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Sunovion’s Aptiom (eslicarbazepine acetate) Receives FDA Approval for Expanded Indication to Treat Partial-Onset Seizures in Children and Adolescents 4 Years of Age and Older

Posted 20 Sep 2017 by Drugs.com

MARLBOROUGH, Mass.--(BUSINESS WIRE)--September 14, 2017 Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) to expand the indication for its antiepileptic drug (AED) Aptiom (eslicarbazepine acetate) to include treatment of partial-onset seizures (POS) in children and adolescents four to 17 years of age. Aptiom is also approved in the U.S. for the treatment of POS in adults. Aptiom is a once-daily, immediate release AED that can be taken whole or crushed, with or without food. “Despite being the most common seizure type in patients with epilepsy, there continues to be a critical need for new therapeutic options for partial-onset seizures, especially for children and adolescents,” said Steven Wolf, M.D., Director of Pediatric Epilepsy and Associate Professor of Neurology at Mount S ... Read more

Related support groups: Seizures, Epilepsy, Aptiom, Eslicarbazepine

Pot Compound Alters Levels of Seizure Drug in Epilepsy Patients

Posted 11 Aug 2017 by Drugs.com

FRIDAY, Aug. 11, 2017 – Scientists experimenting with the marijuana compound cannabidiol as an epilepsy treatment must evaluate any interactions with other anti-seizure drugs patients are taking, researchers report. The new research from the University of Alabama at Birmingham suggests cannabidiol affects blood levels of several anti-seizure drugs, especially clobazam. Cannabidiol (CBD) has shown promise as a potential anti-seizure compound in animal and human studies, the Alabama researchers said. They are testing it as a therapy for difficult-to-control epilepsy in 39 adults and 42 children. Other drugs that the participants are taking include clobazam (Onfi), topiramate (Topamax), rufinamide (Banzel), zonisamide (Zonegran), valproate (Depakote) and eslicarbazepine. Blood levels of some of the drugs changed significantly, but except for clobazam, they did not deviate from the ... Read more

Related support groups: Seizures, Topamax, Epilepsy, Topiramate, Qsymia, Seizure Prevention, Zonisamide, Zonegran, Seizure Prophylaxis, Cannabis, Valproic Acid, Phentermine/topiramate, Onfi, Aptiom, Depakene, Banzel, West Syndrome, Clobazam, Status Epilepticus, Lennox-Gastaut Syndrome

One-a-Day Anti-Seizure Drug Shows Promise for People With Epilepsy

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

Related support groups: Seizures, Epilepsy, Tegretol, Carbamazepine, Seizure Prevention, Tegretol XR, Seizure Prophylaxis, Carbatrol, Epitol, Aptiom, Equetro, Eslicarbazepine

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

Related support groups: Aptiom, Eslicarbazepine

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