FDA Approves New Injection Site for RISPERDAL(R) CONSTA(R) for Schizophrenia Treatment
October 09 2008 - 4:05PM
PR Newswire (US)
TITUSVILLE, N.J., Oct. 9 /PRNewswire-FirstCall/ -- Patients with
schizophrenia now have a new administration option for RISPERDAL(R)
CONSTA(R) ([risperidone] Long-Acting Injection). The U.S. Food and
Drug Administration (FDA) has approved a new injection site, the
deltoid muscle in the arm, for RISPERDAL CONSTA for the treatment
of patients with schizophrenia. RISPERDAL CONSTA was previously
approved as a gluteal injection only. "For many patients, this
injection site may be a good option, as it will provide them with a
choice of where to receive their long-acting therapy," said Dr.
Mohammed Bari, of Synergy Research Center in San Diego and one of
the investigators in the trial.* "The fact that they will just have
to roll up their sleeves and get the shot in their arm is going to
be a big plus for many patients with schizophrenia." The
application was based on a study showing that the deltoid and
gluteal injections of RISPERDAL CONSTA were bioequivalent(a) routes
of administration and thus interchangeable. An additional study was
conducted that showed the safety and tolerability of RISPERDAL
CONSTA injected into the deltoid muscle were similar to the gluteal
injections. Both studies were presented earlier this year at the
161st Annual Meeting of the American Psychiatric Association (APA)
in Washington, D.C., 2008.(1, 2) The new RISPERDAL CONSTA dose
packs will now include two separate (non-interchangeable) needles
for injection and will be available to U.S. physicians by the end
of 2008. The needle for deltoid injection is a smaller gauge and is
shorter in length than the gluteal needle. Both are administered
every two weeks. Not all patients will be appropriate for the
deltoid injection site. As with all medications, it's important
that patients discuss their treatment options with their healthcare
professional. RISPERDAL CONSTA is marketed in the U.S. by
Janssen(R), 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(R) 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. Worldwide, it is
estimated that one person in every 100 develops schizophrenia,(3)
one of the most serious types of mental illness. An estimated 2.4
million Americans have schizophrenia, with men and women affected
equally.(4) The disease is marked by positive symptoms
(hallucinations and delusions) and negative symptoms (depression,
blunted emotions and social withdrawal), as well by disorganized
thinking, speech and behavior. RISPERDAL(R) CONSTA(R) (risperidone)
is used for the treatment of schizophrenia. IMPORTANT SAFETY
INFORMATION FOR RISPERDAL(R) CONSTA(R) Elderly Patients with
dementia-related psychosis treated with atypical antipsychotic
drugs are at an increased risk of death compared to placebo.
RISPERDAL(R) CONSTA(R) (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(R) CONSTA(R) 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(R)
CONSTA(R) 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(R) CONSTA(R) 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(R) CONSTA(R). 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(R) CONSTA(R) 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(R) CONSTA(R) 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(R) CONSTA(R) may affect your alertness or driving
ability; therefore, do not drive or operate machinery before
talking to your healthcare professional. RISPERDAL(R) CONSTA(R)
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(R) CONSTA(R). Caution should
be exercised when RISPERDAL(R) CONSTA(R) is administered to a
nursing woman. RISPERDAL(R) CONSTA(R) 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(R) CONSTA(R). Please inform your healthcare professional
of any medications or supplements that you are taking. Avoid
alcohol while on RISPERDAL(R) CONSTA(R). In a study of people
taking RISPERDAL(R) CONSTA(R), 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(R) CONSTA(R) or your therapy, talk with
your doctor. * Mohammed Bari, M.D., is a consultant to Janssen,
Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. (a) The FDA
has defined bioequivalence as "the absence of a significant
difference in the rate and extent to which the active ingredient or
active moiety in pharmaceutical equivalents or pharmaceutical
alternatives becomes available at the site of drug action when
administered at the same molar dose under similar conditions in an
appropriately designed study." (FDA, 2003) References (1) Ning X,
Thyssen A, Quiroz J, et al. Tolerability and safety of long-acting
injectable risperidone in chronic schizophrenia subjects using
deltoid muscle as an alternative injection site. Presented at the
161st Annual Meeting of the American Psychiatric Association (APA)
in Washington, D.C. (2) Thyssen A, Ning X, Herben V, et al.
Pharmacokinetics of long-acting injectable risperidone injected in
deltoid muscle compared to gluteal muscle injection in subjects
with schizophrenia. Presented at the 161st Annual Meeting of the
American Psychiatric Association (APA) in Washington, DC (3) Royal
College of Psychiatrists website:
http://www.rcpsych.ac.uk/default.aspx?page=1643. Accessed April 14,
2008. (4) American Psychiatric Association. Let's talk facts about
schizophrenia. Available at:
http://healthyminds.org/factsheets/LTF-Schizophrenia.pdf. Accessed
April 1, 2008. DATASOURCE: Janssen, Division of
Ortho-McNeil-Janssen Pharmaceuticals, Inc. CONTACT: Media, Kara
Russell, +1-609-730-3592, , or Investors, Louise Mehrotra,
+1-732-524-6491, Lesley Fishman, +1-732-524-3922, both of Johnson
& Johnson Web Site: http://www.janssen.com/
Copyright