FDA Accepts for Review OVATION’s Two NDA Submissions for Sabril®

Priority Review Granted for Infantile Spasms with Concurrent Review
for Refractory Complex Partial Seizures

OVATION Pharmaceuticals, Inc. announced on February 27, 2008, that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug applications (NDA) for Sabril® (vigabatrin) in two types of epilepsies. The FDA assigned a priority NDA review for Sabril for the treatment of Infantile Spasms (IS), and will review the submission for refractory complex partial seizures (CPS) in the same time frame. Sabril is currently under review by the FDA for use as a monotherapy for patients with IS and as an adjunctive treatment for adults with refractory CPS. A priority review designation is given to drugs that provide treatment where no adequate therapy exists, or that offer major advances in treatment.

To date, there are no medications approved by the FDA for the treatment of Infantile Spasms, a devastating form of epilepsy which usually strikes infants in the first year of life. In the United States, Infantile Spasms constitute about two percent of childhood epilepsies, and 25 percent of epilepsies with onset in the first year of life. Infants with IS suffer spasms that typically last for one to five seconds and occur in clusters of up to 100 spasms at a time.

Complex Partial Seizures are epileptic attacks that cause impaired consciousness and originate from a single region of the brain. About one-third of patients with CPS are unresponsive, or refractory, to treatment with many first- or second-line antiepileptic drugs (AEDs). In patients with refractory CPS, these treatments may only reduce the frequency and severity of the seizures, rather than providing complete seizure control.

Source: Adapted from a press release from Ovation Pharmaceuticals