Noven Receives FDA Approval for BrisdelleTM (Paroxetine) Capsules, the First
Nonhormonal Therapy for Vasomotor Symptoms Associated with Menopause
Brisdelle™ is the first and only FDA-approved nonhormonal therapy clinically proven to treat
moderate to severe menopausal vasomotor symptoms
Miami, FL and New York, NY, June 28, 2013 -
Noven Pharmaceuticals, Inc., today announced that
the U.S. Food and Drug Administration (FDA) has approved Brisdelle™ low-dose paroxetine capsules,
7.5 mg/day, for the treatment of moderate to severe vasomotor symptoms (VMS) associated with
menopause, commonly referred to as hot flashes and night sweats. Prior to the approval of Brisdelle™,
hormone therapy was the only FDA-approved treatment for VMS. Many women are unable or
unwilling to take hormone therapy to treat their VMS associated with menopause, often leaving
“Noven is proud to have developed Brisdelle™, the first and only FDA-approved nonhormonal option
for the treatment of moderate to severe VMS, and to be the first company to offer both nonhormonal
and hormonal treatment options for women with VMS,” said Jeffrey F. Eisenberg, Noven’s President
and Chief Executive Officer. “We will commercialize Brisdelle™ in the U.S. through our Noven
Therapeutics Women’s Health division and we estimate that BrisdelleTM will be available in U.S.
pharmacies in November 2013.”
At the unique low dose of 7.5 mg of paroxetine as a mesylate salt, Brisdelle™ was specifically
developed for and studied in women who experience hot flashes and night sweats associated with
menopause. Brisdelle™ contains a lower dose of paroxetine than is indicated for any other condition.
“The FDA approval of Brisdelle™ addresses the unmet need for a clinically proven nonhormonal
treatment option for hot flashes and night sweats,” said David Portman,* M.D., Director of the
Columbus Center for Women’s Health Research and Brisdelle™ clinical trial investigator. “As a
clinician, the comprehensive prescribing information and proven data for Brisdelle™ enable me to
confidently offer women with moderate to severe VMS a nonhormonal option that is safe and
Brisdelle™ was clinically proven to reduce the frequency and severity of hot flashes and night sweats.
Brisdelle™ was studied in one Phase 2 and two Phase 3 randomized, placebo-controlled trials in 1,276
women with VMS associated with menopause. The most common adverse reactions, defined as those
experienced by at least 2 percent of patients taking Brisdelle™ compared to placebo were headache
(6.3 vs. 4.8 percent), fatigue/malaise/lethargy (4.9 vs. 2.8 percent) and nausea/vomiting (4.3 vs. 2.3
percent). Of these commonly reported adverse reactions, nausea occurred primarily within the first four
weeks of treatment and fatigue occurred primarily within the first week of treatment, and decreased in
frequency with continued therapy. Brisdelle™ shares paroxetine warnings and precautions.
“The approval of Brisdelle™ is significant because it meaningfully expands the therapeutic options for
the 24 million women in the U.S. affected by moderate to severe VMS, two-thirds of whom are not
currently treating these often debilitating symptoms,” said Joel Lippman, M.D., FACOG, Noven’s
Executive Vice President – Product Development and Chief Medical Officer. “Noven has long focused
on developing and offering therapies to address women’s menopausal health concerns, and we are
pleased to address the diverse needs of this population.”
In clinical development, Brisdelle™ was referred to as low-dose mesylate salt of paroxetine (LDMP)
To learn more about Brisdelle™, to register for updates, and for the full Prescribing Information,
including the Medication Guide, visit http://www.Brisdelle.com and read the Important Safety
BRISDELLE™ (Paroxetine) Capsules is a prescription medicine used to reduce moderate to severe hot
flashes associated with menopause.
BRISDELLE contains a lower dose of paroxetine, a medicine also used to treat a number of psychiatric
disorders. The lower dose of paroxetine in BRISDELLE has not been studied in any psychiatric
conditions and BRISDELLE is not approved for any psychiatric uses. IMPORTANT SAFETY INFORMATION
What is the most important information I should know about BRISDELLE?
Call your healthcare provider right away if you have any of the following symptoms, or go to the
nearest emergency room:
Suicidal thoughts or actions:
BRISDELLE, and related antidepressant medicines, may increase suicidal thoughts or
actions within the first few months of treatment.
Depression or other serious mental illnesses are the most important causes of suicidal thoughts
Watch for these changes and call your healthcare provider right away if you notice:
o New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially
o Pay particular attention to such changes when BRISDELLE is started.
Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
Nervousness, hallucinations, coma, or other changes in mental status;
coordination problems or small movements of the muscles that you cannot control; racing heartbeat,
high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle rigidity; dizziness;
flushing; tremors; seizures. Reduced effectiveness of tamoxifen:
Tamoxifen (a medicine used to treat breast cancer) may not
work as well if it is taken at the same time as BRISDELLE. If you are taking tamoxifen, tell your
healthcare provider before starting BRISDELLE.
BRISDELLE may increase your risk of bleeding or bruising, especially if you
take the blood thinner warfarin, or non-steroidal anti-inflammatory drugs (NSAIDs), like ibuprofen,
naproxen, or aspirin. Low salt (sodium) levels in the blood:
Elderly people may be at greater risk for this. Symptoms may
include: headache; weakness or feeling unsteady; confusion, problems concentrating or thinking or
memory problems. Bone Fractures:
Women who take BRISDELLE may have a higher risk of bone fractures.
Greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior;
unusually grand ideas; excessive happiness or irritability; talking more or faster than usual. Seizures or convulsions.
Women who take BRISDELLE may feel an inner restlessness, nervousness, or be unable
to sit still or stand still especially when they start taking BRISDELLE. Visual symptoms.
Who should not take BRISDELLE?
Do not take BRISDELLE if you:
Take a Monoamine Oxidase Inhibitor (MAOI)
, including the antibiotic linezolid. Unless
directed to do so by your physician, do not take an MAOI within 14 days of stopping BRISDELLE
and do not start BRISDELLE if you stopped taking an MAOI in the last 14 days. People who take
BRISDELLE close in time to an MAOI may have serious or life-threatening side effects.
Take thioridazine or pimozide.
Do not take thioridazine or pimozide together with BRISDELLE
because this can cause serious heart problems or sudden death.
. BRISDELLE is not for pregnant women. Paroxetine can harm your unborn baby.
What should I tell my healthcare provider before starting BRISDELLE?
Before starting BRISDELLE, tell your healthcare provider if you:
Have liver or kidney problems; bipolar disorder or mania; low sodium levels in your blood;
glaucoma (high pressure in the eye); have or had seizures, convulsions, or bleeding problems;
have any other medical conditions; are breastfeeding or plan to breastfeed
Tell your healthcare provider about all the medicines that you take
, including prescription and
non-prescription medicines such as migraine headache medication (triptans), other antidepressants and
antipsychotics, vitamins, and herbal supplements.
If you take BRISDELLE, you should not take any other medicines that contain paroxetine.
What should I avoid while taking BRISDELLE?
You should not drive, operate heavy machinery, or do other dangerous activities until you know how
BRISDELLE affects you.
What are the most common side effects of BRISDELLE?
The most common possible side effects of BRISDELLE include: headache; tiredness; nausea and
Tell your healthcare provider if you have any side effect that bothers you or does not go away. These
are not all the possible side effects of BRISDELLE.
Please read the Medication Guide within the full Prescribing Information before taking BRISDELLE. Call your doctor for medical advice about side effects. You may report side effects to the FDA at
During perimenopause, the transition period before a woman reaches menopause, estrogen levels
gradually decline and periods may become irregular. Natural menopause is typically confirmed when a
woman has missed her menstrual periods for 12 consecutive months. The average age of a woman
entering natural menopause is 51 years old. Some women may undergo surgical menopause, which can
take place at any age. Surgical menopause occurs when both ovaries are surgically removed (called an
oophorectomy), often along with the uterus (called a hysterectomy). Because ovaries are the body’s
main source of estrogen production, a woman enters menopause when they are removed. The severity
of symptoms associated with menopause varies from woman to woman. Hot flashes and night sweats
are the most common symptoms of menopause. Because the journey is unique for each woman, it is
important for women going through menopause to have a thorough discussion about the transition with
their doctors and determine if treatment is appropriate.
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research,
development, manufacturing, marketing and sale of prescription pharmaceutical products. Noven is
committed to developing and offering products and technologies that meaningfully benefit patients, its
customers and its industry partners, with a focus on treatment options for women experiencing
menopausal vasomotor symptoms. Noven is a stand-alone operating subsidiary of Japan-based
Hisamitsu Pharmaceutical Co., Inc., and serves as Hisamitsu’s U.S. growth platform in prescription
pharmaceuticals. For more information about Noven, visit www.noven.com. For information about
Hisamitsu, visit www.hisamitsu.co.jp/english.
* David Portman, M.D., is a compensated consultant for Noven Pharmaceuticals, Inc. Statements
attributed to Dr. Portman are his own opinions. Contacts
305-253-1916 Ashley Buford Director GolinHarris 212-373-6045
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