FDA Issues Complete Response Letter for RISPERDAL® CONSTA® for the Adjunctive Maintenance Treatment of Bipolar Disorder
TITUSVILLE, N.J., February 10, 2009 - Johnson & Johnson
Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced
today that the Food and Drug Administration (FDA) has asked for
additional information regarding the company's supplemental New
Drug Application (sNDA) for RISPERDAL® CONSTA (risperidone)
Long-Acting Injection. The sNDA, submitted in April 2008, sought
approval for RISPERDAL CONSTA for adjunctive maintenance treatment
to delay the occurrence of mood episodes in patients with bipolar
disorder who relapsed frequently.
The Agency's complete response outlined questions that need to be
addressed prior to granting approval for the new indication, but
did not request additional studies.
J&JPRD is currently evaluating the FDA's complete response letter
and will work with the Agency to resolve any outstanding questions.
Bipolar disorder is a brain disorder that causes unusual shifts in
a person's mood, energy and ability to function. It is often
characterized by debilitating mood swings from extreme highs
(mania) to extreme lows (depression), and affects 5.7 million, or
2.6 percent, of the American adult population in any given year.
RISPERDAL CONSTA is marketed in the U.S. by Janssen, Division of
Ortho-McNeil-Janssen Pharmaceuticals, Inc. and manufactured by
Alkermes, Inc. RISPERDAL CONSTA was initially approved for the
treatment of schizophrenia in the U.S. in 2003 and is registered in
more than 80 countries worldwide. Using Alkermes' proprietary
Medisorb drug-delivery technology, the RISPERDAL CONSTA
formulation encapsulates risperidone in microspheres made of a
biodegradable polymer, which are suspended in a water-based
solution and injected into the muscle. Laboratory and clinical
research has shown that the microspheres gradually degrade at a set
rate to provide therapeutic blood levels of the drug in the
bloodstream for an extended period. The polymer from which the
microspheres are made breaks down into two naturally occurring
compounds that are then eliminated by the body. Janssen, Division
of Ortho-McNeil-Janssen Pharmaceuticals, Inc., based in Titusville,
N.J., 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, visit http://www.janssen.com.
Ortho-McNeil-Janssen Pharmaceuticals, Inc. is a member of the
Johnson & Johnson family of companies.
RISPERDAL CONSTA (risperidone) is used for the treatment of
schizophrenia.
IMPORTANT SAFETY INFORMATION FOR RISPERDAL CONSTA
Elderly Patients with dementia-related psychosis treated with
atypical antipsychotic drugs are at an increased risk of death
compared to placebo. RISPERDAL CONSTA (risperidone) 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 RISPERDAL CONSTA 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 RISPERDAL CONSTA 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 RISPERDAL
CONSTA 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 RISPERDAL CONSTA.
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.
RISPERDAL CONSTA 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.
Some people taking RISPERDAL CONSTA 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 can be reduced or it may go away
over time.
RISPERDAL CONSTA may affect your alertness or driving ability;
therefore, do not drive or operate machinery before talking to your
healthcare professional.
RISPERDAL CONSTA 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 become pregnant or
intend to become pregnant during therapy with RISPERDAL CONSTA.
Caution should be exercised when RISPERDAL CONSTA is administered
to a nursing woman.
RISPERDAL CONSTA 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.
Some medications interact with RISPERDAL CONSTA. Please inform
your healthcare professional of any medications or supplements that
you are taking. Avoid alcohol while on RISPERDAL CONSTA.
In a study of people taking RISPERDAL CONSTA, the most common
side effects in the treatment of schizophrenia were headache,
tremors, dizziness, restlessness, tiredness, constipation,
indigestion, sleepiness, weight gain, pain in the limbs, and dry
mouth.
If you have any questions about RISPERDAL CONSTA or your therapy,
talk with your doctor.
(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 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.)
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