Keppra XR(TM) Approved for Sale in US by FDA

Epilepsy is a chronic neurological disorder affecting approximately three million people in the US-making it more common than multiple sclerosis and Parkinson's disease combined. It is caused by abnormal, excessive electrical discharges of the nerve cells, or neurons, in the brain. Epilepsy is characterized by a tendency to have recurrent seizures and defined by two or more unprovoked seizures. There are many different seizure types and epileptic syndromes. Forty percent of patients taking only one AED continue to experience seizures, and approximately 30% of patients taking adjunctive therapy continue to experience seizures. This highlights the ongoing need for the development of new AEDs. For more information about epilepsy, visit www.epilepsyfoundation.org, www.epilepsy.com, or www.epilepsyadvocate.com.

PRNewswire --- UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Keppra XR(TM) (levetiracetam extended-release tablets) for use as an add-on to other antiepileptic treatments for people with partial-onset seizures who are 16 years of age and older. Keppra XR(TM) is expected to be available in U.S. pharmacies at the end of September 2008.

The goal of therapy with antiepileptic drugs (AED) is freedom from seizures and minimal side effects. While many people with epilepsy are successfully treated with one or more of the currently available antiepileptic drugs, a significant percentage still live with uncontrolled seizures or intolerable side effects.

"With solid clinical trial data supporting Keppra XR(TM) efficacy and tolerability, this once-daily antiepileptic drug can play an important role in treating people with epilepsy," said lead investigator Dr. Jukka Peltola, Department of Neurology, Tampere University Hospital, Finland. "We found in the clinical trial that Keppra XR(TM) provided significant partial onset seizure control in once-daily dosing when added to other antiepileptic drugs and that it was generally well-tolerated."

Important Safety Information

Keppra XR(TM) extended-release tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 16 years of age and older with epilepsy.

Keppra XR(TM) causes somnolence, dizziness, and behavioral abnormalities. The most common adverse reactions observed with Keppra XR(TM) in combination with other AEDs were somnolence and irritability.

The adverse reactions that may be seen in patients receiving Keppra XR(TM) are expected to be similar to those seen in patients receiving immediate- release Keppra(R) tablets.

Keppra(R) immediate-release tablets cause somnolence and fatigue, coordination difficulties, and behavioral abnormalities (e.g., psychotic symptoms, suicidal ideation, and other abnormalities), as well as hematological abnormalities. In adults experiencing partial onset seizures, the most common adverse reactions observed with Keppra(R) in combination with other AEDs were somnolence, asthenia, infection and dizziness.

Keppra XR(TM) should be gradually withdrawn to minimize the potential of increased seizure frequency.

Dosing must be individualized according to the patient's renal function status. The dosage should be reduced in patients with impaired renal function receiving Keppra XR. In patients with end stage renal disease on dialysis, it is recommended that immediate-release Keppra(R) be used instead of Keppra XR(TM).

For full prescribing information, please see www.KeppraXR.com.

In order to ensure patient access to this valuable medication in the U.S., UCB is initiating a co-pay support program. For more information, contact U.S. UCB Medical Information at 1-866-822-0068 (press 9).

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