Novartis International AG / Novartis launches schizophrenia treatment Fanapt in the US, offering patients an attractive alternative to existing medications processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
* Fanapt proven effective for the acute treatment of schizophrenia in adults
* Fanapt offers patients a proven tolerability profile with discontinuation
rates similar to placebo
* Schizophrenia is a chronic, severe and disabling mental disorder, affecting
2.4 million Americans
* Despite available medications, there remains a need for additional treatment
Basel, January 11, 2010 - Novartis announced that Fanapt(TM) (iloperidone)
tablets are now available for use across the US for the acute treatment of
schizophrenia in adults. Fanapt is a twice-daily, oral antipsychotic, approved
by the US Food and Drug Administration (FDA) in May 2009.
"Schizophrenia remains one of the most debilitating and difficult to treat
mental illnesses. The launch of Fanapt is important because there is a need for
alternative medications for many individuals who are suffering from this
disease," said Ludwig Hantson, PhD, Head of Pharma North America, CEO, Novartis
Pharmaceuticals Corporation. "In clinical trials, Fanapt was shown to be
effective for the symptoms of schizophrenia. Fanapt also showed a low incidence
of certain side effects, and the percentage of patients who discontinued
treatment was similar to that of placebo."
Schizophrenia is a chronic, severe and disabling mental disorder, affecting 2.4
million Americans. People with schizophrenia have varying levels of response and
tolerance to available therapies. Despite the severe symptoms of this disorder,
as many as 74% of all patients discontinue their medication before completing
18 months of treatment, according to a major National Institute of Mental Health
(NIMH) study. In a separate trial, more than a quarter of patients changed their
medications within a year, with a mean time to switching of 100 days.
Fanapt is indicated for the acute treatment of schizophrenia in adults. In
clinical trials, treatment with Fanapt resulted in significant improvement in
symptoms of schizophrenia compared to patients on placebo as demonstrated on two
major scales for measuring the positive and negative symptoms of the disorder.
The most common adverse drug reactions were dizziness, dry mouth, fatigue, nasal
congestion, orthostatic hypotension, somnolence, tachycardia, and weight gain.
In clinical trials, discontinuation rates due to side effects for patients on
Fanapt and on placebo were similar. The incidence of akathisia, a feeling of
inner restlessness often associated with other antipsychotics, was also shown to
be similar between placebo and Fanapt - up to the maximum dose of 24 mg per day.
As many as 87% of patients taking Fanapt did not experience weight gain >= 7%
of body weight in clinical trials (88% for 10-16 mg doses; 82% for 20-24 mg
doses, and 87% for all patients in the trials). Across all short- and long-term
studies, the overall mean weight gain from baseline to end of the trial was 2.1
kg or less than five lbs. Additionally, patients did not experience medically
important changes in triglyceride and total cholesterol measurements. Fanapt
also demonstrated a low incidence that was similar to placebo of the following
extrapyramidal symptoms: parkinsonism, dystonia, dyskinesia and bradykinesia.
"Individuals with schizophrenia face enormous challenges, and while there is no
cure, it can be a manageable illness when a patient has the right medication,"
said Dr. Peter Weiden, MD, Director of the Psychotic Disorders Program and
Professor of Psychiatry at the University of Illinois at Chicago. "It is
important to have a therapeutic option like Fanapt that can manage symptoms and
enable functioning with a rate of akathisia no higher than placebo and without
medically relevant changes in triglycerides and total cholesterol levels."
Fanapt(TM) tablets are indicated for the acute treatment of schizophrenia in
adults and belongs to a class of medications for schizophrenia known as atypical
The FDA approval of Fanapt was supported by two placebo- and active-controlled
short-term (4- and 6-week) trials. Safety data was derived from more than 2,000
patients in short- and long-term studies. Both trials enrolled patients who met
the DSM-III/IV criteria for schizophrenia. Fanapt was shown to be superior to
placebo in controlling symptoms of schizophrenia using the Positive and Negative
Symptom Scale (PANSS) and the Brief Psychiatric Rating Scale (BPRS). Efficacy
was demonstrated across doses of 12 mg to 24 mg per day - which is the
recommended daily target dose range. Fanapt must be titrated slowly from a low
starting dose to avoid orthostatic hypotension; titration to the lowest
effective dose of 12 mg per day can be achieved in four days with the use of an
available titration pack. Fanapt can be administered without regard to meals.
