DEERFIELD, Ill. and
OSAKA, Japan, Oct. 20, 2014 /PRNewswire/ -- Takeda
Pharmaceutical Company Limited ("Takeda"), its wholly-owned
subsidiary Takeda Pharmaceuticals U.S.A., Inc. and Orexigen®
Therapeutics, Inc. (Nasdaq: OREX) jointly announced today that
Contrave® (naltrexone HCI and bupropion HCI)
extended-release tablets are now available to patients by
prescription in pharmacies across the
United States. Contrave is approved by the U.S. Food and
Drug Administration (FDA) 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).
"We're excited that Contrave is now available and that we are
able to provide eligible patients with additional offerings," said
Douglas Cole, president, Takeda
Pharmaceuticals U.S.A., Inc.
"These offerings include the Scale Down program, a support program
for weight management, and Contrave Direct Save, which helps
eligible patients to get Contrave at the lowest cost available to
them, which can help to support a patient's complete approach to
weight management."
Eligible patients taking Contrave will have access to the Scale
Down program, which provides mobile weight management support with
a wireless scale that triggers daily personalized texts based on
weigh-ins. Scale Down, LLC is a company that is independent from
Takeda and is solely responsible for the program content. Takeda
will cover the membership costs associated with the Scale Down
program for all eligible patients during the offer period.
In addition, eligible patients will have access to Contrave
Direct Save, which provides the lowest cost available for both
commercially insured and cash-paying patients, with one-on-one
pharmacy support and the convenience of home delivery. When
patients use the available savings offer, Contrave Direct Save
provides progressive savings that begin on the third consecutive
month of treatment if patients do not miss a refill. In addition to
the Contrave Direct Save program, savings are also available to
eligible patients through a Pharmacy Savings Card for those who
prefer a retail pharmacy option.
Additional details about Contrave and the accompanying support
and savings programs are available at www.Contrave.com/FAQ.
"Today is an exciting day for our team at Orexigen and our
colleagues at Takeda as Contrave is now launched and available by
prescription in pharmacies across the country," said Michael Narachi, CEO of Orexigen. "We're proud
of our efforts working together to make this product available as a
treatment option for appropriate patients."
Takeda and Orexigen entered into a collaboration agreement on
September 1, 2010 for the development
and commercialization of Contrave in the
United States, Canada and
Mexico. Under the terms of the
agreement, Orexigen and Takeda agreed to work together on ongoing
development of Contrave. Orexigen agreed to lead pre-approval
development activities, and Takeda agreed to lead post-approval
development activities. Orexigen originally submitted the New Drug
Application (NDA) for Contrave to the FDA, which NDA was
transferred to Takeda by Orexigen after Contrave was approved by
the FDA on September 10, 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 accompanying Full Prescribing
Information, including Medication Guide, for
Contrave.
More information is also available at
www.ContraveHCP.com and 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. Scale Down is
a program designed and sold by Scale Down, LLC. Scale Down, LLC is
an independent company and not part of Takeda Pharmaceuticals
U.S.A., Inc. Takeda does not
control the content developed and presented by the Scale Down
program. All other trademarks are the property of their respective
owners.
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 Contrave in
Europe, with potential approval
later in 2014. Further information about the Company can be found
at www.orexigen.com.
About Takeda Pharmaceuticals U.S.A., Inc.
Based in Deerfield, Ill.,
Takeda Pharmaceuticals U.S.A.,
Inc. is a subsidiary of Takeda Pharmaceutical Company Limited, the
largest pharmaceutical company in Japan. TPUSA markets oral diabetes, CNS,
rheumatology and gastroenterology treatments. Its pipeline includes
compounds for metabolic and cardiovascular disease,
gastroenterology, neurology and other conditions. To learn more,
visit www.takeda.us.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda
is a research-based global company with its main focus on
pharmaceuticals. As the largest pharmaceutical company in
Japan and one of the global
leaders of the industry, Takeda is committed to strive towards
better health for people worldwide through leading innovation in
medicine. Additional information about Takeda is available through
its corporate website, www.takeda.com.
Forward-Looking Statements
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 Companies' current beliefs and expectations. These
forward-looking statements include statements regarding: the
availability of Takeda's additional offerings; and the potential
for Contrave to achieve commercial success in the obesity market.
Inclusion of forward‐looking statements should not be regarded as a
representation by either company 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 business, including, without limitation: Orexigen's
dependence on Takeda to carry out the commercial launch of
Contrave; competition in the obesity market, particularly from
existing therapies; the ability to obtain and maintain intellectual
property protection for Contrave; additional analysis of the
interim results of the LIGHT study or new data from the continuing
LIGHT study and the additional cardiovascular outcomes trial,
including safety-related data, may produce negative or inconclusive
results; 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 neither Takeda nor Orexigen undertake any
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 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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/takeda-and-orexigen-announce-availability-of-contrave-naltrexone-hci-and-bupropion-hci-extended-release-tablets-for-chronic-weight-management-in-obese-adults-871997028.html
SOURCE Takeda Pharmaceutical Company Limited