ATLANTA, Dec. 3 /PRNewswire/ -- UCB today announced results of a Phase
III trial demonstrating that its antiepileptic drug (AED) in development
Keppra XR(TM) (levetiracetam) extended-release tablets significantly
reduced partial onset seizure frequency when administered as adjunctive
therapy for adults with refractory epilepsy. These data were presented
today at a scientific exhibit at the 61st annual meeting of the American
Epilepsy Society, Philadelphia.
"These data show that the once-daily, extended-release formulation of
Keppra(R) reduced the frequency of partial onset seizures in patients with
uncontrolled epilepsy and was generally well tolerated," said Iris
Loew-Friedrich, MD, PhD, Global Head of Development, UCB.
The Phase III, multicenter, randomized, double-blind,
placebo-controlled study evaluated 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,
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
"In this study with a new formulation of Keppra(R) about one in ten
patients with refractory partial onset epilepsy achieved seizure freedom,"
said Dr. Jukka Peltola, Department of Neurology Tampere University
Hospital, Finland. "There is an ongoing need for new antiepileptic drug
options and extended release formulations offer the potential advantages of
convenience and improved patient compliance."
UCB is in the process of submitting a New Drug Application (NDA) for
the use of Keppra XR(TM) in the adjunctive treatment of partial onset
seizures in adults with epilepsy to the U.S. Food and Drug Administration
About Epilepsy: Epilepsy is a chronic neurological disorder affecting
40 million people worldwide including 2.5 million people in the US. 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 US: Keppra(R) (levetiracetam) tablets were
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 co-
ordination 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.
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, owns approx. 89% of
the shares of SCHWARZ PHARMA AG. 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
SOURCE UCB, Inc.