FDAnews Drug Daily Bulletin

Sunovion’s Seizure Drug Clinches FDA Approval

Nov. 12, 2013

The FDA has approved Aptiom for the adjunctive treatment of partial-onset seizures related to epilepsy, Sunovion says.

Antony Loebel, Sunovion’s executive vice president and chief medical officer, on Friday touted the treatment’s once-daily immediate-release formulation as an alternative to existing therapies.

Aptiom (eslicarbazepine acetate) was approved based on three large Phase III safety and efficacy trials including more than 1,400 patients. Of those patients, 41 percent experienced a reduction in seizure frequency as compared to 22 percent of patients given a placebo.

The approval comes after a somewhat rocky development program, with a resubmitted NDA application following a complete response letter for the drug by its previous name, Stedesa, in March.

“We’re highly committed to this area and we’ve been working with the FDA for some time to bring this drug to patients who need it,” Fred Grossman, senior vice president for clinical development and medical affairs at Sunovion, told Drug Industry Daily Monday. 

Sunovion says the drug should be available in pharmacies by the second quarter of 2014.

The approval nod is the second for Sunovion this year, following FDA’s June supplemental approval of Latuda (lurasidone HCl) for bipolar depression. — Lena Freund

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