FDA Approves Aptiom
FDA Approves Aptiom to Treat Seizures in Adults
November 8, 2013 -- The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.
Epilepsy is a brain disorder caused by abnormal or excessive activity in the brain’s nerve cells. Approximately 200,000 new cases of seizures and epilepsy occur in the United States each year.
Aptiom is approved for the treatment of partial seizures, the most common type of seizure seen in people with epilepsy. Seizures can cause a wide range of symptoms, including repetitive limb movements, unusual behavior and generalized convulsions with loss of consciousness. Seizures can have serious consequences, including injury and death.
“Some patients with epilepsy do not achieve satisfactory seizure control from existing treatments,” said Eric Bastings, M.D., acting director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “It is important we continue to make new treatment options available to patients.”
Three clinical studies in which participants with partial epilepsy were randomly assigned to receive Aptiom or placebo demonstrated that Aptiom is effective in reducing the frequency of seizures.
The most common side effects reported by patients receiving Aptiom in clinical trials included dizziness, drowsiness, nausea, headache, double-vision, vomiting, fatigue and loss of coordination. These and other side effects and recommendations for monitoring are described in the drug label.
Like other antiepileptic drugs, Aptiom may cause suicidal thoughts or actions in a very small number of people. Patients should contact their health care professionals right away if they have thoughts about suicide or dying, new or worsened anxiety or depression, or other unusual changes in behavior or mood.
Aptiom is being approved with a Medication Guide that provides patients with important information about the medication that can help patients avoid serious adverse events. The guide will be distributed each time a patient fills their prescription.
Source: FDAAptiom is marketed by Sunovion Pharmaceuticals Inc., based in Marlborough, Mass.
Posted: November 2013
- 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 - September 14, 2017
- FDA Approves New Indication for Aptiom (eslicarbazepine acetate) as Monotherapy for Partial-Onset Seizures - August 28, 2015
- Sunovion Announces FDA Acceptance for Review of New Drug Application Resubmission for Stedesa (eslicarbazepine acetate) as a Once-Daily Adjunctive Therapy for Partial-onset Seizures in Adults with Epilepsy - March 8, 2013
- FDA Provides Complete Response to Sepracor's New Drug Application for Stedesa - May 4, 2010
- FDA Extends PDUFA Action Date for Stedesa New Drug Application - January 29, 2010
- Sepracor's Stedesa (eslicarbazepine acetate) New Drug Application Formally Accepted for Review by the FDA - June 1, 2009
- Sepracor Announces Submission of Stedesa New Drug Application to FDA for Adjunctive Treatment of Epilepsy - March 31, 2009