Johnson & Johnson
Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced that it
has submitted a New Drug Application to the U.S. Food and Drug
Administration (FDA) for paliperidone palmitate, an investigational,
once-monthly atypical antipsychotic intramuscular injection, for the
treatment of schizophrenia and the prevention of recurrence of the symptoms
of schizophrenia.
Paliperidone palmitate is a long-acting injectable ester of the active
ingredient in INVEGA(TM)(1) which utilizes Elan's NanoCrystal(R)
Technology. Upon approval, paliperidone palmitate will be marketed in the
U.S. by Janssen, L.P.
Worldwide, it is estimated that one person in every 100 develops
schizophrenia, one of the most serious types of mental illness. In the
United States, there are currently 2,000,000 people with schizophrenia,
with men and women affected equally. The disease is marked by positive
symptoms (hallucinations and delusions) and negative symptoms (depression,
blunted emotions, and social withdrawal), as well as by disorganized
thinking.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
(J&JPRD) is headquartered in Raritan, New Jersey (USA), and has nine sites
throughout Europe and the United States. J&JPRD employs approximately 3,500
people and is leveraging drug discovery, drug evaluation, and drug
development in a variety of therapeutic areas to address unmet medical
needs worldwide. The company's major therapeutic areas of focus include
hematology, oncology, infectious disease, obesity and metabolic disorders,
neurology and psychiatry, pain and women's health.
Janssen, L.P., based in Titusville, N.J., is a subsidiary of Johnson &
Johnson, and is the only pharmaceutical company in the U.S. dedicated
solely to mental health. The company currently markets prescription
medications for the treatment of schizophrenia, bipolar mania, and
irritability associated with autistic disorder. For more information about
Janssen, L.P., visit janssen
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 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 the Company's Annual Report
on Form 10-K for the fiscal year ended December 31, 2006. Copies of this
Form 10-K, as well as subsequent filings, are available online at
sec, jnj or on request from Johnson & Johnson. Johnson &
Johnson does not undertake to update any forward- looking statements as a
result of new information or future events or developments.
IMPORTANT SAFETY INFORMATION FOR INVEGA(TM)
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.
The most common side effects that occurred with INVEGA were
restlessness and extrapyramidal disorder (for example: involuntary
movements, tremors and muscle stiffness).
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.
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.
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.
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.
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.
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.
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.
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. Do not breast-feed if you are
taking INVEGA.
INVEGA may affect your driving ability; therefore, do not drive or
operate machines before talking to your healthcare professional. Avoid
alcohol while on INVEGA.
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.
Janssen, L.P. Web site: janssen
Johnson & Johnson Pharmaceutical Research & Development, LLC Web site:
jnjpharmarnd
NanoCrystal(R) Technology is a registered trademark of Elan Pharma
International Limited, Ireland, a subsidiary of Elan Corporation plc (NYSE:
ELN).
(1) INVEGA(TM) is a once-daily oral atypical antipsychotic for the
treatment and maintenance of schizophrenia. INVEGA was discovered and
developed by Johnson & Johnson Pharmaceutical Research & Development,
L.L.C (J&JPRD), and is marketed in the U.S. by Janssen, L.P.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
jnjpharmarnd
View drug information on Invega.