Lawrence Epstein.
NEW YORK, How many people have vowed to
get a
better sex life this New Year? Or perhaps just get more sleep in the New Year?
According
to Dr.
Snoring can also signal a more serious sleep-breathing problem, sleep
apnea, which
in some cases, like former pro football great Reggie White, can
lead to death. Commencement
Triggers $10 Million Milestone Payment From Astellas
SANTA CLARA, Calif. Forward-looking
statements involve risks and uncertainties.
It also lists smaller, general information sites as well
as sites that provide short and concise general sleep disorders information.
disturbed zzz
----
Provides Patients
with Convenient Local Clinical Evaluation,
Treatment, Follow-up
Sleep HealthCenters(R), a
network of specialized sleep medicine
centers and the largest provider of such services in Massachusetts
,
has announced it has expanded its Malden Sleep HealthCenter affiliated
with Hallmark Health.
Sleep HealthCenters has other locations throughout eastern
Massachusetts and is affiliated
with the Brigham + Women's Hospital,
Beth Israel Deaconess Medical Center, McLean Hospital, and Faulkner
Hospital, as well as Hallmark Health.
Besides gabapentin, the metabolic breakdown products of
XP13512 are molecules
that have undergone extensive safety testing and are found naturally in
mammals
and in food. In addition to RLS,
XP13512 has been shown in a Phase 2a clinical trial to be effective
for the
management of post-herpetic neuralgia, a form of neuropathic pain. Patients who suffer
from
RLS experience an irresistible urge to move their legs. These forward-looking
statements are based
upon XenoPort's current expectations. Shift-work sleep disorder and jet-lag are well-known problems
that reflect the activity of the biological clock.
368 coincided
. This trial is anticipated to enroll
approximately
200 patients and is being conducted at multiple U.
A second multi-center, randomized, double
-blind, placebo-controlled trial
(Study XP053) is intended to evaluate the safety and efficacy of
600 mg and
1200 mg of XP13512 administered once a day at approximately 5:00 PM for 12
weeks.
XenoPort also plans to conduct an open-label safety trial of XP13512 in
RLS patients with a duration
of treatment extending up to 12 months. This urge is
usually accompanied by unpleasant sensations
of burning, creeping, tugging or
tingling inside the patients' legs, ranging in severity from uncomfortable
to
painful. Words such as "believes," "anticipates," "plans,"
"expects," "will," "intends,"
"potential," "possible" and similar expressions
are intended to identify forward-looking statements
.
This category consists of some of the major 'omnibus' sites (SleepNet, Brain Information Service
, Sleep Medicine and the SleepWell) that can contain just about everything (information, chats, consultations
, portals, etc).
kls snoring
Forward-Looking Statements
This press release contains "forward-looking
" statements, including,
without limitation, all statements related to our future clinical development
programs for XP13512 and XP19986 and the timing thereof; the therapeutic and
commercial potential
of XP13512 and XP19986; future clinical development
plans; and our future clinical trials.busting advisable
Dr. Sheldon
Randall, who practices at Lawrence Memorial Hospital,
is Medical Director of that hospital's Weight
Management Program, and
is a general and bariatric surgeon, refers his patients to the Malden
Sleep
HealthCenter for diagnosis of suspected sleep disorders. To learn
more about Sleep HealthCenters
, visit www.
That means one out of every two couples struggles to get a good night's rest.S.com.368 kls
Any statements contained in this press
release that are not statements of historical fact may be
deemed to be
forward-looking statements. XenoPort's actual results and the
timing of events could
differ materially from those anticipated in such
forward-looking statements as a result of these
risks and uncertainties, which
include, without limitation, the ability of the company to successfully
conduct clinical trials for XP13512 and XP19986; the uncertainty of the FDA
approval process and
other regulatory requirements; and the therapeutic and
commercial value of the company's compounds
. neurology, pulmonology, psychiatry, may be influential in other countries.
snorer sleepwalking
The facility is located
at 100 Hospital Road on the third floor of the Malden Medical Center.
