WASHINGTON, Nov. 1, 2018 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it
received a letter from the U.S. Food and Drug Administration (FDA)
Office of Prescription Drug Promotion on October 22, 2018 regarding the content on a
single page of its corporate website. Vanda modified the content of
this webpage on October 23, 2018. The
webpage is shown here in its prior and current forms.
To access the FDA letter, which was published on October 31, 2018, please refer to the FDA's
website here. Vanda intends to meet with the FDA to better
understand the reasoning of the letter.
About Vanda
Vanda is a global biopharmaceutical company focused on the
development and commercialization of innovative therapies to
address high unmet medical needs and improve the lives of patients.
For more on Vanda Pharmaceuticals Inc., please
visit www.vandapharma.com.
About Fanapt®
Fanapt® is an atypical antipsychotic approved
for the treatment of schizophrenia in adults.
Fanapt® is a serotonin (5-HT2) receptor and
dopamine receptor antagonist.
Fanapt® received US Market Approval by the FDA
in May 2009. In addition, Vanda
currently has Fanapt® distribution partnerships in
Israel and Mexico. In 2012, Fanapt® was
approved for marketing in Israel
and Argentina.
Indication and Important Safety Information About
Fanapt®
Indication
Fanapt® (iloperidone) tablets are indicated for the
treatment of schizophrenia in adults.
Deciding to look at alternate medications is something your
doctor may do. Your doctor needs to consider that
Fanapt® may change your heart rhythm (meaning there is
more time between heartbeats). When taking other drugs that may
cause this same change in heart rhythm, you are at a higher risk of
a serious, even life-threatening medical issue (torsade de
pointes), which may result in sudden death. In many cases, your
doctor may prescribe another medication like Fanapt®
first.
Fanapt® needs to be taken as directed starting at a
low dose and slowly increasing the strength. This may delay the
control of symptoms in the first 1 to 2 weeks of
treatment.
Important Safety Information
BOXED WARNING:
Elderly patients with psychosis related to dementia (having lost
touch with reality due to memory loss and experiencing a decline in
day-to-day functioning) who are treated with antipsychotic
medications are at an increased risk of death compared to patients
treated with a placebo. Fanapt® is not approved for the
treatment of people with dementia-related psychosis.
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Patients should not use Fanapt® if they have a known
allergy to Fanapt® or its ingredients. Allergic
reactions, including anaphylaxis, rapid swelling of the skin
(angioedema), and other symptoms of allergy (eg, throat tightness;
swelling of the throat, face, lips, mouth and tongue; hives; rash;
and itching) have been reported.
An increased risk of stroke (including death) has been reported
in clinical studies of elderly people with dementia-related
psychosis. Fanapt® is not approved for the
treatment of people with dementia-related psychosis.
Fanapt® may change your heart rhythm (mean there is
more time between heartbeats). Heart rhythm changes have occurred
in patients taking Fanapt® and are a risk factor for
serious, even life-threatening medical issues. You should tell your
doctor if you have or have had heart problems. Contact your doctor
right away if you feel faint or have unpleasant feelings of
irregular or forceful heartbeats as any of these feelings could be
a sign of a rare, but serious side effect that could be fatal. You
should not use Fanapt® with other drugs that are known
to cause these same heart rhythm issues.
Tell your doctor if you have some or all of the following
symptoms; Very high fever, rigid muscles, shaking, confusion,
sweating or increased heart rate and blood pressure. These may be
signs of a condition called neuroleptic malignant syndrome (NMS), a
rare but serious side effect that could be fatal. This may happen
with Fanapt® or drugs like it.
Abnormal or uncontrollable movements of the face, tongue, or
other parts of the body may be signs of a serious condition called
tardive dyskinesia (TD), which could become permanent. The chance
of this condition going away decreases, depending on how long and
how much medication has been taken. Tell your doctor if you have
body movements you can't control.
Fanapt® and medicines like it have been associated
with metabolic changes (high blood sugar, high cholesterol and
triglycerides, and weight gain) that can increase
cardiovascular/cerebrovascular risks.
Tell your doctor if you have diabetes or risk factors for
diabetes (for example, obesity, family history of diabetes), or if
you have unexpected increases in thirst, urination, or hunger. If
so, your blood sugar should be monitored. Increases in blood sugar
levels (hyperglycemia), which in some cases can be serious and
associated with coma or death, have been reported in patients
taking Fanapt® and medicines like it.
Changes in cholesterol and triglycerides have been seen in
patients taking Fanapt® and medicines like it. Check
with your doctor while on treatment.
Some patients may gain weight while taking Fanapt®.
Your doctor should check your weight regularly.
Tell your doctor about any medical conditions that you have
including problems with your liver. Fanapt® is not
recommended for patients with severe liver problems.
Tell your doctor if you have a history of or have a condition
that may increase your risk for seizures before you begin taking
Fanapt®.
Light-headedness or faintness caused by a sudden change in heart
rate and blood pressure when rising quickly from a sitting or lying
position (orthostatic hypotension) has been reported with
Fanapt®. This condition is most common when you start
therapy, when re-starting treatment, or when the dose of
Fanapt® is increased. You should consult your doctor if
you have or have had heart problems or conditions that lead to
these sudden changes since Fanapt® should be used with
caution in these patients.
