Sunovion Pharmaceuticals has announced that the 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 conducted by Sunovion. Data from the monotherapy trials, in addition to the data generated from the adjunctive trials, confirm that APTIOM is efficacious and well-tolerated as adjunctive or monotherapy treatment within a daily dose range of 800 to 1,600 milligrams. Prescribers now have greater flexibility to optimize clinical response and tolerability when using APTIOM to treat people with partial-onset seizures,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer, Sunovion Pharmaceuticals Inc., and Head of Global Clinical Development for Sumitomo Dainippon Pharma Group.
The approval of APTIOM as monotherapy for partial-onset seizures was supported by data from two pivotal Phase 3 clinical trials (Studies 093-045 and 093-046). Both trials met the pre-specified primary endpoint agreed upon with the FDA.
“Sunovion has an ongoing commitment to people living with epilepsy. This approval reinforces our track record of bringing CNS therapies to market,” said David Frawley, Senior Vice President and Chief Commercial Officer, Sunovion. “We believe that APTIOM provides an additional therapeutic option to a larger group of people with partial-onset seizures, since APTIOM can now be used both as a monotherapy, as well as an adjunctive treatment.”
“Epilepsy is a common medical condition. About a third of the approximately three million people in the U.S. who have epilepsy do not have fully successful treatment with current approaches,” said John Stern, M.D., Director, Epilepsy Clinical Program and Professor, UCLA Department of Neurology. “The approval of APTIOM as a monotherapy for partial-onset seizures is based on clinical studies that provide valuable information regarding the treatment of people with epilepsy."