SAN DIEGO, May 16, 2017 /PRNewswire/ -- Orexigen
Therapeutics, Inc. (NASDAQ: OREX) announced today that the company
will present two oral presentations on naltrexone HCl / bupropion
HCl, marketed as Contrave® in the United
States and Mysimba® in the European Union, at the
24th European Congress on Obesity (ECO) in Porto, Portugal on May
17 – 20, 2017.
The oral presentations are scheduled during the Pharmacotherapy
session on Friday, May 19, 2017:
- Effect on body weight of naltrexone/bupropion in overweight and
obese participants with cardiovascular risk factors in a large
randomized double-blind study
-
- Authors: A. Halseth; K. Shan; K. Gilder; L. Acevedo; J.
Buse
- Naltrexone/bupropion is well tolerated and had no effect on
serious adverse events in participants receiving antidepressant
medication, including SSRIs, in a large randomized double-blind
study
-
- Authors: A. Halseth; K. Gilder; K. Shan; L. Acevedo; S.
Smith
Orexigen will also sponsor a satellite symposium, "Integrating
Pharmacotherapy into Obesity Management" on Thursday, May 18, 2017 to discuss the evolving
clinical understanding of obesity and the brain as well as the role
of pharmacotherapy in the management of the disease. The
following presenters will also share clinical trial evidence and
practical experience with naltrexone HCl / bupropion HCl:
- Prof. Mike Lean, MA, MB, BChir, FRCP, FRCPS, University of Glasgow School of Medicine, Dentistry
and Nursing
- Prof. Felipe F. Casanueva, MD,
PhD, Head, Dept. of Endocrinology and Nutrition, Complejo
Hospitalario Universitario de Santiago
- Deborah Bade Horn, DO, MPH,
MFOMA, President, Obesity Medicine Association
"We look forward to a meaningful discussion at ECO and to
presenting additional clinical data to support Mysimba as a
prescription treatment option for adults who are struggling with
obesity or overweight with related health conditions," said
Peter Flynn, Ph.D., Senior Vice
President, Global Head of Development, Regulatory Affairs and
Safety at Orexigen. "With global obesity rates continuing to
rise, it is imperative that we maintain an active dialogue with
physicians around effective treatment approaches for patients
struggling to lose weight."
Orexigen is committed to leveraging its extensive alliance
management capabilities to make Contrave/Mysimba available to
patients who struggle to lose weight around the world. The
company has entered into strategic partnerships covering 44
countries outside the U.S.
About Contrave and Mysimba
Contrave, marketed as Mysimba in the European Union, is a
prescription-only, FDA- and EMA-approved weight-loss medication
believed to work on two areas of the brain—the hunger center and
the reward system—to reduce hunger and help control cravings.
The exact neurochemical effects of Contrave/Mysimba leading
to weight loss are not fully understood. Contrave/Mysimba is
uniquely formulated with a proprietary combination of naltrexone
and bupropion. Independently, naltrexone and bupropion have
been used clinically for over 30 years. The individual
components are not approved for weight loss and Contrave/Mysimba is
not approved to treat depression or other mental illnesses, alcohol
or opioid dependency, or to help people quit smoking.
Naltrexone HCI/Bupropion HCI is indicated for use 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 (e.g., hypertension, type 2 diabetes mellitus or
dyslipidemia). Contrave was approved by the FDA in
September 2014, and Mysimba was
approved by the EMA in March
2015.
Orexigen is committed to helping eligible patients learn about
Contrave and recommend patients in the U.S. visit www.contrave.com
for additional information. For full U.S. prescribing
information please visit www.contrave.com.
Important Safety Information for CONTRAVE and MYSIMBA
One of the ingredients in CONTRAVE, bupropion, may increase
the risk of suicidal thinking in children, adolescents, and young
adults. CONTRAVE patients should be monitored for suicidal thoughts
and behaviors. In patients taking bupropion for smoking
cessation, serious neuropsychiatric adverse events have been
reported. CONTRAVE is not approved for use in children
under the age of 18.