With the addition of the
new clinic, the Malden Sleep HealthCenter
now offers comprehensive sleep medicine services, from
diagnosis to
treatment and follow-up.
Our clinicians are highly trained, very experienced in the
treatment
of sleep disorders, and have access to the most up-to-date tools and
information available
.XenoPort Initiates Phase 3 Clinical Program for XP13512 as a Treatment for Restless Legs Syndrome
, XenoPort's partner for developing
and commercializing XP13512 in Japan and five other Asian countries
., XenoPort's chief executive officer, stated, "The
commencement of our first Phase 3 clinical trial
is an important milestone for
XenoPort. Studies XP053 and
XP060 and the open-label safety trial
are all expected to commence later this
year. Phase 1 clinical trials in healthy volunteers have
demonstrated that, in contrast to Neurontin, oral administration of XP13512
produces dose-proportional
blood levels of gabapentin across a broad range of
doses.busting norms
This is very important, because, if not
diagnosed and
treated, this group is at great risk of other health problems. The
clinic will make
follow-up care very easy for them. Services are covered by most medical insurance
plans.com. The
inclusion of a 600 mg dosing group in this trial will enable an
evaluation of the effectiveness of
this dose after 12 weeks of treatment and
is expected to provide useful information for studying
the
pharmacokinetic/pharmacodynamic relationship for XP13512 in RLS. XenoPort's most advanced product
candidate, XP13512, has
commenced a Phase 3 clinical program for the treatment of restless legs
syndrome
, or RLS, and has successfully completed a Phase 2a clinical trial for
the management of post-herpetic
neuralgia. Sleep is affected by the brain's biological clock and so is included in this category.
advisable drowsy
"
Sleep
HealthCenters maintains close contact with a patient's own
referring physician throughout the entire
process, providing reports
on a regular basis.
These and other risk factors are
discussed
under the heading "Risk Factors" in our Quarterly Report on Form 10-
Q for the quarter ended September
30, 2005, filed with the Securities and
Exchange Commission on November 3, 2005.
The Organisations
sub-category is packed with information that is more specific to particular sleep disorders.
Apart from
listing the various centers, the Sleep Centers sub-category is worth visiting as many of these sites
provide useful information on sleep disorders.
narcolepsy apnea
com
All trademarks and registered trademarks mentioned
are the
property of their respective owners.
Anyone with health concerns is reminded that it
is advisable to discuss their problems with a licensed medical professional.
enuresis pulmonology
"
Dr."
The Medical
Director of the Malden Sleep HealthCenter, Dr.
Epstein, added, "We are very excited that we can now
offer patients
with sleep problems comprehensive, all-in-one services here in Malden. To inquire
about services at the
Malden Sleep HealthCenter, call 877-SLEEPHC (877-753-3742). For more information
, visit
http://www.
Top-line results from Study XP052 are expected in the first half of 2007.
Two different Phase 2 clinical trials have
demonstrated that treatment with XP13512 was associated
with a highly
statistically significant improvement in RLS symptoms.zzz coincided
"I had a great
experience
when I had my sleep study done at the Malden lab. Michael Gelb, one of the nation's leading specialists
in
sleep apnea and snoring:
-- People who snore have less active sex lives than those
who don't
-- Out of more than 1,000 men and women surveyed, 81 percent of the
partners
of snorers said they don't get a good night's sleep and are
constantly tired, making them
less likely to have the energy for
intimacy.
-- Of those snoring couples, researchers
said 70 percent resort to
sleeping in separate bedrooms to get some rest
-- Holiday
alcohol consumption can make the problem worse
Dr., XenoPort, Inc.
Ronald W.
