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Orexigen(R) Therapeutics Presents Data On Its Proprietary Formulation Of Naltrexone Sustained Release (SR) Used In Contrave(R)
Orexigen Therapeutics, Inc.
(Nasdaq: OREX), a biopharmaceutical company focused on the treatment of
obesity and other central nervous system-related disorders, presented
data showing the investigational drug, Contrave(R) (naltrexone SR /
bupropion SR), successfully achieved key objectives (lowered naltrexone
Cmax, increased Tmax, comparable AUC) in two Phase 1 clinical trials. In
addition, preliminary analysis of blinded data from nearly 4,000 patients
participating in a series of four ongoing Phase 3 trials supports that the
naltrexone SR formulation improvements are associated with tolerability
advantages. Results from this series of investigations have been selected
for presentation at The Obesity Society Annual Scientific Meeting.
"Contrave contains a sustained release formulation of naltrexone which
we believe will improve tolerability, enhance patient compliance and
improve weight loss outcomes in patients with obesity, a disorder which
afflicts more than 75 million Americans," said Gary Tollefson, M.D., Ph.D.,
Orexigen President and CEO. "The Phase 3 formulation of naltrexone in an
oral sustained release form may be a key factor in allowing more patients
to achieve the potential benefits associated with greater weight loss."
About the Clinical Trials
The primary objective of the naltrexone sustained release (SR)
development program was to improve tolerability by slowing the rate at
which naltrexone dissolves, slowing its entry into the bloodstream (Tmax)
and reducing the peak concentration it achieves in the blood (Cmax). A
series of studies was conducted to validate this approach.
-- Relative bioavailability was assessed in 40 patients randomized to
naltrexone SR 40mg or naltrexone immediate release (IR) 36mg in a single
dose, crossover PK assessment. Analyses revealed that, on a dose-normalized
basis, naltrexone SR was associated with a 43.3% lower peak concentration
but a comparable exposure or area-under-the-curve (AUC) to the IR
formulation. The Tmax or time to peak concentration was approximately 36
minutes slower for naltrexone SR compared to naltrexone IR.
-- Preliminary evidence for improved tolerability with naltrexone SR
came from a trial utilizing a multiple dose, parallel design in 60 healthy
volunteers randomized to either naltrexone SR 37.5mg / bupropion SR 270mg
or naltrexone IR 36mg / bupropion SR 270mg. Patients were treated for up to
14 days. Naltrexone SR / bupropion SR patients spontaneously reported fewer
GI adverse events (10.3% vs. 16.7%) or CNS adverse events (10.3% vs.
23.3%). GI event severity was also subjectively lowered with the naltrexone
SR formulation.
-- In a preliminary effort to evaluate apparent improvements in
tolerability associated with naltrexone SR, pooled 24 week data from the
Phase 2 NB-201 Contrave trial (N=212) with naltrexone IR was compared with
the 24 week blinded data from a series of four Phase 3 Contrave trials
(N=3,943 evaluable patients), all employing naltrexone SR. These Phase 3
trials all have varying designs, doses and patient populations; the
discontinuation due to adverse event rates associated with them ranged from
13.8% to 22.8%. However, compared to the Phase 2 trial experience, lower
rates of nausea were evident across the four pooled Phase 3 trials. In
study NB-301 (N=1,689 evaluable patients), the trial with dosing most
similar to the Phase 2 NB-201 trial, nausea, headache, or dizziness were
all less frequent than in the prior Phase 2 trial, as was the overall rate
of early discontinuation due to any adverse event (13.8% versus 16.0%).
-- Across the Contrave Phase 3 trial experience to date, only 7.6% of
all reported adverse events led to an early discontinuation from the
trials.
In summary, naltrexone SR met its primary objectives by providing a
lower peak plasma concentration (Cmax) than the legacy IR formulation while
retaining a similar total plasma exposure (AUC). This held true both for
the parent molecule (naltrexone) and its principal active metabolite
(6-beta-naltrexol). In a Phase I pilot study, improved tolerability was
suggested amongst those who received naltrexone SR / bupropion SR than
those receiving the prior Phase 2 formulation containing naltrexone IR.
