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'Off' Time Reduced By an Average of More Than Two Hours Per Day
RESEARCH TRIANGLE PARK, N.C., April 2 /PRNewswire/ -- Adding the once
daily, investigational medication REQUIP(R) (ropinirole HCl) XL 24-Hour(TM)
Extended-Release Tablets to Parkinson's patients' existing levodopa
(L-dopa) therapy significantly reduced 'off' time, allowing patients to
continue their daily activities for a longer period of time. 'Off time'
describes the return of Parkinson's symptoms as a patient's medication
wears off. The Ropinirole 24-Hour Prolonged Release Randomized, Controlled
Study in Advanced Parkinson Disease (EASE-PD Adjunct Study) results,
published in the April 3 issue of Neurology, show that adjunct treatment
with REQUIP XL 24-Hour significantly reduced 'off' time by an average of
more than two hours per day when compared to baseline prior to treatment.
"'Off' time is a common phenomenon for Parkinson's patients. When
symptoms like slowness of movement, tremor and rigidity return due to
wearing off of the patient's medication, it can be problematic, causing
difficulty with simple activities and movement in patients with Parkinson's
disease," said Rajesh Pahwa, M.D., Professor of Neurology, Director,
Parkinson Disease and Movement Disorder Center, University of Kansas
Medical Center, Kansas City, Kan., and lead investigator of the EASE-PD
Adjunct study. "These study results are significant, and show that with the
investigational REQUIP XL 24- Hour added to L-dopa, patients can have more
than two additional hours per day, on average, without experiencing the
disabling symptom of 'off ' time."
REQUIP(R) (ropinirole HCl) Tablets, the immediate-release (IR)
formulation, is dosed three times daily. REQUIP XL 24-Hour has been
designed to be given once daily and to have a simpler and faster titration
schedule. In addition, it has been designed to provide a steady rate of
absorption in the body to help reduce blood plasma fluctuations over 24
hours. In the EASE- PD Adjunct Study, REQUIP XL 24-Hour has been shown to
be effective in treating both motor and non-motor symptoms of Parkinson's
disease as an addition to L- dopa. GlaxoSmithKline sponsored this study as
part of the clinical development program for the investigational 24-hour
extended-release tablet dosage formulation of REQUIP. REQUIP XL 24-Hour is
the proposed brand name for a once-a-day formulation of ropinirole for
treating Parkinson's disease using SkyePharma Plc's (Nasdaq: SKYE; LSE:
SKP) proprietary GeoMatrix technology.
About the Study
The EASE-PD Adjunct study was a multi-center, double-blind, placebo-
controlled study, conducted in patients with idiopathic Parkinson's disease
not adequately controlled with L-dopa. Subjects were randomized (1:1) to
receive REQUIP XL 24-Hour (n=202) or placebo (n=191) in addition to L-dopa,
once daily for 24 weeks. The primary endpoint was mean change from baseline
in awake time spent 'off' (measured via patient diaries). REQUIP XL 24-Hour
decreased patients' awake time spent 'off' by an average of 2.1 hours per
day, while placebo decreased awake time spent 'off' by 0.3 hours per day.
The study also included a wide variety of motor and non-motor secondary
endpoints, including 'on' time which refers to the time during which
medication is working and providing benefit, and 'on' time without
troublesome dyskinesia which refers to 'on' time without involuntary
movements interfering with function or causing discomfort, a common problem
in Parkinson's disease. REQUIP XL 24-Hour significantly increased both 'on'
time and 'on' time without troublesome dyskinesia by 1.6 hours per day (a
greater than 12 percent increase) and reduced the percentage of 'off' time
by more than 12 percent compared to baseline. REQUIP XL 24-Hour also
improved sleep problems associated with Parkinson's disease, as measured by
the Parkinson's Disease Sleep Scale total score.
There were other motor and non-motor secondary endpoints in the study
publication that were statistically significant. However, there were no
significant differences between REQUIP XL 24-Hour compared to placebo in
PDQ- 39 subscales of social support, cognition or bodily discomfort.
Additionally, there was no significant difference between REQUIP XL 24-Hour
and placebo on the Epworth Sleepiness Scale total score signifying no
increase in daytime sleepiness.
In the EASE-PD Adjunct study, once daily use of REQUIP XL 24-Hour was
generally well tolerated. The withdrawal rate due to adverse events was low
and similar between the two groups (REQUIP XL 24-Hour 5 percent versus
placebo 5 percent). The most common adverse events reported in patients
taking REQUIP XL 24-Hour (n=202) versus placebo (n=191) were dyskinesia (13
percent versus 3 percent), nausea (11 percent versus 4 percent), dizziness
(8 percent versus 3 percent), somnolence (7 percent versus 4 percent),
hallucinations (6 percent versus 1 percent), and orthostatic hypotension (5
percent versus 2 percent).
A Progressively Disabling Disease
Parkinson's disease is a chronic, progressive and debilitating
neurological condition that impairs the body's ability to move and balance.
Researchers have determined that Parkinson's disease involves pathways in
the brain responsible for motor control that are functioning improperly.
Patients with Parkinson's disease experience a reduction in dopamine, a key
chemical in the brain that communicates messages about movement, resulting
in the symptoms of Parkinson's disease. These symptoms may include
bradykinesia (slower-than- normal voluntary movements), rigidity
(stiffness), tremor (involuntary shaking) and postural instability (trouble
with balance).
More than one million people in the United States have Parkinson's
disease, and it is estimated that nearly 60,000 new cases are diagnosed in
the U.S. each year. Most people develop Parkinson's disease between the
ages of 40 and 70, but the disease can also develop at an earlier age.
About REQUIP Tablets (Immediate-Release Formulation)
The currently marketed REQUIP Tablets, a non-ergot dopamine agonist,
has an indication in the U.S. for the treatment of the signs and symptoms
of idiopathic Parkinson's disease and is administered three times a day.
Prescription REQUIP is not for everyone. REQUIP Tablets may cause
patients to fall asleep or feel very sleepy during normal activities such
as driving; or to faint or feel dizzy, nauseated, or sweaty when they stand
up. Patients should tell their doctor if they experience these problems or
if they drink alcohol or are taking other medicines that make them drowsy.
Patients should also tell their doctor if they or their family notices that
they develop any unusual impulses or behaviors, such as pathological
gambling or hypersexuality. Hallucinations may occur at anytime during
treatment. REQUIP may potentiate the side effects of L-dopa. Side effects
include nausea, dizziness, drowsiness or sleepiness, headache, and
dyskinesia (uncontrolled movements). Most patients were not bothered enough
to stop taking REQUIP. This is not a complete list of side effects and
should not take the place of discussions with patients' healthcare
providers. Their doctor or pharmacist can give patients a more complete
list of side effects. Patients should talk to their doctor about any side
effects they may have.
About SkyePharma PLC
SkyePharma develops pharmaceutical products benefiting from
world-leading drug delivery technologies. The Company has nine approved
products in the areas of oral, inhalation and topical delivery that are
marketed throughout the world by leading pharmaceutical companies. For more
information, visit http://www.skyepharma.com.
About GlaxoSmithKline
GlaxoSmithKline, with U.S. operations in Philadelphia and Research
Triangle Park, N.C., is one of the world's leading research-based
pharmaceutical and health care companies.
Contacts:
Robin Gaitens Patricia Li
GlaxoSmithKline Cohn & Wolfe
919-483-2839 212-798-9772
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