HOLLYWOOD, Fla., June 17, 2014 /PRNewswire/ -- Takeda
Pharmaceuticals Company Limited (Takeda) and H. Lundbeck A/S
(Lundbeck) today announced that the companies will present results
about sexual functioning from a head-to-head study of
Brintellix® (vortioxetine) vs. escitalopram in patients
with well treated major depressive disorder (MDD) experiencing
treatment-emergent sexual dysfunction (TESD). The data, accepted as
a late-breaker, will be shared in a poster presentation (#41) today
at 11:15 a.m. EDT.
In the study, 447 patients with recent major depressive episodes
who had responded to SSRI monotherapy but were experiencing TESD
were discontinued on their initial treatment and then randomized to
Brintellix 10 mg/day or escitalopram 10 mg/day (10 mg for week one
and 20 mg for week two of treatment) for eight weeks. The dose of
Brintellix or escitalopram could be adjusted after week two, four,
or six, as judged by the investigator. The primary endpoint was
change from baseline to week 8 in the Changes in Sexual Functioning
Questionnaire Short-Form (CSFQ-14) total score using mixed-effects
model repeated measures approach (MMRM).
"In this study, patients who were well treated for MDD but
experienced treatment-emergent sexual dysfunction showed
significant improvement in sexual function with Brintellix vs.
escitalopram," said Anita H.
Clayton, M.D., University of
Virginia School of Medicine and study investigator. "It is
helpful to have a study specifically looking at this side effect
that provides more information on the topic of TESD."
The results demonstrated that patients treated with Brintellix
(n=169) experienced a statistically significant improvement, with a
mean treatment difference of 2.2 points (95% CI: 0.48–4.02) in the
CSFQ-14 total score after eight weeks of treatment (P=0.013;
MMRM) compared to escitalopram (n=179). The CSFQ-14 is a clinical
and research instrument identifying five scales of sexual
functioning and yields scores for three scales corresponding to the
phases of the sexual response cycle.1 Numerically more
Brintellix-treated patients were responders (change from baseline
in CSFQ-14 total score >3; OR=1.51; P=0.06), as compared with
escitalopram. Numerically similar responses on the
Montgomery-Åsberg Depression Rating Scale (MADRS) total score were
observed between the two groups at the end of week eight. In this
study, common adverse events for Brintellix were nausea, headache,
and dizziness.
These findings build on the global clinical trial program for
Brintellix. The comprehensive clinical trial program evaluating the
safety and efficacy of Brintellix was comprised of seven positive
pivotal studies, including six 6-8 week short-term studies and one
24-64 week long-term maintenance study that demonstrated
statistically significant improvements in overall symptoms of
depression in adults with MDD.
The FDA approved Brintellix on September
30, 2013 for the treatment of MDD in adults.
Patients can visit www.Brintellix.com to sign up for additional
information about this new treatment option.
About Brintellix (vortioxetine)
The mechanism of the
antidepressant effect of Brintellix is not fully understood. It is
an inhibitor of serotonin (5-HT) reuptake and that is thought to be
a mechanism of its action. It is also an agonist at 5-HT1A
receptors, a partial agonist at 5-HT1B receptors and an antagonist
at 5-HT3, 5-HT1D and 5-HT7 receptors. The contribution of each of
these activities to Brintellix's antidepressant effect has not been
established. It is considered to be the first and only compound
with this combination of pharmacodynamic activity. The clinical
relevance of this is unknown.
Brintellix was discovered by Lundbeck researchers in
Copenhagen, Denmark. The clinical
trial program in the U.S. was conducted jointly by Lundbeck and
Takeda, and Takeda holds the new drug application for the U.S.
market. Brintellix is a trademark of H. Lundbeck A/S and is used
under license by Takeda Pharmaceuticals America, Inc.
The World Health Organization has issued an Anatomical
Therapeutic Chemical (ATC) code for Brintellix that places it in
the category of "Other" antidepressants.
The most commonly observed adverse events in MDD patients
treated with Brintellix in 6-8 week placebo-controlled studies
(incidence greater than or equal to 5 percent and at least twice
the rate of placebo) were nausea, constipation and vomiting.
Overall, 5 to 8 percent of the patients who received Brintellix 5
to 20 mg/day in short-term trials discontinued treatment due to an
adverse reaction, the most common being nausea, compared with 4
percent of placebo-treated patients in these studies. Brintellix
and other antidepressants may cause serious side effects. See
Important Safety Information below.
In clinical studies, Brintellix had no significant effect on
body weight as measured by the mean change from baseline in 6-8
week placebo-controlled studies. In the 6-month, double-blind,
placebo-controlled phase of a long-term study in patients who had
responded to Brintellix during the initial 12-week, open-label
phase, there was no significant effect on body weight between
Brintellix and placebo-treated patients. Brintellix has not been
associated with any clinically significant effects on vital signs,
including systolic and diastolic blood pressure and heart rate, as
measured in placebo-controlled studies.
