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Published on 7 March 2011

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FDA accepts clobazam new epilepsy application

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Onfi(TM) (clobazam) proposed as United States trade name
Lennox-Gastaut syndrome is one of the most severe forms of epilepsy and there is a clear need for new treatment options

If approved, clobazam has the potential to contribute to Lundbeck’s growth opportunities in the years to come

H. Lundbeck A/S (Lundbeck) has announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for the investigational compound clobazam as adjunctive therapy in treating seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years and older.

The filing was assigned a standard review and an action letter is anticipated in the fourth quarter 2011.

Additionally, Lundbeck announced that Onfi(TM) (pronounced “on-fee”) is the proposed trade name for clobazam in the US.

The NDA submission is based on a clinical development program that evaluated the safety and efficacy of Onfi as add-on therapy in patients with LGS.

Positive results from the largest clinical Phase III trial ever conducted in patients with LGS were presented at the December 2010 annual meeting of the American Epilepsy Society (AES).

“We are very pleased that we have submitted an NDA for Onfi as this will potentially provide patients suffering from Lennox-Gastaut syndrome in the US with a new treatment option,” said Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck.

He continued: “Lennox-Gastaut syndrome is a serious disease and most patients experience multiple types of seizures with periods of frequent seizures, and daily seizures are common. There is still a great need for improved therapies to offer patients.”

LGS is a rare and severe form of epilepsy that is typically diagnosed in childhood and often persists into adulthood.

Most patients with LGS experience multiple types of seizure with periods of frequent seizures, and daily seizures. Some of these seizures may cause falls, or “drop seizures,” which may result in injury.

Clobazam is a 1,5-benzodiazepine that potentiates the inhibitory action of gamma-aminobutyric acid (GABA) by binding to GABA-A receptors.

GABA-A receptors contain a benzodiazepine binding site, also referred to as the omega receptor , of which three subtypes have been identified.

In non-clinical studies, clobazam was shown to have higher affinity for the omega-2 compared to the omega-1 receptor.

The precise mechanism of action by which clobazam exerts its antiepileptic effects is unknown.

Clobazam is marketed outside of the US under various brand names, including Frisium® and Urbanyl®. Brand names listed are property of their owners.



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