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Posted 15 Apr 2016 by Drugs.com
THURSDAY, April 14, 2016 – A once-daily epilepsy drug may control seizures just as well as a twice-daily drug, researchers report. Their preliminary study compared the once-a-day drug eslicarbazepine acetate (Aptiom) to the twice-daily drug carbamazepine (Tegretol, Carbatrol) for more than 800 people newly diagnosed with partial seizures, which originate in one area of the brain. After six months, 71 percent of those taking eslicarbazepine and 76 percent of those taking carbamazepine were seizure-free. After one year, 65 percent of those taking eslicarbazepine and 70 percent of those taking carbamazepine were seizure-free, said the team led by Dr. Elinor Ben-Menachem, of Gothenburg University in Sweden. The study was funded by Portuguese drug maker BIAL-Portela & Ca., and will be presented April 19 at the American Academy of Neurology's annual meeting, in Vancouver. "Seizure control is ... Read more
FDA Approves New Indication for Aptiom (eslicarbazepine acetate) as Monotherapy for Partial-Onset Seizures
Posted 31 Aug 2015 by Drugs.com
Marlborough, Mass., August 28, 2015 – Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Aptiom (eslicarbazepine acetate) as monotherapy for the treatment of partial-onset seizures. This new approved indication allows Aptiom to be used as monotherapy in people who initiate treatment for the first time or convert from other antiepileptic drugs (AEDs) to Aptiom. Previously approved in 2013 by the FDA as adjunctive therapy for partial-onset seizures, Aptiom is the only exclusively once-daily non-extended release AED, which can be used alone or in combination with other AEDs in the treatment of partial-onset seizures. “We are pleased to have achieved FDA approval of a monotherapy indication for Aptiom, based on the results of two identically designed Phase 3 clinical studies con ... Read more