LA JOLLA, Calif., Oct. 31, 2014 /PRNewswire/ -- Orexigen
Therapeutics (NASDAQ: OREX) today announced three Contrave®
(naltrexone HCI and bupropion HCI) and two disease awareness
abstracts have been accepted for poster presentations at the
upcoming ObesityWeek meeting. This meeting will be held
November 2-7, 2014 in Boston at the Boston Convention and Exposition
Center.
Details on the presentation times are as follows:
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Date/Time:
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November 6, 2014,
12:00 – 1:30 PM
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Title:
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Food craving and
weight loss: an integrated analysis of the effects of
sustained-release naltrexone/bupropion (NB) on the cravings and
mood sub-scales of the Control of Eating Questionnaire (CoEQ)
(Poster abstract #T-2655-P)
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Presenter:
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M. Dalton
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Date/Time:
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November 6, 2014,
12:00 – 1:30 PM
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Title:
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Weight Loss with
sustained release naltrexone/bupropion (NB) as an adjunct to
intensive behavior modification: A subgroup analysis in African
American and white subjects. (Poster abstract
#T-2562-P)
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Presenter:
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C. Dybala
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Date/Time:
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November 6, 2014,
12:00 – 1:30 PM
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Title:
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Psychometric
properties of the Control of Eating Questionnaire for the
experience of food cravings: validation in overweight and obese
adults in an integrated analysis of Phase 3, randomized,
double-blind, placebo-controlled trials of sustained release
naltrexone/bupropion (Poster abstract #T-2654-P)
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Presenter:
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M. Dalton
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Date/Time:
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November 4, 2014,
11:30 AM – 1:00 PM
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Title:
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Validation of a new
obesity model to epidemiological and cost studies (Poster abstract
#T-2139-P)
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Presenter:
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T. Ward
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Date/Time:
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November 6, 2014,
12:00 – 1:30 PM
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Title:
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Characteristics of
patients potentially eligible for obesity pharmacotherapy in a
real-world setting in the United States (Poster abstract
#T-2661-P)
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Presenter:
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S. Zhang
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About Contrave
Contrave is a combination of naltrexone, an opioid antagonist,
and bupropion, a relatively weak inhibitor of the neuronal reuptake
of dopamine and norepinephrine. While the exact neurochemical
effects of Contrave leading to weight loss are not fully
understood, nonclinical studies suggest that naltrexone and
bupropion have effects on two separate areas of the brain involved
in the regulation of food intake: the hypothalamus (appetite
regulatory center) and the mesolimbic dopamine circuit (reward
system). Contrave received approval from the U.S. Food and Drug
Administration (FDA) as an adjunct to a reduced hyphen calorie diet
and increased physical activity for chronic weight management in
adults with an initial body mass index (BMI) of 30 kg/m2
or greater (obese), or 27 kg/m2 or greater (overweight)
in the presence of at least one weight-related comorbid condition
in September 2014.
Important Safety Information
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC
REACTIONS
SUICIDALITY AND ANTIDEPRESSANT DRUGS
CONTRAVE is not approved for use in the treatment of major
depressive disorder or other psychiatric disorders. CONTRAVE
contains bupropion, the same active ingredient as some other
antidepressant medications (including, but not limited to,
WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL and APLENZIN).
Antidepressants increased the risk of suicidal thoughts and
behavior in children, adolescents, and young adults in short-term
trials. These trials did not show an increase in the risk of
suicidal thoughts and behavior with antidepressant use in subjects
over age 24; there was a reduction in risk with antidepressant use
in subjects aged 65 and older. In patients of all ages who are
started on CONTRAVE, monitor closely for worsening, and for the
emergence of suicidal thoughts and behaviors. Advise families and
caregivers of the need for close observation and communication with
the prescriber. CONTRAVE is not approved for use in pediatric
patients.
NEUROPSYCHIATRIC REACTIONS IN PATIENTS TAKING BUPROPION FOR
SMOKING CESSATION
Serious neuropsychiatric reactions
have occurred in patients taking bupropion for smoking cessation.
The majority of these reactions occurred during bupropion
treatment, but some occurred in the context of discontinuing
treatment. In many cases, a causal relationship to bupropion
treatment is not certain, because depressed mood may be a symptom
of nicotine withdrawal. However, some of the cases occurred in
patients taking bupropion who continued to smoke. Although CONTRAVE
is not approved for smoking cessation, observe all patients for
neuropsychiatric reactions. Instruct the patient to contact a
healthcare provider if such reactions occur.