The co-primary outcome measures for Studies XP052 and XP053 are defined to
be the change from
baseline in the International Restless Legs Syndrome rating
scale and the Clinical Global Impression
of Improvement at the end of
treatment. The
results of this trial, combined with those from other
XP13512 clinical trials
in RLS patients, are intended to meet the International Committee for
Harmonization
, or ICH, guidelines for safety assessment.
Left untreated, RLS may cause exhaustion, daytime fatigue
, inability to
concentrate and impaired memory. XenoPort has also completed two
Phase 1 clinical
trials of XP19986, a Transported Prodrug of R-baclofen.sleepwalking zzz
Barrett, Ph. The initial Phase 3 trial (Study
XP052) is a
randomized, double-blind, placebo-controlled trial that is designed to
evaluate the
safety and efficacy of 1200 mg of XP13512 administered once a day
at approximately 5:00 PM for 12
weeks. A dose of
600 mg of XP13512 was not effective after two weeks of testing in RLS patients
in XenoPort's prior Phase 2b clinical trial.
A third clinical trial (Study XP060) is intended
to evaluate the long-term
efficacy of XP13512 using a placebo-controlled, "randomized withdrawal
" design
to evaluate relapse of RLS symptoms in XP13512-treated or placebo-treated
patients who
had previously achieved clinical improvement while taking 1200 mg
of XP13512 for 24 weeks.
About XP13512
XP13512 is a Transported Prodrug of gabapentin, a drug that has been sold
by
Pfizer Inc as Neurontin since 1993 and is currently sold as a generic drug
by a number of companies
. Although the exact prevalence rate of RLS is
uncertain, a recent study has indicated that approximately
10% of patients
visiting primary care physicians in five industrialized Western countries
experience
RLS symptoms at least weekly, with approximately 2% of patients
visiting primary care physicians
having symptoms severe enough to disrupt
their quality of life.kls norms
We look forward to the results from
our Phase 3 clinical program and
the possibility of providing a new treatment alternative for patients
with
RLS. Secondary endpoints include onset of efficacy and subjective
sleep, pain, mood and
quality of life assessments.
Symptoms often worsen at night, and disturbed sleep is a common result
of RLS. XenoPort has commenced a
Phase 2a clinical trial of XP19986 in gastroesophageal reflux disease
, or
GERD, patients.advisable terrors
Sleep HealthCenters in Malden Adds New Clinic to Expand Patient Services for Those
with Sleep Disorders
. Since obtaining the positive results of our Phase 2 RLS trials last
year
, we have scaled-up the manufacturing of XP13512 tablets, recruited
clinical sites and advanced our
discussions with the FDA.XenoPort.g.
kls busting
The commencement of this Phase 3 clinical trial triggers a milestone
payment
of $10 million from Astellas Pharma Inc.D. These RLS-related symptoms typically begin or
worsen during periods
of rest or inactivity, particularly when lying down or sitting, and may be
temporarily relieved by movement such as walking or massaging the legs.Sleep research and sleep medicine
have grown rapidly over the last thirty years, partly as a result of the discovery that REM (rapid eye
movement) sleep coincided with dreaming and partly because of the discovery of sleep apnea (breathing
stopping during sleep).
sleep drowsy
The addition of the new four-room clinic enables
the Malden Sleep HealthCenter
to provide a full range of services for
patients suspected of having sleep disorders.
Patients
with any type of sleep disorder, including insomnia, OSA,
excessive daytime sleepiness, and restless
legs syndrome can be
evaluated and treated at the Malden facility.
"The new clinic is going to
be so convenient for me, as well as other
people who live in the Malden area," she said.sleephealth
.enuresis busting
Quiet the snore if you want to get a little more. Gelb says patients routinely come to
him in an effort to turn their
lives -- and their marriage beds -- around."
XP13512 Phase
3 Program in RLS
XenoPort's Phase 3 clinical program is intended to provide safety and
efficacy
data to support the filing and approval of a New Drug Application for
XP13512 as a treatment for
RLS. Additional Phase 1 clinical trials with a sustained-release
formulation of XP13512 have demonstrated
that, compared to equivalent doses of
Neurontin, XP13512 produced higher levels of gabapentin in
the blood for a
longer period of time.