The recommended starting dose of Brintellix is 10 mg once daily
without regard to meals. The dose should then be increased to 20
mg/day, as tolerated, because higher doses demonstrated better
treatment effects in trials conducted in the U.S. A dose decrease
down to 5 mg/day may be considered for patients who do not tolerate
higher doses. The available doses provide important flexibility for
physicians to help address the variability of patient needs.
Brintellix is available as 5 mg, 10 mg and 20 mg tablets.
IMPORTANT SAFETY INFORMATION
Suicidal Thoughts or Actions
Antidepressants may
increase suicidal thoughts or actions in some children, teens or
young adults within the first few months of treatment or when the
dose is changed. Depression or other serious mental illnesses are
the most important causes of suicidal thoughts or actions. People
who have (or have a family history of) bipolar illness, or suicidal
thoughts or actions may have a particularly high risk. Pay close
attention to any changes, especially sudden changes in mood,
behavior, thoughts or feelings. Call your healthcare provider right
away if symptoms such as anxiety, irritability, impulsivity,
trouble sleeping, aggressive behavior or suicidal thoughts are new,
worse or worry you. BRINTELLIX has not been evaluated for use in
patients under 18.
Do not take BRINTELLIX if you:
- Are allergic to vortioxetine or any of the ingredients in
BRINTELLIX
- Take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare
provider or pharmacist if you are not sure if you take an MAOI,
including the antibiotic linezolid; do not take an MAOI within 21
days of stopping BRINTELLIX; do not start BRINTELLIX if you stopped
taking an MAOI in the last 14 days
BRINTELLIX may cause serious side effects
including:
Serotonin Syndrome: A potentially
life-threatening problem that can happen when medicines such as
BRINTELLIX are taken with certain other medicines. Symptoms may
include agitation, hallucinations, coma or other changes in mental
status; problems controlling movements or muscle twitching,
stiffness or tightness; fast heartbeat, high or low blood pressure;
sweating or fever; nausea, vomiting or diarrhea.
Abnormal bleeding or bruising: BRINTELLIX and other serotonergic
antidepressant medicines may increase your risk of bleeding or
bruising, especially if you take the blood thinner warfarin
(Coumadin®, Jantoven®), a non-steroidal
anti-inflammatory drug (NSAID), or aspirin.
Manic episode: Symptoms may include greatly increased energy;
severe trouble sleeping; racing thoughts; reckless behavior;
unusually grand ideas; excessive happiness or irritability; talking
more or faster than usual.
Low salt (sodium) levels in the blood: Symptoms may include
headache; difficulty concentrating, memory changes or confusion;
weakness and unsteadiness on your feet; and in severe or sudden
cases hallucinations, fainting, seizures or coma. If not treated,
severe low sodium levels can cause death.
Before starting BRINTELLIX, tell your healthcare provider
if you have or had liver problems, seizures or convulsions,
bipolar disorder (manic depression) or mania, low salt (sodium)
levels in your blood, bleeding problems, drink alcohol, have any
other medical conditions or if you are pregnant, nursing, plan to
become pregnant, or plan to nurse.
BRINTELLIX and some medicines may interact with each other,
may not work as well, or may cause serious side effects when taken
together. Tell your healthcare provider if you plan on or are
taking any other prescription and non-prescription medicines,
vitamins and herbal supplements including medicines for migraine
headaches, such as triptans; medicines used to treat mood, anxiety,
psychotic or thought disorders such as tricyclics, lithium, SSRIs,
SNRIs, bupropion, buspirone or antipsychotics; MAOIs including
linezolid (a specific antibiotic); over-the-counter supplements
such as tryptophan or St. John's
wort; and the following medicines: aspirin, NSAIDs, warfarin
(Coumadin®, Jantoven®), diuretics, rifampicin, carbamazepine,
phenytoin, quinidine, tramadol or fentanyl.
Common side effects of BRINTELLIX include: nausea,
constipation or vomiting. These are not all the possible side
effects of BRINTELLIX.
Do not start or stop taking BRINTELLIX without talking to
your healthcare provider first. Suddenly stopping BRINTELLIX
when you take higher doses may cause you to have side effects
including headache, stiff muscles, mood swings, sudden outbursts or
anger, dizziness or feeling lightheaded, or runny nose.
Until you know how BRINTELLIX affects you, do not drive, operate
heavy machinery or engage in other dangerous activities.
Avoid drinking alcohol while taking BRINTELLIX.
Talk to your healthcare provider.
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.
Please see full Prescribing Information and Medication
Guide for BRINTELLIX.
The Science of Major Depression
The
monoamine-deficiency theory posits that the underlying
pathophysiological basis of depression is a depletion of serotonin,
norepinephrine or dopamine in the central nervous system. The exact
cause of MDD is unknown. Research suggests that there are multiple
serotonin receptors that may be important in MDD and may influence
many biologic and neurologic processes. The release of
bio-chemicals, such as serotonin, dopamine and norepinephrine
enables impulses to be passed from one cell to another in the
nervous system.