Stop taking CONTRAVE and call a healthcare provider right
away if you have any of the following symptoms, especially if they
are new, worse, or worry you: thoughts about suicide or dying;
attempts to commit suicide; depression; anxiety; feeling agitated
or restless; panic attacks; trouble sleeping (insomnia);
irritability; aggression, anger, or violence; acting on dangerous
impulses; an extreme increase in activity and talking (mania);
other unusual changes in behavior or mood.
Do not take CONTRAVE if you have uncontrolled high blood
pressure; have or have had seizures; use other medicines that
contain bupropion such as WELLBUTRIN, APLENZIN or ZYBAN; have or
have had an eating disorder; are dependent on opioid pain medicines
or use medicines to help stop taking opioids such as methadone or
buprenorphine, or are in opiate withdrawal; drink a lot of alcohol
and abruptly stop drinking; are allergic to any of the ingredients
in CONTRAVE; or are pregnant or planning to become pregnant.
Before taking CONTRAVE, tell your healthcare provider about
all the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements.
Do not take any other medicines while you are taking CONTRAVE
unless your healthcare provider says it is okay.
Tell your healthcare provider about all of your medical
conditions including if you have: depression or other mental
illnesses; attempted suicide; seizures; head injury; tumor or
infection of brain or spine; low blood sugar or low sodium; liver
or kidney problems; high blood pressure; heart attack, heart
problems, or stroke; eating disorder; drinking a lot of alcohol;
prescription medicine or street drug abuse; are 65 or older;
diabetes; pregnant; or breastfeeding.
CONTRAVE may cause serious side effects, including:
Seizures. There is a risk of having a seizure when you
take CONTRAVE. If you have a seizure, stop taking CONTRAVE, tell
your healthcare provider right
away.
Risk of opioid overdose. Do not take large amounts of
opioids, including opioid-containing medicines, such as heroin or
prescription pain pills, to try to overcome the opioid-blocking
effects of naltrexone.
Sudden opioid withdrawal. Do not use any type of opioid
for at least 7 to 10 days before starting CONTRAVE.
Severe allergic reactions. Stop taking CONTRAVE and
get medical help immediately if you have any signs and symptoms of
severe allergic reactions: rash, itching, hives, fever, swollen
lymph glands, painful sores in your mouth or around your eyes,
swelling of your lips or tongue, chest pain, or
trouble breathing.
Increases in blood pressure or heart rate.
Liver damage or hepatitis. Stop taking CONTRAVE if
you have any symptoms of liver problems: stomach area pain lasting
more than a few days, dark urine, yellowing of the whites of your
eyes, or tiredness.
Manic episodes.
Visual problems (angle-closure glaucoma). Signs and
symptoms may include: eye pain, changes in vision, swelling or
redness in or around the eye.
Increased risk of low blood sugar (hypoglycemia) in people
with type 2 diabetes mellitus who also take medicines to treat
their diabetes (such as insulin or sulfonylureas).
The most common side effects of CONTRAVE include nausea,
constipation, headache, vomiting, dizziness, trouble sleeping, dry
mouth, and diarrhea.
These are not all the possible side effects of CONTRAVE. Tell
your healthcare provider about any side effect that bothers you or
does not go away.
Use of CONTRAVE
CONTRAVE is a prescription weight-loss medicine that may help
some adults with a body mass index (BMI) of
30 kg/m2 or greater (obese), or adults with a BMI
of 27 kg/m2 or greater (overweight) with at least
one weight-related medical problem such as high blood pressure,
high cholesterol, or type 2 diabetes, lose weight and keep the
weight off.
- CONTRAVE should be used with a reduced-calorie diet and
increased physical activity
- It is not known if CONTRAVE changes your risk of heart problems
or stroke or of death due to heart problems or stroke
- It is not known if CONTRAVE is safe and effective when taken
with other prescription, over-the-counter, or herbal weight-loss
products
CONTRAVE is not approved to treat depression or other mental
illnesses, or to help people quit smoking (smoking cessation).
