Sunovion Pharmaceuticals has released results from a pooled analysis of three Phase III randomised, placebo-controlled trials (Studies 301, 302 and 304) assessing the safety and efficacy of once-daily Aptiom (eslicarbazepine acetate) as adjunctive treatment of partial-onset seizures.
According to the pooled Phase III trial results, Aptiom showed significant improvements in standardised seizure frequency for 800mg and 1,200mg once-daily dosages versus placebo and higher responder rates (50% and 75% reductions) with Aptiom treatment versus placebo at the same dosages.
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In November, the US Food and Drug Administration (FDA) had approved Aptiom as an adjunctive treatment of partial-onset seizures.
Sunovion senior vice-president of clinical development and medical affairs Fred Grossman said the strong clinical evidence presented supports the use of Aptiom as an adjunctive treatment option for people with partial-onset seizures whose seizures are not adequately controlled with their current antiepileptic drug treatment.
"There is a need for new therapies since approximately one-third of people with epilepsy continue to experience poor seizure control," Grossman said.
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Primary efficacy endpoint for all three Phase III Aptiom trials was standardised seizure frequency per four weeks during the maintenance phase, while secondary efficacy endpoints included relative change in seizure frequency from baseline and responder rates.
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By GlobalDataSafety endpoints in these trials included incidence of treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, serious adverse events (SAEs) and deaths.
A total of 1,400 patients with partial-onset seizures inadequately controlled by one to three concomitant antiepileptic drugs (AEDs) from 35 countries, including the US were involved in the 301, 302 and 304 studies of the Phase III trial.
All three studies included an eight-week baseline period, a two-week double-blind titration phase and a 12-week double-blind, fixed-dose management phase.
In the double-blind phase, patients were randomised equally to receive placebo or Aptiom once-daily at 400mg (Studies 301 and 302 only), 800mg or 1,200mg (all three studies).
The company said that significant effect was observed with Aptiom treatment at doses of 800mg once-daily in Study 301 and 302, but not in Study 304, and at doses of 1,200mg once-daily in all three studies.
The analyses of the pooled data for these Phase III studies were based on the modified intent-to-treat (mITT) population defined as all randomised patients who had taken at least one dose of the study medication and had at least one post-baseline seizure frequency assessment.
