Navigation Links
Keppra XR(TM) Extended-Release Tablets Filed with the FDA
Date:1/16/2008

U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for the use of Keppra XR(TM) (levetiracetam) in the adjunctive treatment of partial onset seizures in adults with epilepsy

ATLANTA, Jan. 16 /PRNewswire/ -- UCB announced today that the New Drug Application (NDA) for the use of Keppra XR(TM) (levetiracetam) extended- release tablets in the adjunctive treatment of partial onset seizures in adults with epilepsy has been accepted for filing by the U.S. Food and Drug Administration (FDA).

"This filing is another important step in the development of UCB's epilepsy franchise and demonstrates our commitment to bringing new and innovative therapies to the epilepsy community," said Iris Loew-Friedrich, MD, PhD, Global Head of Development, UCB Group. "There is an ongoing need for new antiepileptic drug options without the limitations of twice daily dosing. Epilepsy therapies with more convenient dosing schedules may help encourage greater patient compliance, which is important to effective seizure control."

The filing for Keppra XR(TM) is supported by a Phase III, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of extended-release levetiracetam tablets (2x500 mg) once-daily as adjunctive therapy in 158 refractory epilepsy patients, 12 to 70 years of age, with partial onset seizures.

The study met its primary endpoint for seizure reduction over placebo during the treatment period (p=0.038). The median percent reduction of partial onset seizures in the extended-release levetiracetam group was 46.1% compared to 33.4% with placebo during the 12 week treatment period. Additionally, 24.0% of patients randomized to the extended-release levetiracetam group had seizure frequency per week reduced by 75-100%, compared with 11.4% of patients in the placebo group. In the extended-release levetiracetam group 10.1% of patients had 100% reduction in partial onset seizures and 8.9% were free from any type of seizure over the treatment period, compared to 2.5% and 1.3% in the placebo group, respectively.

The study also found that extended-release levetiracetam tablets were generally well tolerated. The most common reported adverse events that occurred more frequently in the extended-release levetiracetam group were somnolence, influenza, nausea, nasopharyngitis, irritability, and dizziness.

About Epilepsy: Epilepsy is a chronic neurological disorder affecting 40 million people worldwide including 2.5 million people in the U.S. 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, and effective classification guides treatment and prognosis. Between 70-80% of individuals are successfully treated with one of the more than 20 antiepileptic drugs now available. However, 20-30% of patients have either intractable or uncontrolled seizures or significant adverse side effects secondary to medication highlighting the ongoing need for the development of new antiepileptic drugs.

About Keppra(R) in the U.S.: Keppra(R) (levetiracetam) tablets were first approved by the FDA in 1999 as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Since 1999, Keppra(R) has received several supplemental indications as adjunctive therapy for epilepsy, making it one of the few treatments approved to treat seizure types that together account for more than 80 percent of all seizures.

Important Safety Information

Keppra(R) tablets and oral solution are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy, myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. Keppra(R) injection is indicated as adjunctive therapy in the treatment of myoclonic seizures in juvenile myoclonic epilepsy and partial onset seizures in adults with epilepsy. Keppra(R) injection is an alternative for patients when oral administration is temporarily not feasible.

Keppra(R) tablets and oral solution are associated with the occurrence of central nervous system adverse events including somnolence and fatigue, behavioral abnormalities, as well as hematological abnormalities. In adults experiencing partial onset seizures, Keppra(R) is also associated with coordination difficulties. In adults experiencing partial onset seizures, the most common adverse events associated with Keppra(R) in combination with other AEDs were somnolence, asthenia, infection and dizziness. In pediatric patients 4-16 years of age experiencing partial onset seizures, the most common adverse events associated with Keppra(R) in combination with other AEDs were somnolence, accidental injury, hostility, nervousness and asthenia. In patients 12 years of age and older with juvenile myoclonic epilepsy, the most common adverse events associated with Keppra(R) in combination with other AEDs were somnolence, neck pain, and pharyngitis. In patients 6 years of age and older with idiopathic generalized epilepsy, the most common adverse event associated with Keppra(R) in combination with other AEDs was nasopharyngitis.

