Keppra XR Approved in the U.S.

[batman]

Found out about this via the Keppra XR Approved for Partial-Onset Seizures
For people 16 and older

[brain]

Just to add the quote:

Keppra XR Approved for Partial-Onset Seizures
For people 16 and older
By Scott Roberts

MONDAY, Sept. 15 (HealthDay News) -- The U.S. Food and Drug Administration has approved an extended release form of Keppra (levetiracetam) as an add-on treatment for people with epileptic seizures aged 16 and older, Belgian drug maker UCB said Monday.

"While many people with epilepsy are successfully treated with one or more of the currently available anti-epileptic drugs, a significant percentage still live with uncontrolled seizures or intolerable side effects," the company said in a news release.

Once-daily Keppra XR is expected to be available at U.S. pharmacies by the end of the month, UCB said. The original form was approved in 1999.

In clinical testing, the most common side effects included drowsiness and irritability, which also are common side effects of the drug's immediate-release form.

More than 3 million people in the United States have epilepsy, and more than 40 percent of people who take only a single anti-epileptic drug continue to have seizures, the company said.

[Bernard]

Here is the original press release:

Keppra XR™ approved in the U.S.

BRUSSELS, BELGIUM--(Marketwire - September 15, 2008) -

* As adjunctive therapy, Keppra XR offers significant partial
onset seizure reduction, proven tolerability, and once-daily
dosing

* Keppra XR is built on a trusted heritage

Brussels, BELGIUM - September 15, 2008 at 7:00 am CEST - press release, regulated information: UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Keppra XR™ (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™ is expected to be available in U.S. pharmacies at the end of September 2008.

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

"With solid clinical trial data supporting Keppra XR™ 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™ provided significant partial onset seizure control in once-daily dosing when added to other antiepileptic drugs and that it was generally well-tolerated."

Building On A Trusted Heritage

"This is one of many milestones at UCB to develop new treatment options for people with epilepsy," said Troy Cox, Senior Vice President UCB & President CNS Operations. "Keppra XR™ provides a way to simplify treatment and offers another chance to achieve seizure control, which is an important goal for patients living with epilepsy."

The immediate release tablet form of Keppra® (levetiracetam) was first approved by the FDA in 1999 as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Since then, Keppra® has become a leading antiepileptic drug in the U.S.

Important Safety Information

Keppra XR™ 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™ causes somnolence, dizziness, and behavioural abnormalities. The most common adverse reactions observed with Keppra XR™ combination with other anti-epileptic drugs were somnolence and irritability. The adverse reactions that may be seen in patients receiving Keppra XR™ are expected to be similar to those seen in patients receiving immediate-release Keppra® tablets.

Keppra® immediate-release tablets cause somnolence and fatigue, coordination difficulties, and behavioural 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® in combination with other anti-epileptic drugs were somnolence, asthenia, infection and dizziness.

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

Dosing must be individualized according to the patient's renal function state. 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® be used instead of Keppra XRTM.

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 the U.S. UCB Medical Information at 1-866-822-0068 (press 9).

[batman]

Let me try this again.

The first link I had posted was for the 'Epilepsy Wire: Comprehensive News Feed for Epilepsy', which is at...

www.topix.net/wire/health/epilepsy

and the second, was a direct link to the Keppra XR website, which is at...

www.keppraxr.com

At this moment, on the first page of the results for the 'Epilepsy Wire' site, I see that there are 5 separate listings that pertains to the Keppra XR. And each one of those listed are to separate news stories.