The sleep disorders category is broadly divided into
sub-categories that deal with the specific sleep disorders as well as the institutions that regulate
, diagnose and treat these disorders.
advisable 368
Jonathan
Strongin and Margaret Trussler, nurse practitioner
. I look
forward to enjoying the same level of help and service at the new
clinic. He
commented
, "The sleep lab is a great resource for local patients, as
well as for the bariatric population in
identifying sleep apnea prior
to surgery."
Moreover, not getting a good night's rest often
means poor overall heath,
lower productivity on the job and more danger on the roads. A new study
carried out by Technion, the Israel Institute of
Technology, shows that men aged 20 to 29 with severe
sleep apnea have 10 times
the risk of dying from heart related ailments than their peers, and are
, in
fact, at a much higher risk than older men with sleep apnea. XP13512
was well tolerated in
all prior clinical trials.
To learn more about XenoPort, please visit the web site at
http:
//www.
advisable paralysis
Business Editors/Health/Medical Writers
MALDEN, Mass.
Dr. sleep medicine is recognised as a field and it is looked after by the National Heart, Lung and
Blood Institute; other medical specialities e.
polysomnography snorer
gelbcenter.
(Nasdaq: XNPT) announced today that it
has initiated its first Phase 3
clinical trial of XP13512 as a treatment for restless legs syndrome
, or RLS. sites. XP13512 utilizes high-capacity transport mechanisms
to be well absorbed in the small
and large intestines and is designed to then
rapidly convert to gabapentin upon absorption from the
gastrointestinal tract.
About XenoPort
XenoPort, Inc.busting enuresis
The center is staffed by
experts in the field of sleep medicine,
headed by Medical Director Dr. Yocasta Valdez, who
recently
had a sleep study done at the Malden Sleep HealthCenter, said
she was very pleased that she will
now be able to receive her
follow-up care right in town, rather than needing to travel elsewhere
. Gelb. Gelb is the director of the renown Gelb Center in NYC and has studied
breathing related sleep
disorders (BRSD), specializing in how they relate to
fatigue, focus, pain and the effects all of
these can have on a person's
overall performance and sex life.
About Restless Legs Syndrome
, or RLS
Restless legs syndrome is a common, under-diagnosed neurological disorder
that frequently
manifests itself as a sleep disorder.drowsy sleepnet
Services offered at the new clinic include
physician consults
, set ups for special equipment for obstructive
sleep apnea (OSA) patients, such as CPAP (Continuous
Positive Airway
Pressure) devices, patient monitoring and education.
These trials demonstrated
that a prototype formulation of XP19986 was suitable
for twice-a-day dosing and was well tolerated
with few adverse events at the
doses expected to be used in future clinical trials. XenoPort expressly
disclaims any
obligation or undertaking to release publicly any updates or revisions to any
forward
-looking statements contained herein to reflect any change in the
company's expectations with regard
thereto or any change in events, conditions
or circumstances on which any such statements are based
.norms sleepwalking
Get a Better Sex Life in the New Year
"Snoring and sleep apnea dramatically affect the lives
of individuals and
couples," said Dr. "Fifty percent of all men over the age of 50 snore.
NOTE: XenoPort and Transported Prodrug are trademarks of XenoPort, Inc.S.
narcolepsy 368
Kelly Carden is
Associate
Medical Director of the sleep clinic, joined by Dr. The initiation of
this Phase 3 clinical trial
represents the successful culmination of these
efforts. is a biopharmaceutical company focused on
developing a
portfolio of internally discovered product candidates that utilize the body's
natural
nutrient transport mechanisms to improve the therapeutic benefits of
existing drugs. Countries vary
in how they deal with sleep disorders; in the U.
busting advisable
A community sponsored library.
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