Fanapt® may increase the risk of falls, which could
cause fractures or other injuries.
Decreases in infection-fighting white blood cells (WBCs) have
been reported in some patients taking antipsychotic agents.
Patients with a preexisting history of low WBC count or who have
experienced a low WBC count due to drug therapy should have their
blood tested and monitored during the first few months of therapy.
Some (including fatal) cases of agranulocytosis, a serious decrease
in specific types of WBCs called neutrophils or granulocytes, have
been reported in drugs like Fanapt®.
Fanapt® can increase the level of the hormone
prolactin. Tell your doctor if you experience breast enlargement,
breast pain, or breast discharge, abnormal menstrual cycles in
females or impotence in males. If elevated levels of prolactin
persist, this may lead to bone loss.
Medicines like Fanapt® can impact your body's ability
to reduce your body temperature. You should avoid overheating and
dehydration.
Fanapt® and medicines like it have been associated
with swallowing problems (dysphagia). If you have or have had
swallowing problems, you should tell your doctor.
As with many conditions that affect the way you think or feel,
thoughts of suicide may occur. If you get these feelings, seek help
immediately from your doctor, or local emergency room.
For males, in the rare event you have a painful or prolonged
erection (priapism), lasting 4 or more hours, stop using
Fanapt® and seek immediate medical attention.
Fanapt® and medicines like it can affect your
judgment, thinking, or motor skills. You should not drive or
operate hazardous machinery, including automobiles, until you know
how Fanapt® affects you.
The most common side effects for Fanapt® versus
placebo were dizziness, dry mouth, feeling unusually tired or
sleepy, stuffy nose, feeling faint/light-headed when standing
quickly, racing heartbeat, and weight gain. The average weight gain
in clinical studies lasting 4-6 weeks was 5 lbs. If you experience
any of these symptoms, talk with your doctor.
When taking Fanapt®, you should avoid drinking
alcohol, and you should not breastfeed. You should notify your
doctor if you become pregnant or intend to become pregnant while
taking Fanapt®. Tell your doctor about all prescription
and nonprescription medicines and supplements you are taking. Some
medications may interact with Fanapt®.
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.
Full U.S. prescribing information, including box warnings and
safety information, can be found at: www.fanapt.com.
About Hetlioz®
HETLIOZ® is a melatonin receptor agonist.
HETLIOZ® received U.S. Food and Drug Administration
approval in January 2014 for the
treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).
HETLIOZ® received European Commission approval in
July 2015 for the treatment of Non-24
in totally blind adults in the European Union.
Non-24 is a chronic, circadian rhythm disorder resulting from
the misalignment of the endogenous master body clock to the 24-hour
day, disrupting the sleep-wake cycle. The sleep disturbance causes
significant distress or impairment in social, occupational and
other important areas of functioning. Non-24 affects the majority
of totally blind individuals and it is estimated that approximately
80,000 Americans have the disorder.
For more information about HETLIOZ® call
1-844-HETLIOZ (1-844-438-5469).
Indication and Important Safety Information About
HETLIOZ®
Indication
HETLIOZ® is indicated for the treatment of
Non-24-Hour Sleep-Wake Disorder (Non-24).
Important Safety Information
HETLIOZ® may cause somnolence: After taking
HETLIOZ®, patients should limit their activity to
preparing for going to bed, because HETLIOZ® can
impair the performance of activities requiring complete mental
alertness.
The most common adverse reactions (incidence >5% and at least
twice as high on HETLIOZ® than on placebo) were
headache, increased alanine aminotransferase, nightmares or unusual
dreams, upper respiratory or urinary tract infection. The risk of
adverse reactions may be greater in elderly (>65 years) patients
than younger patients because exposure to
HETLIOZ® is increased by approximately 2-fold
compared with younger patients.
Use of HETLIOZ® should be avoided in combination
with fluvoxamine or other strong CYP1A2 inhibitors, because of a
potentially large increase in exposure of HETLIOZ®, and
a greater risk of adverse reactions.
HETLIOZ® should be avoided in combination with
rifampin or other CYP3A4 inducers, because of a potentially large
decrease in exposure of HETLIOZ®, with reduced
efficacy.
There are no adequate and well-controlled studies of
HETLIOZ® in pregnant women. Based on animal data,
HETLIOZ® may cause fetal harm.
HETLIOZ® should be used during pregnancy only if
the potential benefit justifies the potential risks. Caution should
be exercised when HETLIOZ® is administered to a
nursing woman.
HETLIOZ® has not been studied in patients with
severe hepatic impairment and is not recommended in these
patients.
Safety and effectiveness of HETLIOZ® in
pediatric patients have not been established.
Full HETLIOZ® Prescribing Information can be
found at: www.hetlioz.com.
HETLIOZ® is a registered trademark of Vanda
Pharmaceuticals Inc.
Company Contact:
Jim Kelly
Executive Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.