The effectiveness of Fanapt for more than 6 weeks has not been systematically
evaluated in clinical trials. Therefore, the physician who elects to use Fanapt
for extended periods should periodically re-evaluate the long-term usefulness of
the drug for the individual patient.
Novartis has exclusive commercialization rights to the oral formulation of
Fanapt in the US and Canada under an agreement with Vanda Pharmaceuticals Inc.,
as well as exclusive rights to develop and commercialize a long-acting
injectable (or "depot") formulation of this medicine for these markets.
Schizophrenia is a chronic, severe and disabling mental disorder, characterized
by profound disruptions in thinking, affecting language, perception, and the
sense of self. It often includes psychotic experiences, such as hearing voices
or delusions. Schizophrenia typically begins in late adolescence or early
adulthood and affects 2.4 million Americans or 1.1% of the adult population.
IMPORTANT SAFETY INFORMATION FOR FANAPT (iloperidone) TABLETS
Elderly patients are at an increased risk of death when compared with patients
who are treated with a placebo. Fanapt is not approved for the treatment of
elderly patients (aged 65 and older) with psychosis related to dementia.
Serious Side Effects
Fanapt may change your heart rhythm (meaning there is more time between heart
beats). 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 had heart problems. Call your doctor right away if
you feel faint or have unpleasant feelings of irregular or forceful heart beats
as any of these feelings could be a sign of a rare, but serious side effect that
could be fatal.
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 which could be fatal.
Abnormal or uncontrollable movements of the face, tongue, or other parts of body
may be signs of a serious condition called tardive dyskinesia (TD), which could
If you have diabetes or risk factors for diabetes (for example, obesity, family
history of diabetes), or you have unexpected increases in thirst, urination, or
hunger, your blood sugar should be monitored. Increases in blood sugar levels
(hyperglycemia), in some cases serious and associated with coma or death, have
been reported in patients taking Fanapt and medicines like it.
Tell your doctor if you have a history of or are at risk for seizures, have
liver disease, or if you are pregnant or intend to become pregnant. Tell your
doctor about all prescription and nonprescription medicines you are taking,
since there are some risks for drug interactions.
Lightheadedness 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.
Decreases in white blood cells (infection-fighting cells) have been reported in
some patients taking antipsychotic agents, including Fanapt. Patients with a
history of a significant decrease in white blood cell (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.
Fanapt can increase the level of the hormone prolactin. Tell your doctor if you
have signs of high prolactin levels, such as breast enlargement, breast pain, or
Medicines like Fanapt can impact your body's ability to reduce your temperature.
You should avoid overheating. You should drink fluids so that you do not become
Fanapt and medicines like it have been associated with swallowing problems
(dysphagia). If you had or have swallowing problems, you should tell your
As with many conditions that affect the way you think and 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
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.
Common Side Effects
The most common side effects include dizziness, dry mouth, feeling unusually
tired or sleepy, stuffy nose, orthostatic hypotension, racing heart beat, and
weight gain. The average weight gain in clinical studies 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
If you would like more information, talk with your doctor. You can also visit
the Fanapt Web site at www.Fanapt.com <
http://www.fanapt.com/> or call Novartis
Pharmaceuticals Corporation at: 1-888-NOW-NOVA (1-888-669-6682) Monday-Friday,
8:30 am - 5:00 pm ET.
* For press release intended for US audiences, visit www.pharma.us.novartis.com
The foregoing release contains forward-looking statements that can be identified
by terminology such as "can," or similar expressions, or by express or implied
discussions regarding potential future revenues from Fanapt. You should not
place undue reliance on these statements. Such forward-looking statements
reflect the current views of management regarding future events, and involve
known and unknown risks, uncertainties and other factors that may cause actual
results to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no guarantee
that Fanapt will achieve any particular level of revenue in the future. In
particular, management's expectations regarding Fanapt could be affected by,
among other things, unexpected regulatory actions or delays or government
regulation generally; unexpected clinical trial results, including unexpected
new clinical data and unexpected additional analysis of existing clinical data;
competition in general; government, industry and general public pricing
pressures; the company's ability to obtain or maintain patent or other
proprietary intellectual property protection; the impact that