TITUSVILLE, N.J., Dec. 10 /PRNewswire/ -- Treatment with
once-monthly INVEGA® SUSTENNA(TM) is not inferior to treatment with
bi-weekly RISPERDAL® CONSTA®, according to new data from a
comparative study of both treatments in patients with
schizophrenia. Results of the 13-week clinical trial were released
this week. An estimated one percent of the world's population
suffers from schizophrenia - a brain disorder that impairs a
person's ability to think clearly, relate to others, and
distinguish between reality and imagination. In the U.S.,
approximately 2.4 million Americans have schizophrenia, with men
and women affected equally.(1) Non-adherence to medication
treatment is a common problem encountered in patients with
schizophrenia, which can lead to relapse (an increase in symptoms)
and hospitalization.(2) Since both INVEGA SUSTENNA and RISPERDAL
CONSTA are given by a healthcare professional, it offers the
physician a way to monitor patient medication adherence and
intervene when a patient misses a dose. Both products offer
flexibility to physicians and patients, based on their dosing
regimens, thereby offering an important option to those who may
need it. The objective of this study was to show that INVEGA
SUSTENNA was statistically similar (non-inferior) to RISPERDAL
CONSTA, as measured by the Positive and Negative Syndrome Scale
(PANSS). INVEGA SUSTENNA, a once-monthly injectable atypical
antipsychotic, was recently approved in the U.S. for the acute and
maintenance treatment of schizophrenia in adults. RISPERDAL CONSTA,
the first long-acting injectable atypical antipsychotic, was
approved for the treatment of schizophrenia in adults in the U.S.
in 2003, and recently was approved for use as maintenance therapy
in the treatment of Bipolar I Disorder. "Physicians need treatment
options that match the needs of their patients, particularly when
compliance is a significant issue. INVEGA SUSTENNA was non-inferior
to RISPERDAL CONSTA in the treatment of schizophrenia in this
trial, which validates that these are both good options," said
George Simpson, M.D., professor of research at Keck School of
Medicine, University of Southern California and clinical
investigator for the INVEGA SUSTENNA program. "The differences
between the two products, such as the shorter or longer dosing
interval or the need for oral supplementation, provide options for
physicians to decide what will work best for an individual
patient." About the Study The 13-week, randomized, double-blind,
double-dummy trial included 1220 adults with a diagnosis of
schizophrenia and a PANSS total score of 60 to 120. Participants
were randomly assigned to receive INVEGA SUSTENNA (IS) plus oral
placebo or RISPERDAL CONSTA (RC) plus oral risperidone for the
first three weeks. Patients assigned to IS received an initiation
dosing regimen of 234* mg on day 1 and 156 mg on day 8, followed by
once-monthly dosing on day 36 (78 mg or 156 mg) and day 64 (78 mg,
156 mg, or 234 mg). Additional placebo injections were administered
to match RC dosing. Patients assigned to RC received their first
injection on day 8, followed by biweekly injections on day 22, 36,
50, 64 and 78. This was supplemented with placebo injections to
match IS dosing. The 25 mg starting dose of RC could have been
increased up to 37.5 mg starting on day 36 and up to 50 mg on day
64. Patients on RC received mandatory oral risperidone
supplementation from days 1 to 28. Oral supplementation was
optional with subsequent dose increases. The primary endpoint of
the trial was the change in the PANSS total score versus baseline.
Non-inferiority would be concluded by calculation using a 95%
confidence interval (CI) based on a pre-specified change in total
PANSS score. Secondary efficacy measures included change from
baseline for Clinical Global Impression-Severity (CGI-S) and
Personal and Social Performance (PSP) Scale. Results showed similar
improvement in the mean change from baseline to endpoint in PANSS
total score for IS (-18.6) and RC groups (-17.9). Because the lower
limit of the 95% CI exceeded the pre-specified margin of -5, IS was
concluded to be non-inferior to RC. Patients' severity of illness
(CGI-S) and personal and social performance (PSP) improved
similarly in both groups. The overall incidence of
treatment-emergent adverse events (TEAEs) were comparable in the IS
group (57.9%) and in the RC group (52.8%). TEAEs that occurred in
more than 5% in both treatment groups were: insomnia, headache,
somnolence, and injection-site pain. The incidence of
extrapyramidal symptom-related TEAEs was similar for both treatment
groups. The mean increases in body weight at endpoint also were
similar between treatment groups (IS: 1.1 [3.36] kg; RC: 1.0 [3.14]
kg). The study was sponsored by Johnson & Johnson
Pharmaceutical Research and Development, L.L.C. (J&JPRD). In
the U.S., Janssen®, Division of Ortho-McNeil-Janssen
Pharmaceuticals, Inc. markets INVEGA SUSTENNA and RISPERDAL CONSTA.
