generation anticonvulsant with dual mode of action - a small-molecule voltage-gated sodium channel antagonist and CRMP2 protein modulator.
The prevalence of active epilepsy is 5-10 cases per 1,000 - but with 5-30% of these misdiagnosed as having epilepsy [1].
Primary generalized tonic-clonic seizures - adjunctive therapy (all formulations)
Intravenous and
Oral

Further information

Yes
To be confirmed

Trial or other data

Sep 20PIII VALOR trial (n=242) is published; risk of developing a second primary generalised tonic-clonic seizure (PGTCS) during 24-week treatment was significantly lower with lacosamide than placebo (Kaplan-Meier survival estimates 55.27%/33.37%; HR 0.540, 95% CI 0.377 to 0.774; p50% of patients did not experience a second PGTCS) and was 77 days for placebo [6].
Nov 19PIII VALUE trial (NCT02408549) has completed recruitment and is due to finish collecting primary outcome data in Dec 23 [4].
Jun 19PIII VALOR trial (NCT02408523) completes [4].
Mar 19PIII VALOR trial (NCT02408523) is recruiting [2].
Mar 19PIII VALUE trial (NCT02408549) is enrolling by invitation. Data collection is expected to complete Jan 24 [2].
May 15PIII VALUE trial to evaluate the long-term safety and efficacy of oral lacosamide as an adjunctive therapy for the treatment of uncontrolled generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy starts (EP0012; NCT02408549). 200 patients will be enrolled from the VALOR (SP0982) trial [2].
Apr 15PIII VALOR trial to evaluate the safety and efficacy of lacosamide (50mg tablet and 10 mg/ml oral solution) as an adjunctive therapy for the treatment of uncontrolled generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy, compared with placebo, starts (SP0982; NCT02408523). 200 patients aged 4 years and older will be recruited in countries including the US & EU (but not UK). Primary outcome is time to the second primary generalized tonic clonic (PGTC) seizure during the 24-week treatment period from Visit 2 (Week 0) to Visit 10 (Week 24); collection of these data is due to complete Apr 19 [2].

Evidence based evaluations

VimpatPartial onset seizures with or without secondary generalisation - adjunctive therapy in children from 1 month until 4 years of age with epilepsy

Information

Vimpat
Licence extension / variation
UCB Pharma
UCB Pharma

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

New generation anticonvulsant with dual mode of action - a small-molecule voltage-gated sodium channel antagonist and CRMP2 protein modulator.
Epilepsy is a common neurological disorder in childhood. Seizures and epilepsy affect infants and children more than any other age group. 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) [1].
Partial onset seizures with or without secondary generalisation - adjunctive therapy in children from 1 month until 4 years of age with epilepsy
Oral