FDA Approves Sunovion's Epilepsy Drug

The U.S. Food and Drug Administration has approved a new drug made by Sunovion Pharmaceuticals to reduce seizures associated with epilepsy.

The Marlborough-based company said it plans to make Aptiom available to U.S. pharmacies in spring 2014 as an add-on treatment for epilepsy.

The FDA will not classify Aptiom as a controlled substance, Sunovion said, since the drug isn't considered to have much of a potential for abuse. That means Aptiom won't be subject to additional review by the Drug Enforcement Administration and can be released onto the market sooner.

“Patients with partial-onset epilepsy often require adjunctive treatment to achieve better seizure control,” said Dr. Joseph Sirven, chair of the Epilepsy Foundation’s Professional Advisory Board, in a statement. “Aptiom is an important new treatment option with a well-established safety profile for healthcare providers and people living with epilepsy.”

Aptiom significantly reduced the frequency of seizures in clinical trials as compared with a placebo, the FDA found.

Epilepsy affects nearly 2.2 million Americans, according to the Centers for Disease Control and Prevention, with partial-onset seizures accounting for 60 percent of new diagnoses.

Updated at 4 p.m. to clarify FDA classification for Aptiom

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