The US Food and Drug Administration (FDA) has approved anticonvulsant Potiga (ezogabine) tablets as an add-on drug for the treatment of partial seizures in adults with epilepsy. The active ingredient was approved by EMA (European Medicines Agency) on March 28th 2011 under the trade name Trobalt.
Ezogabine is expected to be available in U.S. pharmacies by the end of the year.
Patients with epilepsy have a tendency to have recurrent seizures (fits). They occur because of a sudden spurt of electrical activity in the brain, the brain is literally overloaded. The messaging systems between brain cells become temporarily disturbed.
Parital seizures affect only a localized area of the brain – however, they can spread to other parts of the brain. Seizures can range from spasms (limb movements), bizarre behavior, and generalized convulsions during which the patient loses consciousness.
Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said:
“About one third of people with epilepsy do not achieve satisfactory seizure control from treatments they are currently using. It is important to have a variety of treatment options available for patients with epilepsy.”
Developers of Potiga, Valeant Pharmaceuticals, says this is the first neuronal potassium channel opener developed for epilepsy treatment. Although scientists are not completely sure what its mechanism of action is, the medication probably acts as an anticonvulsant by activating a certain family of voltage-gated potassium channels in the brain – a unique mechanism of action among antiepileptic drugs. Valeant might also be a potential treatment for migraine, neuropathic pain and some other neurologic conditions.
Common adverse reactions, according to clinical trial data, include dizziness, confusion, vertigo, tremor, coordination problems, double vision, attention difficulties, dizziness, memory impairments, and lack of strength.
Patients taking Potiga may experience urinary retention. If it does occur, it will usually do so during the first six months of treatment. Doctors should carefully monitor symptoms related to urinary retention, such as difficulties in starting urination, weak urine stream, or pain during urination. This is a unique side-effect among anti-convulsants.
Other symptoms, such as hallucinations, confusion, and psychotic symptoms are possible, but usually resolve within a week.
As is the case with other antiepileptic medications, Potiga can cause suicidal thoughts or actions (rare). Patients with such symptoms should contact their doctor immediately.
Potiga comes with a Medication Guide that provides the patient with important data on the drug. Each time a patient fills their prescription they will be given the guide.
Although Valeant Pharmaceuticals North America of Durham, N.C. developed Potiga, it will be distributed by GSK (GlaxoSmithKline).
Susan Hall, PhD, head of research and development at Valeant, said:
“We are so pleased to reach such an important milestone with the US approval of Potiga by the FDA. We believe this product will play a needed role in the management of partial onset seizures in appropriate patients who are uncontrolled on their current medications.”
Written by Christian Nordqvist