Takeda and Lundbeck Alliance
In September 2007, Lundbeck and Takeda
Pharmaceutical Company Limited formed a strategic alliance for the
exclusive co-development and co-commercialization in the U.S. and
Japan of several compounds in
Lundbeck's pipeline for the treatment of mood and anxiety
disorders. The companies co-promote Brintellix in the U.S. The
Lundbeck–Takeda alliance in the U.S. benefits from the synergy of
Lundbeck's longstanding expertise and knowledge of psychiatry and
Takeda's understanding and established presence in the very
important primary care environment.
About Patient Assistance
Healthcare providers and
patients may call 1-800-830-9159 to learn more or obtain
application forms for the Help at Hand program, a Patient
Assistance Program to help qualified patients who may benefit from
Brintellix gain access to this therapy without financial
barriers.
About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY)
is a global pharmaceutical company specialized in brain diseases.
For more than 50 years, we have been at the forefront of research
within neuroscience. Our development and distribution of pioneering
treatments continues to make a difference to people living with
brain diseases. Our key areas of focus are alcohol dependence,
Alzheimer's disease, depression/anxiety, epilepsy, Huntington's
disease, Parkinson's disease, schizophrenia and stroke. Lundbeck's
U.S. business is based in Deerfield,
Illinois. To learn more about Lundbeck in the U.S., visit
www.lundbeckus.com.
Our approximately 6,000 employees in 57 countries are engaged in
the entire value chain throughout research, development,
production, marketing and sales, and are committed to improving the
quality of life of people living with brain diseases. Our pipeline
consists of several late-stage development programs and our
products are available in more than 100 countries. We have research
centers in China, Denmark and the
United States, and production facilities in China, Denmark, France, Italy
and Mexico. Lundbeck generated
revenue of approximately DKK15
billion in 2012 (EUR 2
billion; USD 2.7 billion).
Lundbeck's shares are listed on the stock exchange in
Copenhagen under the symbol "LUN."
Lundbeck has a sponsored Level 1 ADR program listed in the US (OTC)
under the symbol "HLUYY." For additional information, we encourage
you to visit our corporate site www.lundbeck.com.
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 patients worldwide through leading innovation in
medicine. Additional information about Takeda is available through
its corporate website, www.takeda.com.
About Takeda Pharmaceuticals U.S.A., Inc. and Takeda Development Center
Americas, Inc.
Based in Deerfield,
Ill., Takeda Pharmaceuticals U.S.A., Inc. and Takeda Development Center
Americas, Inc. are subsidiaries of Takeda Pharmaceutical Company
Limited, the largest pharmaceutical company in Japan. The respective companies currently
market oral diabetes, CNS, rheumatology, gastroenterology and
cardiovascular disease treatments and seek to bring innovative
products to people through a pipeline that includes compounds in
development for diabetes, gastroenterology, neurology and other
conditions. To learn more about these Takeda companies, visit
www.takeda.us.
This press release contains forward-looking statements.
Forward-looking statements include statements regarding Takeda's
plans, outlook, strategies, results for the future, and other
statements that are not descriptions of historical facts.
Forward-looking statements may be identified by the use of
forward-looking words such as "may," "believe," "will," "expect,"
"project," "estimate," "should," "anticipate," "plan," "assume,"
"continue," "seek," "pro forma," "potential," "target," "forecast,"
"guidance," "outlook" or "intend" or other similar words or
expressions of the negative thereof. Forward-looking statements are
based on estimates and assumptions made by management that are
believed to be reasonable, though they are inherently uncertain and
difficult to predict. Investors are cautioned not to unduly rely on
such forward-looking statements.
Forward-looking statements involve risks and uncertainties
that could cause actual results or experience to differ materially
from that expressed or implied by the forward-looking statements.
Some of these risks and uncertainties include, but are not limited
to, (1) the economic circumstances surrounding Takeda's business,
including general economic conditions in Japan, the United
States and worldwide; (2) competitive pressures and
developments; (3) applicable laws and regulations; (4) the success
or failure of product development programs; (5) actions of
regulatory authorities and the timing thereof; (6) changes in
exchange rates; (7) claims or concerns regarding the safety or
efficacy of marketed products or product candidates in development;
and (8) integration activities with acquired companies.
The forward-looking statements contained in this press
release speak only as of the date of this press release, and Takeda
undertakes no obligation to revise or update any forward-looking
statements to reflect new information, future events or
circumstances after the date of the forward-looking statement. If
Takeda does update or correct one or more of these statements,
investors and others should not conclude that Takeda will make
additional updates or corrections.
Contacts
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Ashleigh
Duchene
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Roseanne
Durril
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Public
Affairs
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Corporate
Communications
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Lundbeck
US
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Takeda
Pharmaceuticals U.S.A., Inc.
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847-282-1164
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224-554-1474
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Takeda Pharmaceutical
Company Limited
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Corporate
Communications Dept.
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+81-3-3278-2037
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[1] Keller, A,
McGarvey, E. L., & Clayton, A. H. (2006). Reliability and
construct validity of the Changes in Sexual Functioning
Questionaire Short-Form (CSFQ-14). Journal of Sex and Marital
Therapy, 32, 43-52.
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SOURCE Takeda Pharmaceutical Company Limited