JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH
& DEVELOPMENT, L.L.C. ANNOUNCES FDA FILINGS FOR PALIPERIDONE
PALMITATE AND INVEGA
®
Titusville, N.J., Feb. 6, 2009 – Johnson
& Johnson Pharmaceutical Research & Development, L.L.C.
(J&JPRD) today announced that the company has submitted multiple
applications to the U.S. Food and Drug Administration (FDA) which,
if approved, would broaden treatment options for patients diagnosed
with schizophrenia or schizoaffective disorder.
Earlier this week, the company submitted its response to the FDA
complete response letter for paliperidone palmitate, received in
August 2008. Paliperidone palmitate is an investigational
once-monthly atypical antipsychotic injection which, if approved,
will be indicated for the acute and maintenance treatment of
schizophrenia. The company also submitted two supplemental new drug
applications (sNDAs) to the FDA requesting approval for the use of
INVEGA tablets for the treatment of schizoaffective disorder as
monotherapy and for use in combination with antidepressants and/or
mood stabilizers. The sNDA submissions include data from two
international, 6-week double-blind placebo-controlled studies that
evaluated the efficacy and safety of INVEGA in patients with
schizoaffective disorder. If approved by the FDA, INVEGA would be
the only medication indicated to treat the condition.
Patients with schizoaffective disorder experience the psychotic
symptoms of schizophrenia, such as hallucinations or delusions, as
well as mania and/or depression. Because of the similarity in
symptoms, schizoaffective disorder is sometimes misdiagnosed as
schizophrenia or bipolar disorder. For patients who frequently use
mental health services, schizophrenia and schizoaffective disorder
may account for approximately 32% and 24% of cases respectively.
INVEGA, an atypical antipsychotic medication, was first approved in
the U.S. in December 2006 and is marketed by Janssen. 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. If
approved, Janssen will also market paliperidone palmitate. Johnson
& Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is
a subsidiary of Johnson & Johnson, the world's most broadly-based
producer of health care products. J&JPRD is headquartered in
Raritan, N.J., and has facilities throughout Europe, the United
States and Asia. J&JPRD is leveraging drug discovery and drug
development in a variety of therapeutic areas, including CNS,
Internal Medicine and Oncology, to address unmet medical needs
worldwide. More information can be found at
http://www.jnjpharmarnd.com.
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 currently
markets 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.
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. 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 paliperidone 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 paliperidone 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 paliperidone. 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 paliperidone 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 paliperidone
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 paliperidone. 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.
Paliperidone 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 paliperidone. Some
people taking paliperidone 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.
Paliperidone may affect your driving ability; therefore, do not
drive or operate machinery before talking to your healthcare
professional. Avoid alcohol while on paliperidone.
Paliperidone 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 paliperidone. Caution
should be exercised when paliperidone is administered to a nursing
woman.
Paliperidone may affect alertness and motor skills; use caution
until the effect of paliperidone is known.
Paliperidone 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.
Paliperidone 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 paliperidone 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 the J&JPRD'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 30, 2007. 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.
J&JPRD does not undertake to update any forward-looking statements
as a result of new information or future events or developments.
References
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