Study Suggests Treatment with Paliperidone ER
Significantly Improves Symptoms of Schizoaffective Disorder
San Diego, Calif., Apr. 1, 2009 – Patients
with schizoaffective disorder who received paliperidone extended
release tablets (paliperidone ER) for six weeks showed significant
improvement in a broad range of schizoaffective symptoms, according
to a new study presented today at the 12th International Congress
on Schizophrenia Research (ICOSR) in San Diego, Calif.
1
The findings
of the study provide additional evidence for symptomatic
improvement of schizoaffective disorder following therapy with
paliperidone ER.
2
"This well-designed and conducted study of paliperidone ER in
patients with schizoaffective disorder found that this medication
is both efficacious and well-tolerated," said Nina Schooler, Ph.D.,
SUNY Downstate Medical Center. "These new data support the
potential use of paliperidone ER as an effective option for the
treatment of this understudied group of patients."
Schizoaffective disorder is a condition, which encompasses the
symptoms of both schizophrenia and a major mood disorder. Patients
with schizoaffective disorder experience the psychosis
characteristic of schizophrenia, such as hallucinations or
delusions, as well as symptoms of mania and/or depression.
3
Schizoaffective disorder can be difficult to distinguish from
schizophrenia or bipolar disorder because the symptoms are similar
to both. The disorder is about one third as common as schizophrenia
4
but within those people that frequently use mental health services,
schizophrenia and schizoaffective disorder may account for
approximately 32% and 24% of cases respectively.
5
In the six week, international, randomized, double-blind, placebo
controlled study, 311 patients with an established diagnosis of
schizoaffective disorder, who were experiencing acute symptoms,
were randomized to receive either paliperidone ER or a placebo. The
paliperidone ER dose was initiated at 6 mg/day and could be
adjusted in range from 3mg/day to 12mg/day up to day 15, after
which no dose adjustments were allowed. In addition to study
medication, subjects were permitted to receive concomitant
treatment with an antidepressant and/or mood stabilizer, provided
these medications had been given at a stable dose within 30 days of
screening. Approximately half the subjects enrolled received
ongoing treatment with an antidepressant and/or mood stabilizer
during the study.
Based on the primary outcome parameter of change in PANSS total
score from baseline to week 6 endpoint results showed that patients
in the paliperidone ER group had significantly greater improvement
as compared to patients on placebo (p=0.001). Changes were also
noted in many secondary outcomes parameters measured in the trial.
The paliperidone ER group exhibited a significant improvement in
mean Clinical Global Impressions of Severity for Schizoaffective
Disorder (CGI-S-SCA) scores when compared to patients taking
placebo (p=0.002). Further, among patients with prominent manic
symptoms as measured by the Young Mania Ratings Scale (YMRS score
≥16) paliperidone ER exhibited significant improvement compared
to placebo on the YMRS (p=0.001). Likewise, among patients with
prominent depressive symptoms as measured by the Hamilton Rating
Scale for Depression (HAM-D-21 score ≥16), paliperidone ER
exhibited significant improvements compared to placebo on the
HAM-D-21 (p<0.001).
The most common adverse events occurring in this trial were:
headache (32%), dizziness (18%), insomnia (14%), akathisia (13%)
and dyspepsia (12%).
The study was sponsored by Ortho-McNeil Janssen Scientific Affairs,
LLC.
Paliperidone ER, an atypical antipsychotic medication, was first
approved in the U.S. in December 2006. Janssen, Division of
Ortho-McNeil-Janssen Pharmaceuticals, Inc., markets paliperidone ER
as INVEGA®. It is approved for the acute and maintenance treatment
of schizophrenia in the U.S. and for the treatment of schizophrenia
in the E.U.
In February 2009, two supplemental new drug applications (sNDAs)
were submitted to the FDA requesting approval for the use of
paliperidone ER for the treatment of schizoaffective disorder as
monotherapy and for use in combination with antidepressants and/or
mood stabilizers. If approved by the FDA, INVEGA would be the only
medication indicated to treat the condition.
Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is
based in Titusville, N.J. and is the only large pharmaceutical
company in the U.S. dedicated solely to mental health. It has
prescription medications for the treatment of schizophrenia,
bipolar mania and the treatment of symptoms associated with
autistic disorder. For more information about Janssen, visit
http://www.janssen.com.
Ortho-McNeil Janssen Scientific Affairs, LLC, and Janssen, Division
of Ortho-McNeil-Janssen Pharmaceuticals, Inc., are part of the
Johnson & Johnson family of companies.
