SAN DIEGO, Sept. 26, 2017 /PRNewswire/ -- Orexigen
Therapeutics, Inc. (Nasdaq: OREX) announced today the launch of the
next stage of "Brains Behind Weight Loss," the Company's national
direct-to-consumer advertising campaign for Contrave® (naltrexone
HCl/bupropion HCl extended release tablets). The campaign is
designed to demonstrate to patients how the brain plays an
important role in weight loss. Contrave is the number one
prescribed weight-loss brand and the DTC campaign spans across TV
and digital with a strong presence in social media. Contrave
is the first and only prescription pharmaceutical brand to have an
active presence on Instagram to reach patients searching for
weight-loss information.
Leveraging the start of the fall season, the DTC campaign will
run through mid-October. The campaign continues to focus on
empowering women, as more than 80 percent of patients being treated
are women and market research has demonstrated that women are more
likely to take action or talk to a doctor about their struggle with
weight loss.
The campaign also introduces Orexigen's Get Contrave Now
telemedicine and free home delivery platform, which is available
nationwide. By visiting GetContraveNow.com, patients have the
choice of finding a weight-loss specialist near them or talking to
a doctor online from the comfort of their home. Telemedicine
and free home delivery offer patients benefits such as convenience,
immediacy and privacy. The national roll-out of Get Contrave
Now follows a successful pilot program in California and Texas.
"Telemedicine is the future of healthcare, as evidenced by
groundbreaking programs launched by industry leaders such as Kaiser
Permanente, Johns Hopkins Medicine and the Cleveland Clinic," said
Dr. Thomas Cannell, EVP, Chief Operating Officer and President
of Global Commercial Products at Orexigen. "As a company that
is driven to help improve the health and lives of patients
struggling to lose weight, we believe our strategy leverages
telemedicine as a sustainable and powerful digital health trend
that provides high quality healthcare, with an Amazon-like ease and
speed."
"For many women, the fall, or 'back to school' season, is an
opportunity to reset their personal goals and get 'back to
routine.' We want to help patients and healthcare
professionals have engaging and motivating discussions about their
weight-loss struggle and treatment options," said Salma Jutt, Vice President of U.S. Marketing at
Orexigen. "There is still a social stigma affecting patients
who struggle with their weight and still a belief that weight
issues are due to lifestyle choices. Patients may not know
their brain plays a role in weight loss, so they don't talk openly
about their struggle and they may not seek treatment options, such
as adding Contrave to their diet and exercise regimen."
In the U.S., more than two in three adults are considered
overweight or struggling with obesity, and the prevalence of
patients who are overweight or struggling with obesity is rapidly
increasing.i In addition, only 2 percent of
eligible adults are treated with a prescription weight-loss
medication.
About Contrave
Contrave is a prescription-only, FDA-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 leading
to weight loss are not fully understood. Contrave contains
two medicines, bupropion, a relatively weak inhibitor of the
neuronal reuptake of dopamine and norepinephrine and naltrexone, an
opioid antagonist.
Contrave, approved by the FDA in September 2014, 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).
Orexigen is committed to helping eligible patients learn about
Contrave and recommends patients visit www.contrave.com for
additional information.
For more information and full prescribing information please
visit www.contrave.com.
Important Safety Information for CONTRAVE
(naltrexone HCl and bupropion HCl) 8 mg/90 mg
extended-release tablets
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). One of the ingredients in CONTRAVE, bupropion, is
the same ingredient in some other medicines used to treat
depression and to help people quit smoking.
Ask your doctor or healthcare professional if CONTRAVE is
right for you. 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
https://www.fda.gov/Safety/MedWatch/default.htm or call
1‑800‑FDA‑1088.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused
on the treatment of weight loss and obesity. The company's
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 Contrave / Mysimba to patients around the
world. As a patient-centric company, Orexigen continues to
focus not only on innovating medicine for the treatment of obesity,
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 success of
marketing and commercialization of Contrave in the United States, including Orexigen's
national direct-to-consumer advertising campaign and telemedicine
and free home delivery platform; and the potential growth of
Contrave sales.
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; the company's ability
to adequately inform consumers about Contrave; the company's
ability to successfully commercialize Contrave with a specialty
sales force in the United States;
the capabilities and performance of various third parties on which
it relies for a number of activities related to the manufacture,
development and commercialization of Contrave/Mysimba; the
estimates of the capacity of manufacturing and the company's
ability to secure additional manufacturing capabilities; the
company's ability to successfully complete the post-marketing
requirement studies for Contrave; the therapeutic and commercial
value of Contrave/Mysimba; competition in the global obesity
market, particularly from existing therapies; the company's failure
to successfully acquire, develop and market additional product
candidates or approved products; the company's ability to obtain
and maintain global intellectual property protection for Contrave
and Mysimba; the potential for a Delaware court to determine that one or more
of the company's patents is not valid or that Actavis' proposed
generic product is not infringing each of the patents at issue;
other legal or regulatory proceedings against Orexigen, as well as
potential reputational harm, as a result of misleading public
claims about Orexigen; the company's ability to maintain sufficient
capital to fund its operations for the foreseeable future; the
company's ability to satisfy covenants in the indentures for its
outstanding indebtedness, including one requirement that the
company generate consolidated net product sales of least
$100 million for fiscal 2017; the
company's ability to satisfy the applicable listing standards of
the NASDAQ Global Market; 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 we filed with the Securities and Exchange
Commission on August 9, 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 Contacts:
Jason Keyes
Chief Financial Officer
Orexigen Therapeutics, Inc.
+1-858-875-8600
jkeyes@orexigen.com
Erika Hackmann
Y&R PR (Media Contact for Orexigen)
+1-917-538-3375
erika.hackmann@yr.com
i CDC – National Health and Nutrition Examination
Survey 2013-2014
https://www.cdc.gov/nchs/data/hestat/obesity_adult_13_14/obesity_adult_13_14.pdf
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SOURCE Orexigen Therapeutics, Inc.