Neupro(R) Filed with the FDA for the Treatment of Advanced-Stage Parkinson's Disease
Neupro(R) Filed with the FDA for the Treatment of Advanced-Stage Parkinson's Disease
Dec. 13, 2007 06:15 AM
BRUSSELS, BELGIUM -- (MARKET WIRE) -- 12/13/07 --
The U.S. Food and Drug Administration (FDA) has accepted for filing
the supplemental New Drug Application (sNDA) for the use of Neupro®
(Rotigotine Transdermal System) as adjunctive therapy with levodopa
in adult patients with advanced-stage Parkinson's disease
Brussels, December 13, 2007 at 7:00 am CET - UCB announced today that
the supplemental New Drug Application (SNDA) for the use of Neupro®
as adjunctive therapy with levodopa in adult patients with
advanced-stage Parkinson's disease has been accepted for filing by
the U.S. Food and Drug Administration (FDA).
The FDA has already approved Neupro® for the treatment of the signs
and symptoms of early-stage idiopathic Parkinson's disease and the
drug has been commercially available in the United States since July
2007.[1]
"We are excited that patients with all stages of Parkinson's disease
may soon benefit from Neupro®'s 24-hour continuous drug delivery,"
said Troy Cox, President CNS Operations, UCB.
The sNDA is based on efficacy and safety data in more than 670
patients with advanced-stage Parkinson's disease who were treated
with rotigotine in three double-blind, placebo-controlled clinical
trials. These studies demonstrated that rotigotine, as adjunctive
therapy to levodopa in patients with advanced-stage Parkinson's
disease, showed clinically relevant reductions in "off" time (periods
where the effectiveness of medications wear off and Parkinson's
symptoms return) and favorable increases in "on" time without
troublesome dyskinesia (fragmented or jerky movements). The most
frequently-reported adverse events in rotigotine clinical trials
included application site reactions, nausea, vomiting, dizziness,
somnolence and dyskinesia. [2],[3],[4]
"As these clinical studies have shown, continuous delivery of
rotigotine in a transdermal form can improve control of 'off' time in
advanced-stage Parkinson's patients throughout the day and night.
Once-daily dosing may improve compliance over medications that
require several daily doses," said Peter A. LeWitt, MD, Professor of
Neurology, Wayne State School of Medicine, and Director of the
Parkinson's Disease and Movement Disorders Program, Henry Ford
Hospital in Southfield, Michigan.
In Europe, Neupro® is already indicated for the treatment of the
signs and symptoms of early-stage idiopathic Parkinson's disease as
monotherapy and as adjunctive therapy with levodopa in advanced stage
Parkinson's disease.[5]
About Parkinson's Disease [6],[7],[8],[9]: Parkinson's disease is a
progressive disorder of the central nervous system. The patients -
roughly four million worldwide, including approximately one million
people in the United States - suffer primarily from a lack of
dopamine, a messenger substance in the central nervous system, which
is responsible for the coordination of movement. As a result of this
shortage, patients are no longer able to control their movements
reliably. Dopamine agonists are drugs that attempt to compensate for
this lack of dopamine.
About Neupro® in the USA [1],[6]: In the USA, Neupro® is indicated
for the treatment of the signs and symptoms of early-stage idiopathic
Parkinson's disease as monotherapy. Neupro® delivers the dopamine
agonist, rotigotine, directly from a patch into the bloodstream,
through the skin and offers stable, continuous delivery of rotigotine
24 hours-a-day. Rotigotine is a drug that mimics dopamine, a chemical
messenger that transmits impulses between nerve cells in the brain to
produce smooth, coordinated movement. Neupro® offers once-daily
dosing and a good tolerability profile.
Important Safety Information[1]
Some patients treated with Neupro® reported falling asleep while
engaged in activities of daily living, including operation of motor
vehicles, which sometimes resulted in accidents. Some patients
perceived no warning signs, such as excessive drowsiness.
Hallucinations were reported in 2.0% of patients treated with Neupro®
compared to 0.7% of patients on placebo. Neupro® should be used with
caution in patients, especially those at risk for cardiovascular
disease, because of the potential for symptomatic hypotension,
syncope, elevated heart rate, elevated blood pressure, fluid
retention, and/or weight gain. All Parkinson's disease patients are
at a higher risk for melanoma and should be monitored regularly. The
most commonly reported side effects in clinical trials ( > =5%) were
nausea, application site reactions, somnolence, dizziness, headache,
vomiting, and insomnia. Some subjects who received Neupro®
experienced a decline in blood hemoglobin levels (about 2% relative
to subjects who received placebo). It is not known whether this
change is readily reversible with discontinuation of Neupro®. For
full prescribing information, please visit www.neupro.com.
[2.] Quinn, N., on behalf of the European and South African
Rotigotine CDS Study Group. A Multicenter, Double-Blind, Randomized,
Placebo-Controlled Safety and Efficacy Study of Rotigotine Constant
Delivery System (CDS) in Patients with Advanced Parkinson's Disease.
Poster Presentation, International Conference on Parkinson's Disease,
August 2001.
[3.] Poewe, W. H., Rascol O., Quinn N., Tolosa E., Oertel W.
H ., Martignoni E., Rupp M. , Babak B., on behalf of the SP515
Investigators. Efficacy of pramipexole and transdermal rotigotine in
advanced Parkinson's disease: a double-blind, double-dummy,
randomised controlled trial. The Lancet Neurology - Vol. 6, Issue 6,
June 2007, Pages 513-520.
[4.] LeWitt, P., Lyons, K., Pahwa, R., Boroojerdi, B., et. al for the
SP650 Study Group. Transdermal Rotigotine in Combination with
Levodopa in the Treatment of Advanced Parkinson's Patients. Poster
Presentation, 132nd Annual Meeting of the American Neurological
Association, October 7-10, 2007.
[7.] Dorsey, E.R., et al. Projected Number of People with Parkinson
Disease in the Most Populous Nations, 2005 through 2030. Neurology,
2007; 68: 384:386. (available at
http://www.neurology.org/cgi/content/abstract/68/5/384)
UCB, Brussels, Belgium (www.ucb-group.com) is a global leader in the
biopharmaceutical industry dedicated to the research, development and
commercialization 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 around 12,000 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 (Monheim, Germany) is a member of the UCB
Group.
Further information
Antje Witte, Vice-President Corporate Communications & Investor
Relations, UCB
T +32.2.559.9414, Antje.witte@ucb-group.com
Mareike Mohr, Associate Director Investor Relations, UCB
T +32.2.559.9264, Mareike.mohr@ucb-group.com
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.
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