FDA Accepts For Review OVATION's Two NDA Submissions For Sabril(R)

Main Category: Epilepsy
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 29 Feb 2008 - 2:00 PDT

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OVATION Pharmaceuticals, Inc. announced 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.

"The FDA's acceptance of our Sabril NDA filings is a significant milestone for the company and for this development program as we continue to advance our late-stage central nervous system pipeline," said Jeffrey S. Aronin, OVATION President and Chief Executive Officer. "The Sabril program, along with other epilepsy compounds we have in development, reflect our commitment to exploring new treatment options for patients suffering from severe and catastrophic epilepsies, particularly where current treatment needs are not fully addressed."

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 anti-epileptic 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.

About Sabril (vigabatrin)

Vigabatrin was synthesized in 1974 as the first designer drug for epilepsy. It is an irreversible GABA-transaminase inhibitor that produces a two- to three-fold increase in brain levels of GABA, a substance in the brain that acts to inhibit epileptic seizures. Following oral administration, Sabril crosses the blood-brain barrier and is active within the central nervous system. It is rapidly and completely absorbed following oral administration with high bioavailability. In addition to the indications being reviewed by the FDA, Sabril is also being developed by OVATION in the United States as a treatment for cocaine and methamphetamine dependence and this program has received Fast Track designation from the FDA. Sabril is a registered U.S. trademark of OVATION.

About OVATION Pharmaceuticals

OVATION is a fast-growing biopharmaceutical company that develops, manufactures and markets medically necessary therapies to satisfy unmet medical needs for patients with severe illnesses. Headquartered in Deerfield, Ill., with products available in more than 85 countries, OVATION is committed to having a significant impact on patients' lives through its focus on central nervous system (CNS), hematology/oncology, and hospital-based therapies. The five new launches the company expects over the next five years will be fueled by its late-stage CNS pipeline, which is one of the most robust in the industry. OVATION has been recognized for excellence in the global pharmaceutical and biotechnology industries with the 2006 and 2007 "Pharma Company of the Year" award from Scrip magazine for small to mid-sized enterprises.

OVATION Pharmaceuticals

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