IMPORTANT SAFETY INFORMATION FOR INVEGA®
Elderly Patients with dementia-related psychosis treated with
atypical antipsychotic drugs are at an increased risk of death
compared to placebo. INVEGA® (paliperidone) is not approved for the
treatment of patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS) is a rare and potentially
fatal side effect reported with INVEGA® and similar medicines. Call
your doctor immediately if the person being treated develops
symptoms such as high fever; stiff muscles; shaking; confusion;
sweating; changes in pulse, heart rate, or blood pressure; or
muscle pain and weakness. Treatment should be stopped if the person
being treated has NMS.
One risk of INVEGA® is that it may change your heart rhythm. This
effect is potentially serious, and you should talk to your doctor
about any current or past heart problems. Some medications interact
with INVEGA®. Please inform your healthcare professional of any
medications or supplements that you are taking.
Tardive Dyskinesia (TD) is a serious, sometimes permanent side
effect reported with INVEGA® and similar medications. TD includes
uncontrollable movements of the face, tongue, and other parts of
the body. The risk of developing TD and the chance that it will
become permanent is thought to increase with the length of therapy
and the overall dose taken by the patient. This condition can
develop after a brief period of therapy at low doses, although this
is much less common. There is no known treatment for TD, but it may
go away partially or completely if therapy is stopped.
High blood sugar and diabetes have been reported with INVEGA® and
similar medications. If the person being treated has diabetes or
risk factors such as being overweight or a family history of
diabetes, blood sugar testing should be performed at the beginning
and throughout treatment with INVEGA®. Complications of diabetes
can be serious and even life threatening. If signs of high blood
sugar or diabetes develop, such as being thirsty all the time,
going to the bathroom a lot, or feeling weak or hungry, contact
your doctor.
INVEGA® and similar medications can raise the blood levels of a
hormone known as prolactin, causing a condition known as
hyperprolactinemia. Blood levels of prolactin remain elevated with
continued use. Some side effects seen with these medications
include the absence of a menstrual period; breasts producing milk;
the development of breasts by males; and the inability to achieve
an erection. The connection between prolactin levels and side
effects is unknown.
People with narrowing or blockage of the gastrointestinal tract
(esophagus, stomach or small or large intestine) should talk to
their healthcare professional before taking INVEGA®.
Some people taking INVEGA® may feel faint or lightheaded when they
stand up or sit up too quickly. By standing up or sitting up slowly
and following your healthcare professional's dosing instructions,
this side effect may be reduced or it may go away over time.
INVEGA® may affect your driving ability; therefore, do not drive or
operate machinery before talking to your healthcare professional.
Avoid alcohol while on INVEGA®.
INVEGA® should be used cautiously in people with a seizure
disorder, who have had seizures in the past, or who have conditions
that increase their risk for seizures.
Extrapyramidal Symptoms (EPS) are usually persistent movement
disorders or muscle disturbances, such as restlessness, tremors,
and muscle stiffness. If you observe any of these symptoms, talk to
your healthcare professional.
Inform your healthcare professional if you are pregnant or if you
are planning to get pregnant while taking INVEGA®. Caution should
be exercised when INVEGA® is administered to a nursing woman.
INVEGA® may affect alertness and motor skills; use caution until
the effect of INVEGA® is known.
INVEGA® may make you more sensitive to heat. You may have trouble
cooling off, or be more likely to become dehydrated, so take care
when exercising or when doing things that make you warm.
INVEGA® should be swallowed whole. Tablets should not be chewed,
divided, or crushed. Do not be worried if you see something that
looks like a tablet in your stool. This is what is left of the
tablet after all the medicine has been released.
The most common side effects that occurred with INVEGA® were
restlessness and extrapyramidal disorder (for example, involuntary
movements, tremors and muscle stiffness).
Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" as defined
in the Private Securities Litigation Reform Act of 1995. These
statements are based on current expectations of future events. If
underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could vary materially
from Janssen and/or Johnson & Johnson's expectations and
projections. Risks and uncertainties include general industry
conditions and competition; economic conditions, such as interest
rate and currency exchange rate fluctuations; technological
advances and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approvals; domestic and foreign health care reforms and
governmental laws and regulations; and trends toward health care
cost containment. A further list and description of these risks,
uncertainties and other factors can be found in Exhibit 99 of
Johnson & Johnson's Annual Report on Form 10-K for the fiscal year
ended December 28, 2008. Copies of this Form 10-K, as well as
subsequent filings, are available online at www.sec.gov,
www.jnj.com or on request from Johnson & Johnson. Neither Janssen
nor Johnson & Johnson undertake to update any forward-looking
statements as a result of new information or future events or
developments.
References
________________________________
|
