The US Food and Drug Administration (FDA) has approved use of the antiepileptic drug lacosamide (Vimpat, UCB) in tablets and oral solution (not intravenous injection) in children as young as 4 years with partial-onset seizures (POS), the company has announced.
The FDA approved lacosamide in 2009 as adjunctive therapy and 2014 as monotherapy for adults with POS.
The expanded FDA indication for lacosamide as monotherapy and adjunctive therapy in children from age 4 years is based on the principle of extrapolation of its efficacy data from adults to children and is supported by safety and pharmacokinetics data collected in children, the company said in a news release. Adverse reactions in pediatric patients are similar to those seen in adult patients, they note.
"Although there are many children and families severely affected by epilepsy, until recently there were few effective treatment options approved for childhood epilepsy. This has contributed to poor seizure control for many, which can be detrimental to overall quality-of-life," Raman Sankar, MD, PhD, chief of pediatric neurology, David Geffen School of Medicine at the University of California, Los Angeles, said in the release.
"The availability of Vimpat for children with epilepsy has the potential to change the lives of children and their families by providing an additional choice to support them in their epilepsy journey," Dr Sankar added.
For pediatric patients, physicians should prescribe the most appropriate formulation and strength according to weight and dose, the company advises. A maximum dose of 300 mg/day is recommended for pediatric patients weighing 50 kg or more.
A single loading dose may be initiated in patients when rapid attainment of lacosamide steady-state plasma concentration and therapeutic effect is warranted. Lacosamide should be administered under medical supervision with consideration of the potential for increased incidence of central nervous system adverse reactions, the company says.
Warnings and precautions on the drug include those for suicidal behavior and ideation, dizziness and ataxia, cardiac rhythm and conduction abnormalities, and syncope.
Full prescribing information is available online.
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Cite this: FDA Approves Oral Lacosamide (Vimpat) for Children With Epilepsy - Medscape - Nov 06, 2017.