Health & Medicine
Aptiom Receives FDA Nod to Treat Seizures in Adults
Benita Matilda
First Posted: Nov 09, 2013 06:48 AM EST
The U.S. Food and Drug Administration on Friday approved a new drug Aptiom as an add on medication to treat seizures in adults.
Marketed by Marlborough based Sunovion Pharmaceuticals, Aptiom (eslicarbazepine acetate) received a green signal from the U.S. FDA as an add-on medication to treat seizures linked with epilepsy. It is approved for the treatment of partial seizures.
"Some patients with epilepsy do not achieve satisfactory seizure control from existing treatments," Eric Bastings, M.D., acting director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "It is important we continue to make new treatment options available to patients."
Epilepsy is a set of chronic neurological disorders that is characterized by recurring seizures. It is a brain disorder that is triggered by the abnormal or excessive activity of the nerve cells in the brain. Seizures trigger a variety of symptoms like repetitive limb movements, unusual behavior and generalized convulsions with loss of consciousness. Such type of seizures can lead to injuries are sometimes fatal too. Nearly 200,000 new cases of seizures and epilepsy occur in the United States each year.
In order to test the safety of the drug, three clinical studies were conducted in which the subjects with partial epilepsy were randomly assigned to get either Aptiom or a placebo. At the end of the tests, it was seen that the drug Aptiom was effective in lowering the frequency of seizures.
The common side effects noticed were dizziness, drowsiness, headache, nausea, fatigue, double vision, vomiting and loss of coordination.
Similar to the other antiepileptic drug, Aptiom can also cause suicidal thoughts or actions in a limited set of people. If any patient experiences such thoughts, change in mood/behaviour, depression or anxiety, they are instructed to immediately contact their health care professionals.
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First Posted: Nov 09, 2013 06:48 AM EST
The U.S. Food and Drug Administration on Friday approved a new drug Aptiom as an add on medication to treat seizures in adults.
Marketed by Marlborough based Sunovion Pharmaceuticals, Aptiom (eslicarbazepine acetate) received a green signal from the U.S. FDA as an add-on medication to treat seizures linked with epilepsy. It is approved for the treatment of partial seizures.
"Some patients with epilepsy do not achieve satisfactory seizure control from existing treatments," Eric Bastings, M.D., acting director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "It is important we continue to make new treatment options available to patients."
Epilepsy is a set of chronic neurological disorders that is characterized by recurring seizures. It is a brain disorder that is triggered by the abnormal or excessive activity of the nerve cells in the brain. Seizures trigger a variety of symptoms like repetitive limb movements, unusual behavior and generalized convulsions with loss of consciousness. Such type of seizures can lead to injuries are sometimes fatal too. Nearly 200,000 new cases of seizures and epilepsy occur in the United States each year.
In order to test the safety of the drug, three clinical studies were conducted in which the subjects with partial epilepsy were randomly assigned to get either Aptiom or a placebo. At the end of the tests, it was seen that the drug Aptiom was effective in lowering the frequency of seizures.
The common side effects noticed were dizziness, drowsiness, headache, nausea, fatigue, double vision, vomiting and loss of coordination.
Similar to the other antiepileptic drug, Aptiom can also cause suicidal thoughts or actions in a limited set of people. If any patient experiences such thoughts, change in mood/behaviour, depression or anxiety, they are instructed to immediately contact their health care professionals.
See Now: NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone