Noven Receives FDA Approval for Brisdelle™ (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
MIAMI, FLand NEW YORK, NY, June 28, 2013 /PRNewswire/ --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 Brisdelle™
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 effective."
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
In clinical development, Brisdelle™ was referred to as low-dose mesylate salt
of paroxetine (LDMP) and Mesafem.
To learn more about Brisdelle™, to register for updates, and for the full
Prescribing Information, including the Medication Guide, visit
www.Brisdelle.com and read the Important Safety Information below.
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:
oBRISDELLE, and related antidepressant medicines, may increase suicidal
thoughts or actions within the first few months of treatment.
oDepression or other serious mental illnesses are the most important causes
of suicidal thoughts or actions.
oWatch for these changes and call your healthcare provider right away if
oNew or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
oPay 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.
Serotonin Syndrome: 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;
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
Abnormal bleeding: 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
Manic episodes: 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.
Restlessness: 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.
Who should not take BRISDELLE?
Do not take BRISDELLE if you:
oTake 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
oTake thioridazine or pimozide. Do not take thioridazine or pimozide
together with BRISDELLE because this can cause serious heart problems or
oAre pregnant. 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:
oHave 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
If you take BRISDELLE, you should not take any other medicines that contain
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 vomiting.
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 1-800-FDA-1088.
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,
* David Portman, M.D., is a compensated consultant for Noven Pharmaceuticals,
Inc. Statements attributed to Dr. Portman are his own opinions.
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.
SOURCE Noven Pharmaceuticals, Inc.
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