Contraindications: CONTRAVE is contraindicated in
patients with uncontrolled hypertension, seizure disorder, or
current or prior diagnosis of anorexia nervosa or bulimia; in
patients undergoing abrupt discontinuation of alcohol,
benzodiazepines, barbiturates, and antiepileptic drugs; with use of
other bupropion-containing products; for use with chronic opioids
or opiate agonists (eg, methadone) or partial agonists (eg,
buprenorphine) or acute opiate withdrawal; during/within 14 days
following treatment with monoamine oxidase inhibitors (MAOIs); in
patients with known allergy to any other component of
CONTRAVE—anaphylactoid/anaphylactic reactions and Stevens-Johnson
syndrome have been reported; in pregnancy.
Warnings and Precautions
Suicidal Behavior and
Ideation: All patients being treated with antidepressants for any
indication should be monitored appropriately and observed closely
for clinical worsening, suicidality, and unusual changes in
behavior, especially during the initial few months of a course of
drug therapy or at times of dose changes, either increases or
decreases. Consider changing the therapeutic regimen or
discontinuing in patients whose depression is persistently worse,
or who are experiencing emergent suicidality or symptoms of
anxiety, agitation, panic attacks, insomnia, irritability,
hostility, aggressiveness, impulsivity, akathisia (psychomotor
restlessness), hypomania, or mania, especially if these symptoms
are severe, abrupt in onset, or were not part of the patient's
presenting symptoms. Alert families and caregivers of patients
being treated with antidepressants about the need to monitor
patients for the emergence of above mentioned symptoms, as well as
the emergence of suicidality, daily and to report such symptoms
immediately. Prescriptions for CONTRAVE should be written for the
smallest quantity of tablets consistent with good patient
management in order to reduce the risk of overdose.
Neuropsychiatric Symptoms and Suicide Risk in Smoking
Cessation Treatment: CONTRAVE is not approved for smoking
cessation treatment, but serious neuropsychiatric symptoms have
been reported in patients taking bupropion for smoking cessation,
including changes in mood (including depression and mania),
psychosis, hallucinations, paranoia, delusions, homicidal ideation,
hostility, agitation, aggression, anxiety and panic, as well as
suicidal ideation, suicide attempt, and completed suicide. Observe
patients for the occurrence of neuropsychiatric reactions. Instruct
patients to contact a healthcare professional if such reactions
occur.
Seizures: CONTRAVE can cause seizures. The risk of
seizure is dose-related. Discontinue treatment and do not restart
CONTRAVE in patients who experience a seizure. Use caution and
consider the risk when prescribing CONTRAVE to patients with
predisposing factors, clinical situations, and concomitant
medications that may lower seizure threshold. Risk of seizure may
be minimized by adhering to the recommended dosing schedule and
avoiding co-administration with a high-fat meal.
Patients Receiving Opioid Analgesics: CONTRAVE should not
be administered to patients receiving chronic opioids. Patients may
be vulnerable to opioid overdose and/or precipitated opioid
withdrawal.
Increase in Blood Pressure (BP) and Heart Rate (HR):
CONTRAVE can cause an increase in systolic BP, diastolic BP, and/or
resting HR. Monitor BP and HR especially in patients with cardiac
or cerebrovascular disease and/or with controlled hypertension.
Allergic Reactions: Anaphylactoid/anaphylactic reactions
and symptoms suggestive of delayed hypersensitivity have been
reported in clinical trials with bupropion, as well as rare
spontaneous reports of erythema multiforme, Stevens-Johnson
syndrome, and anaphylactic shock.
Hepatotoxicity: Cases of hepatitis, clinically
significant liver dysfunction, and transient asymptomatic hepatic
transaminase elevations have been observed with naltrexone
exposure. Use of CONTRAVE should be discontinued in the event of
symptoms/signs of acute hepatitis.
Activation of Mania: Prior to initiating CONTRAVE, screen
patients for history of bipolar disorder and the presence of risk
factors for bipolar disorder (eg, family history of bipolar
disorder, suicide, or depression).
Angle-Closure Glaucoma: The pupillary dilation that
occurs following use of many antidepressant drugs, including
bupropion, a component of CONTRAVE, may trigger an angle-closure
attack in a patient with anatomically narrow angles who does not
have a patent iridectomy.
Use of Antidiabetic Medications: Weight loss may increase
the risk of hypoglycemia in patients with type 2 diabetes mellitus
treated with insulin and/or insulin secretagogues (eg,
sulfonylureas). Monitor blood glucose levels.