Visit http://www.invegasustenna.com/ and
http://www.risperdalconsta.com/ for full prescribing information.
INVEGA SUSTENNA was approved in July 2009 in the U.S. for the acute
and maintenance treatment of schizophrenia in adults and utilizes
the NanoCrystal® Technology, which is a proprietary technology
developed by Elan Drug Technologies through Elan Pharma
International Limited and other Elan affiliates. RISPERDAL CONSTA
was approved in 2003 for the treatment of schizophrenia and was
approved in May 2009 for monotherapy and adjunctive therapy in the
maintenance treatment of Bipolar I Disorder in adults. IMPORTANT
SAFETY INFORMATION FOR INVEGA® SUSTENNA(TM) INVEGA® SUSTENNA(TM) is
not approved for the treatment of dementia-related psychosis in
elderly patients. Elderly patients who were given oral
antipsychotics like INVEGA® SUSTENNA(TM) in clinical studies for
psychosis caused by dementia (memory problems) had a higher risk of
death. Neuroleptic Malignant Syndrome (NMS) is a rare, but serious
side effect that could be fatal and has been reported with INVEGA®
SUSTENNA(TM) and similar medicines. Call the doctor right away if
you develop symptoms such as a high fever, rigid muscles, shaking,
confusion, sweating more than usual, increased heart rate or blood
pressure, or muscle pain or weakness. Treatment should be stopped
if you are being treated for NMS. Tardive Dyskinesia (TD) is a
rare, but serious and sometimes permanent side effect reported with
INVEGA® SUSTENNA(TM) and similar medicines. Call your doctor right
away if you start to develop twitching or jerking movements that
you cannot control in your face, tongue, or other parts of your
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
total dose received. This condition can also develop after a short
period of treatment at low doses but this is less common. There is
no known treatment for TD but it may go away partially or
completely if the medicine is stopped. One risk of INVEGA®
SUSTENNA(TM) is that it may change your heart rhythm. This effect
is potentially serious. You should talk to your doctor about any
current or past heart problems. Because these problems could mean
you're having a heart rhythm abnormality, contact your doctor
IMMEDIATELY if you feel faint or feel a change in the way that your
heart beats (palpitations). High blood sugar and diabetes have been
reported with INVEGA® SUSTENNA(TM) and similar medicines. If you
already have diabetes or have risk factors such as being overweight
or a family history of diabetes, blood sugar testing should be done
at the beginning and during the treatment. The complications of
diabetes can be serious and even life-threatening. Call your doctor
if you develop signs of high blood sugar or diabetes, such as being
thirsty all the time, having to urinate or "pass urine" more often
than usual, or feeling weak or hungry. Weight gain has been
observed with INVEGA® SUSTENNA(TM) and other atypical antipsychotic
medications. If you notice that you are gaining weight, please
notify your doctor. Some people may feel faint, dizzy, or may pass
out when they stand up or sit up suddenly. Be careful not to get up
too quickly. It may help if you get up slowly and sit on the edge
of the bed or chair for a few minutes before you stand up. These
symptoms may decrease or go away after your body becomes used to
the medicine. INVEGA® SUSTENNA(TM) and similar medicines have been
associated with decreases in the counts of white cells in
circulating blood. If you have a history of low white blood cell
counts or have unexplained fever or infection, then please contact
your doctor right away. INVEGA® SUSTENNA(TM) and similar medicines
can raise the blood levels of a hormone called prolactin and blood
levels of prolactin remain high with continued use. This may result
in some side effects including missed menstrual periods, leakage of
milk from the breasts, development of breasts in men, or problems
with erection. If you have a prolonged or painful erection lasting
more than 4 hours, seek immediate medical help to avoid long-term
injury. Call your doctor right away if you start thinking about
suicide or wanting to hurt yourself. INVEGA® SUSTENNA(TM) can make
some people feel dizzy, sleepy, or less alert. Until you know how
you are going to respond to INVEGA® SUSTENNA(TM), be careful
driving a car, operating machines, or doing things that require you
to be alert. This medicine may make you more sensitive to heat. You
may have trouble cooling off or be more likely to become
dehydrated. Be careful when you exercise or spend time doing things
that make you warm. Some medications interact with INVEGA®
SUSTENNA(TM). Please inform your healthcare professional of any
medications or supplements that you are taking. INVEGA®
SUSTENNA(TM) 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. Inform your healthcare
professional if you become pregnant or intend to become pregnant
