CAMBRIDGE, Mass.--(BUSINESS WIRE)--April 14, 2008--Alkermes, Inc.
(NASDAQ: ALKS) today announced that its partner, Johnson & Johnson
Pharmaceutical Research & Development, L.L.C. (J&JPRD), submitted a
Supplemental New Drug Application (sNDA) for RISPERDAL(R) CONSTA(R)
((risperidone) Long-Acting Injection) to the U.S. Food and Drug
Administration (FDA) seeking approval for adjunctive maintenance
treatment to delay the occurrence of mood episodes in patients with
frequently relapsing bipolar disorder (FRBD).
FRBD is defined as four or more manic or depressive episodes in
the previous year that require a doctor's care. The condition may
affect 10 to 20 percent of the 27 million people with bipolar disorder
The sNDA is based on results from a recent study comparing
patients who received RISPERDAL CONSTA and standard treatment to those
who received standard treatment combined with placebo. The study found
that patients with FRBD had a significant delay in the time to an
initial relapse when RISPERDAL CONSTA was combined with standard
treatment. The study was presented at the 14th Biennial Winter
Workshop on Schizophrenia and Bipolar Disorders in Montreux,
Switzerland on February 3, 2008.
RISPERDAL CONSTA was approved for the treatment of schizophrenia
in the U.S. in 2003. RISPERDAL CONSTA is marketed by Janssen, Division
of Ortho-McNeil-Janssen Pharmaceuticals, Inc., in the U.S. and is
manufactured by Alkermes.
RISPERDAL CONSTA is the first and only long-acting, atypical
antipsychotic to be approved by the FDA and now is approved in more
than 80 countries worldwide. The medication uses Alkermes' proprietary
Medisorb(R) technology to deliver and maintain therapeutic medication
levels in the body through just one injection every two weeks.
Available in 12.5 mg, 25 mg, 37.5 mg and 50 mg dose units, RISPERDAL
CONSTA is approved for the treatment of schizophrenia. For more
information about RISPERDAL CONSTA, visit
About Bipolar Disorder
It is estimated that 27 million people worldwide suffer from
bipolar disorder, also known as manic-depressive disorder. It is
characterized by debilitating mood swings, from extreme highs (mania)
to extreme lows (depression). Signs of mania include euphoria, extreme
irritability or rage, accelerated or disorganized thinking and an
increase in risky behaviors. Signs of depression include intense
sadness or despair, loss of energy, insomnia and suicidal thoughts.
Approximately 10 to 20 percent of patients with bipolar disorder
seen in mood disorder clinics are identified as "rapid-cycling" and
have had four or more episodes during the previous 12 months. The
types of mood episodes (manic, depressed, mixed) seen in these
patients can occur in any pattern. The course of their illness is
characterized by a requirement for more healthcare resources, more
concomitant medications and poorer outcomes.
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.
In a study of people taking RISPERDAL CONSTA, the most common side
effects in the treatment of schizophrenia were sleepiness,
restlessness, tremors and muscle stiffness, stomach upset,
constipation, dry mouth, feeling tired and weight increase.
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
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.
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.
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.
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
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
Inform your healthcare professional if you become pregnant or
intend to become pregnant during therapy with RISPERDAL CONSTA. Also,
tell your healthcare professional if you are planning to breast-feed.
RISPERDAL CONSTA may affect your alertness or driving ability;
therefore, do not drive or operate machinery before talking to your
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.
If you have any questions about RISPERDAL CONSTA or your therapy,
talk with your doctor.
Alkermes, Inc., a biotechnology company committed to developing
innovative medicines to improve patients' lives, manufactures
RISPERDAL(R) CONSTA(R) for schizophrenia and developed and
manufactures VIVITROL(R) for alcohol dependence. Alkermes' robust
pipeline includes extended-release injectable, pulmonary and oral
products for the treatment of prevalent, chronic diseases, such as
central nervous system disorders, addiction and diabetes.
Headquartered in Cambridge, Massachusetts, Alkermes has research and
manufacturing facilities in Massachusetts and Ohio. For more
information about Alkermes, visit http://www.alkermes.com.
Certain statements set forth above may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Although the company believes that such statements
are based on reasonable assumptions within the bounds of its knowledge
of its business and operations, the forward-looking statements are
neither promises nor guarantees and the company's business is subject
to significant risk and uncertainties and there can be no assurance
that its actual results will not differ materially from its
expectations. These risks and uncertainties include, among others,
decisions by the FDA relating to the recently submitted sNDA for
RISPERDAL CONSTA for the treatment of FRBD. For further information
with respect to factors that could cause the company's actual results
to differ materially from expectations, reference is made to the
reports the company filed with the Securities and Exchange Commission
under the Securities Exchange Act of 1934, as amended. The
forward-looking statements made in this release are made only as of
the date hereof and the company disclaims any intention or
responsibility for updating predictions or financial expectations
contained in this release.
Medisorb is a registered trademark of Alkermes, Inc., VIVITROL is
a registered trademark of Cephalon, Inc. and RISPERDAL CONSTA is a
registered trademark of Janssen-Cilag.
(1) The Global Burden of Disease. World Health Organization, 2003.
accessed March 20, 2008.
(2) DSM-IV-TR, American Psychiatric Association, 2000.
CONTACT: Alkermes, Inc.
Rebecca Peterson, 617-583-6378
SOURCE: Alkermes, Inc.