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news.US-based Sunovion Pharmaceuticals (Sunovion) has introduced its once-daily antiepileptic drug (AED), Aptiom (eslicarbazepine acetate) into pharmacies across the US, which will be available to patients through prescription to be used for the treatment of partial-onset seizures
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Aptiom, a voltage-gated sodium channel blocker, is a new chemical entity approved by the US Food and Drug Administration (FDA) in November 2013, and is available in four tablet strengths (200mg, 400mg, 600mg and 800mg).
The tablets, which can be taken whole or crushed, with or without food, are not classified as a controlled substance by the FDA.
Thomas Jefferson University professor of Neurology Michael Sperling said epilepsy is a serious condition that not only affects the people who suffer from seizures, but also their family, caregivers and friends.
"Approximately one-third of those with epilepsy still have inadequate seizure control despite treatment, so we need new therapies," Sperling said.
"APTIOM is a welcome addition to our therapeutic toolkit that may help some patients."
The FDA approval was based on three pivotal Phase III randomized, double-blind, placebo-controlled trials.
The results of these trials showed that patients treated with Aptiom experienced significant reductions in standardized seizure frequency and significantly more Aptiom-treated patients showed seizure frequency reduction of 50% or more from baseline versus placebo.
In these trials, the drug was shown to have a favorable safety profile with a low incidence of severe adverse events when used as adjunctive therapy in adult patients with partial-onset seizures.
Most common side effects in patients taking Aptiom included dizziness, sleepiness, nausea, headache, double vision, vomiting, feeling tired, vertigo, problems with coordination, blurred vision and shakiness.
Sunovion executive vice president and chief commercial officer Rick Russell said Aptiom offers healthcare providers and patients living with partial-onset seizures a new adjunctive treatment option with once-daily dosing.
"Aptiom not only marks our entry into the epilepsy therapeutic area, but also reinforces our commitment to improving the lives of people living with CNS disorders," Russell said.