Please see Full Prescribing Information, including
Medication Guide, for CONTRAVE.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or
call 1‑800‑FDA‑1088.
Indication and Usage of MYSIMBA in the European
Union
MYSIMBA is indicated, as an adjunct to a reduced-calorie diet
and increased physical activity, for the management of weight in
adult patients (≥18 years) with an initial Body Mass Index (BMI)
of
- ≥ 30 kg/m2 (obese), or
- ≥ 27 kg/m2 to < 30
kg/m2 (overweight) in the presence of one or more
weight-related co‑morbidities (e.g., type 2 diabetes,
dyslipidaemia, or controlled hypertension)
Treatment with MYSIMBA should be discontinued after 16 weeks if
patients have not lost at least 5% of their initial body
weight.
Please see Summary of Product Characteristics and
more information about MYSIMBA for EU patients available
at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003687/human_med_001845.jsp&mid=WC0b01ac058001d124
Mysimba™ and Contrave ® are trademarks of Orexigen
Therapeutics, Inc.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company
focused on the treatment of weight loss and obesity. Our
mission is to help improve the health and lives of patients
struggling to lose weight. Orexigen's first product, Contrave®
(naltrexone HCl and bupropion HCl extended release), was approved
in the U.S. in September 2014.
In the European Union, the medicine has been approved under
the brand name Mysimba® (naltrexone HCl/ bupropion HCl prolonged
release). Millions around the globe continue to face
challenges of weight loss. Orexigen is undertaking a range of
development and commercialization activities, both on its own and
with strategic partners, to bring solutions to patients around the
world. As a patient-centric company, Orexigen continues to
focus not only on innovating medicine for the treatment of obesity,
pain management and medication-assisted therapy for drug addiction,
but to also offer unique resources and healthcare delivery options
to improve the patient experience. Further information about
Orexigen can be found at 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 potential for Mysimba
to improve the quality of life for patients who are overweight or
struggle with obesity; the potential to grow the availability of
Mysimba with commercial launches in 2017; the potential for the
growth of the obesity problem; and the expectation to progress with
our ex-U.S. commercial alliances in 2017. 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
potential that the marketing and commercialization of
Contrave/Mysimba will not be successful, particularly, with respect
to Contrave, in the U.S. following the launch of the
patient-focused marketing campaign; the Company's ability to obtain
and maintain partnerships and marketing authorization globally; our
ability to adequately inform consumers about Contrave; our ability
to successfully commercialize Contrave with a specialty sales force
in the United States; our ability
to successfully complete the post-marketing requirement studies for
Contrave; the capabilities and performance of various third parties
on which we rely for a number of activities related to the
manufacture, development and commercialization of Contrave/Mysimba;
the therapeutic and commercial value of Contrave/Mysimba;
competition in the global obesity market, particularly from
existing and generic therapies; the Company's failure to
successfully acquire, develop and market additional product
candidates or approved products; the estimates of the capacity of
manufacturing and the company's ability to secure additional
manufacturing capabilities; our ability to obtain and maintain
global intellectual property protection for Contrave and Mysimba;
legal or regulatory proceedings against Orexigen, as well as
potential reputational harm, as a result of misleading public
claims about Orexigen; our ability to maintain sufficient capital
to fund our operations for the foreseeable future; the potential
for a Delaware court to determine
that one or more of the patents are not valid or that Actavis'
proposed generic product is not infringing each of the patents at
issue; 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 will be included under the heading
"Risk Factors" in Orexigen's Quarterly Report on Form 10-Q which
Orexigen filed with the Securities and Exchange Commission on
May 11, 2017 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
"Investors." 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 Investor Contact:
Jason Keyes, Chief Financial
Officer
+1-858- 875-8600
ir@orexigen.com
Orexigen Media Contact:
Erika Hackmann
Y&R
+1-917-538-3375
erika.hackmann@yr.com
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SOURCE Orexigen Therapeutics, Inc.