Finally, in a blinded, pooled analysis of preliminary Phase 3 data, results
suggest that naltrexone SR / bupropion SR may be associated with decreased
rates of treatment-emergent nausea, headache, dizziness, or discontinuation
due to an adverse event.
About Orexigen(R) Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on
the treatment of obesity and other central nervous system-related
disorders. The Company's lead combination product candidates targeted for
obesity are Contrave(R), which is in Phase 3 clinical trials, and
Empatic(TM), which is in the later stages of Phase 2 clinical development.
Each product candidate is designed to act on a specific group of neurons in
the central nervous system with the goal of achieving appetite suppression
and sustained weight loss. Beyond obesity, Orexigen is developing drug
combinations for use in schizophrenia and obsessive-compulsive disorder.
Further information about the company can be found at
http://www.Orexigen.com.
About Contrave(R)
Contrave is an investigational weight loss medication with a mechanism
of action that works at two sites within the central nervous system. The
first is a hypothalamic site that controls the balance of food intake and
metabolism. We believe that Contrave is possibly the first treatment for
obesity to address a second site, the reward system in the brain that
controls food preference and food cravings. In clinical trials, Contrave
has initiated and sustained significant weight loss over one year of
treatment (approximately 8.0% - 10.7% in patients completing 48 weeks of
therapy) by reducing appetite, increasing metabolism [0]and allowing the
body to continue losing weight by offsetting its natural tendency to fight
back and slow down the weight loss process. We expect to receive data from
the first of our Contrave Phase 3 trials in January of 2009 and the
remaining three trials by mid next year.
About Empatic(TM)
Empatic is a fixed dose combination of bupropion SR with our
proprietary sustained release formulation of zonisamide. Research indicates
that zonisamide inhibits AgRP, a system associated with increasing appetite
while bupropion increases metabolism. Based on the strength of these
results and the unique Empatic mechanism of action, the Company selected
this product combination to complement our Contrave clinical development
program.
Forward Looking Statements
Orexigen cautions you that statements included in this press release
that are not a description of historical facts are forward-looking
statements. Words such as "believes," "anticipates," "plans," "expects,"
"indicates," "will," "intends," "potential," "suggests," "assuming,"
"designed" and similar expressions are intended to identify forward-looking
statements. These statements are based on the Company's current beliefs and
expectations. These forward-looking statements include statements regarding
the enrollment, timing, execution and completion of clinical trials of its
product candidates, the timing of an NDA submission for Contrave, the
potential to obtain regulatory approval for, and effectively treat obesity
with, Contrave and Empatic, and the potential for naltrexone SR to improve
tolerability. The inclusion of forward-looking statements should not be
regarded as a representation by Orexigen that any of its plans will be
achieved. Actual results may differ from those set forth in this release
due to the risk and uncertainties inherent in the Orexigen business,
including, without limitation: the progress and timing of the Company's
clinical trials; the potential that earlier clinical trials may not be
predictive of future results; the ability for Contrave or Empatic to
receive regulatory approval on a timely basis or at all; the potential for
adverse safety findings relating to Empatic or Contrave to delay or prevent
regulatory approval or commercialization, or result in product liability
claims; the ability of Orexigen and its licensors to obtain, maintain and
successfully enforce adequate patent and other intellectual property
protection of its product candidates; and other risks described in the
Company's filings with the Securities and Exchange Commission. You are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date hereof, and Orexigen undertakes no
obligation to revise or update this news release to reflect events or
circumstances after the date hereof. All forward-looking statements are
qualified in their entirety by this cautionary statement. This caution is
made under the safe harbor provisions of Section 21E of the Private
Securities Litigation Reform Act of 1995.
Orexigen Therapeutics, Inc.
http://www.Orexigen.com
View drug information on Naltrexone Hydrochloride Tablets.
Orexigen (R) therapeutics prezintã date cu privire la formularea de proprietate Naltrexone susþinut de lansare (SR) folosite în Contrave (R) - Orexigen(R) Therapeutics Presents Data On Its Proprietary Formulation Of Naltrexone Sustained Release (SR) Used In Contrave(R) - articole medicale engleza - startsanatate