Adverse Reactions: Most common adverse reactions (>5%)
include: nausea (32.5%), constipation (19.2%), headache (17.6%),
vomiting (10.7%), dizziness (9.9%), insomnia (9.2%), dry mouth
(8.1%), and diarrhea (7.1%).
Drug Interactions: Increased risk of hypertensive
reactions can occur when CONTRAVE is used concomitantly with MAOIs.
Use caution and consider dose reduction of drugs metabolized by
CYP2D6 when using with CONTRAVE. Avoid concomitant use with CYP2B6
inducers. Reduce CONTRAVE dose when taken with CYP2B6 inhibitors.
Dose CONTRAVE with caution when used with drugs that lower seizure
threshold. Use caution and monitor for CNS toxicity when using
CONTRAVE concomitantly with dopaminergic drugs (levodopa and
amantadine). CONTRAVE can cause false positive urine test results
for amphetamines.
Indication
CONTRAVE is indicated as an adjunct to a
reduced-calorie diet and increased physical activity for chronic
weight management in adults with an initial body mass index (BMI)
of:
- 30 kg/m2 or greater (obese) or
- 27 kg/m2 or greater (overweight) in the presence of
at least one weight-related comorbid condition (eg, hypertension,
type 2 diabetes mellitus, or dyslipidemia)
Limitations of Use
The effect of CONTRAVE on cardiovascular morbidity and mortality
has not been established. The safety and effectiveness of CONTRAVE
in combination with other products intended for weight loss,
including prescription drugs, over-the-counter drugs, and herbal
preparations, have not been established.
Please see full Prescribing Information,
including Medication Guide, for
Contrave.
More information is available at http://www.contravehcp.com/ and
http://www.contrave.com/.
Contrave® is a trademark of Orexigen Therapeutics, Inc.
registered with the U.S. Patent and Trademark Office and used under
license by Takeda Pharmaceuticals America, Inc.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company
focused on the treatment of obesity. Orexigen developed Contrave®
(naltrexone HCI and bupropion HCI extended-release), which is
approved in the United States.
Orexigen's strategy for Contrave is to pursue marketing
authorizations worldwide and pharmaceutical partnerships for global
commercialization. Orexigen's partner for North America, Takeda Pharmaceuticals, will
commercialize Contrave in the United
States, Canada and
Mexico. Orexigen has submitted an
application for marketing authorization for NB32 (naltrexone HCI
and bupropion HCI extended-release) in Europe, with an opinion from the European
Medicines Agency's Committee for Medicinal Products for Human Use
(CHMP) expected in December 2014.
Further information about the Company can be found at
http://www.orexigen.com/.
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," "should,"
"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 timing of an opinion for the NB32 MAA by
the CHMP by year end; the success of a U.S. primary care launch of
Contrave; the Company's strategy to pursue marketing authorizations
worldwide; and the potential to obtain partner(s) to commercialize
Contrave in certain territories outside of North America. 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 materially from those expressed or
implied in this release due to the risk and uncertainties inherent
in the Orexigen business, including, without limitation: the
possibility that public disclosure of the results of the interim
analysis of the Light Study would later be deemed to jeopardize the
integrity of ongoing cardiovascular outcomes trials resulting in
the requirement to conduct additional, costly studies; additional
analysis of the interim results or new data from the continuing
Light Study, including safety-related data, may produce negative or
inconclusive results, or may be inconsistent with the conclusion
that the interim analysis was successful; the potential that the
interim analysis may not be predictive of future results in the
Light Study or another cardiovascular outcomes trial; the
possibility that the CHMP determines to not approve Contrave; the
potential for early termination of Orexigen's North American
collaboration agreement with Takeda; the possibility that Orexigen
is unable to find a partner for Contrave in territories outside of
North America, the final results
of the Light Study or another cardiovascular outcomes trial may not
support continued approval of Contrave; the therapeutic and
commercial value of Contrave; and other risks described in
Orexigen'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. Further
information regarding these and other risks is included under the
heading "Risk Factors" in Orexigen's Quarterly Report on Form 10-Q
filed with the Securities and Exchange Commission on August 8, 2014 and its other reports, which are
available from the SEC's website (www.sec.gov) and on Orexigen's
website (www.orexigen.com) under the heading "Investor Relations."
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.
Investor
Contact
|
McDavid
Stilwell
|
VP, Corporate
Communications and Business Development
|
(858)
875-8629
|
|
Media
Contact
|
David
Walsey
|
BrewLife,
Inc.
|
(858)
617-0772
|
SOURCE Orexigen Therapeutics, Inc.