The adverse events that result from Keppra(R) injection use for myoclonic seizures in juvenile myoclonic epilepsy and partial onset seizures in adults include all of those associated with Keppra(R) tablets and oral solution.

U.S. prescribing information is available at http://www.keppra.com or by calling 1-866-822-0068.

Further information

Andrea Levin

Public Relations Manager, CNS, UCB

T 770.970.8352

M 404.483.7329

Andrea.levin@ucb-group.com

Sarah Handza

Cooney/Waters Group

T 212.886.2206

M 646.236.1458

Shandza@cooneywaters.com

About UCB

UCB, Brussels, Belgium (http://www.ucb-group.com) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialisation of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. UCB focuses on securing a leading position in severe disease categories. Employing more than 10,000 people in over 40 countries, UCB achieved revenue of 3.5 billion euro in 2006 on a pro forma basis. UCB S.A. is listed on the Euronext Brussels Exchange and through its affiliate. SCHWARZ PHARMA AG (Monheim, Germany) is a member of the UCB Group.

Forward-looking statement

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.


'/>"/>
SOURCE UCB
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. UCB Announces Positive Phase III Trial Results for Keppra XR(TM) (levetiracetam) Extended-Release Tablets
2. SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia
3. AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression
4. New Data Show Improvements in Work Performance in Patients with Chronic Insomnia Treated with AMBIEN CR(R) (zolpidem tartrate extended-release) Tablets CIV
5. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
6. A Phase II, Randomized, Double Blind, Placebo-Controlled Dose-Escalating Study, Meets the Clinical Endpoints of MTR106 Tablets During the Treatment of Acute Migraine Attacks Without Aura in Females
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/7/2016)... 7, 2016  Lannett Company, Inc. (NYSE: LCI ) ... Markets 2016 Prescription for Success Healthcare Conference on December 14, 2016 ... New York City . In addition, the ... Guggenheim Securities 4 th Annual Boston Healthcare Conference taking place ... ...
(Date:12/6/2016)... , Dec. 6, 2016 Radioisotopes are ... Radioisotopes are produced either by using nuclear research reactor ... the form of alpha, beta or gamma when changed ... are used in Nuclear medicine, specifically in medical diagnostics. ... diagnostic information about a human body,s functioning. Radiotherapy is ...
(Date:12/6/2016)... Dec. 6, 2016 Human Vaccines Market: ... region wise and country wise analysis of the ... manufacturers of human vaccines products, raw material suppliers, ... enter the market. The report provides qualitative ... market. Qualitative analysis comprises market dynamics, trends, product ...
Breaking Medicine Technology:
(Date:12/7/2016)... ... December 07, 2016 , ... “Tomorrow Trump Goes To Washington”: ... greatness back to the presidency and to America. “Tomorrow Trump Goes To Washington” is ... much as she can for this country. , Nancy attributes her patriotic nature to ...
(Date:12/7/2016)... ... 2016 , ... “Fred Rides a Train” allows readers to tag along on ... Rides a Train” is the creation of published author, Janet Morrison, who has been ... Michigan. The "Fred, the Dog" series is her first attempt at writing for children. ...
(Date:12/7/2016)... ... December 07, 2016 , ... ... annual Business Architecture Innovation Summit in Reston, VA on March 21-22, 2017. This ... share a range of experiences from a cross-section of industries such as financial ...
(Date:12/7/2016)... ... December 07, 2016 , ... NuevaCare, a leading home ... is proud to announce new city-specific pages as part of its ambitious website relaunch. ... they often look, first, for local agencies serving their city. The new site has ...
(Date:12/6/2016)... ... 06, 2016 , ... People with Parkinson’s disease and cognitive ... type of MRI, according to a study appearing online in the journal Radiology. ... characterized by tremors or trembling and stiffness in the limbs, impaired balance and ...
Breaking Medicine News(10 mins):