during therapy with INVEGA® SUSTENNA(TM). Do not drink alcohol
while you are taking INVEGA® SUSTENNA(TM). In a study of people
taking INVEGA® SUSTENNA(TM), common side effects in the treatment
of schizophrenia were reactions at the injection site, sleepiness,
dizziness, feeling of inner restlessness, and abnormal muscle
movements, including tremor (shaking), shuffling, uncontrolled
involuntary movements, and abnormal movements of the eyes. This is
not a complete list of all possible side effects. Ask your doctor
or treatment team if you have any questions or want more
information. If you have any questions about INVEGA® SUSTENNA(TM)
or your therapy, talk with your doctor. IMPORTANT SAFETY
INFORMATION FOR RISPERDAL® CONSTA® Elderly Patients with
dementia-related psychosis treated with 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. Cerebrovascular Adverse Events (CAEs):
CAEs, including fatalities, have been reported in elderly patients
with dementia-related psychosis taking oral risperidone in clinical
trials. The incidence of CAEs with risperidone was significantly
higher than with placebo. RISPERDAL® CONSTA® is not approved for
the treatment of patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal
symptom complex, has been reported with the use of antipsychotic
medications, including RISPERDAL® CONSTA®. Clinical manifestations
include muscle rigidity, fever, altered mental status and evidence
of autonomic instability (see full Prescribing Information).
Management should include immediate discontinuation of
antipsychotic drugs and other drugs not essential to concurrent
therapy, intensive symptomatic treatment and medical monitoring,
and treatment of any concomitant serious medical problems. Tardive
Dyskinesia (TD): TD is a syndrome of potentially irreversible,
involuntary, dyskinetic movements that may develop in patients
treated with antipsychotic medications. The risk of developing TD
and the likelihood that dyskinetic movements will become
irreversible are believed to increase with duration of treatment
and total cumulative dose. Elderly patients appeared to be at
increased risk for TD. Prescribing should be consistent with the
need to minimize the risk of TD. The syndrome may remit, partially
or completely, if antipsychotic treatment is withdrawn.
Hyperglycemia and Diabetes: Hyperglycemia, some cases extreme and
associated with ketoacidosis, hyperosmolar coma or death has been
reported in patients treated with atypical antipsychotics (APS),
including RISPERDAL® CONSTA®. Patients starting treatment with APS
who have or are at risk for diabetes should undergo fasting blood
glucose testing at the beginning of and during treatment. Patients
who develop symptoms of hyperglycemia should also undergo fasting
blood glucose testing. Hyperprolactinemia: As with other drugs that
antagonize dopamine D2 receptors, RISPERDAL® CONSTA® elevates
prolactin levels and the elevation persists during chronic
administration. Risperidone is associated with higher levels of
prolactin elevation than other antipsychotic agents. Orthostatic
Hypotension: RISPERDAL® CONSTA® may induce orthostatic hypotension
associated with dizziness, tachycardia, and in some patients,
syncope, especially during the initial dose-titration period.
Monitoring should be considered in patients for whom this may be of
concern. RISPERDAL® CONSTA® should be used with caution in patients
with known cardiovascular disease, and conditions that would
predispose patients to hypotension. Leukopenia, Neutropenia and
Agranulocytosis have been reported with antipsychotics, including
risperidone. Patients with a pre-existing low white blood cell
count (WBC) or a history of leukopenia/neutropenia should have
frequent complete blood cell counts during the first few months of
therapy. At the first sign of a decline in WBC and in the absence
of other causative factors, discontinuation of RISPERDAL® CONSTA®
should be considered. Potential for Cognitive and Motor Impairment:
RISPERDAL® CONSTA® has the potential to impair judgment, thinking,
or motor skills. Patients should be cautioned about operating
hazardous machinery, including motor vehicles, until they are
reasonably certain that RISPERDAL® CONSTA® does not affect them
adversely. Seizures: RISPERDAL® CONSTA® should be used cautiously
in patients with a history of seizures or with conditions that
potentially lower seizure threshold. Dysphagia: Esophageal
dysmotility and aspiration can occur. Use cautiously in patients at
risk for aspiration pneumonia. Priapism has been reported. Severe
priapism may require surgical intervention. Thrombotic
Thrombocytopenic Purpura (TTP) has been reported. Administration:
RISPERDAL® CONSTA® should be injected into the deltoid or gluteal
muscle, and care must be taken to avoid inadvertent injection into
a blood vessel. Suicide: The possibility of suicide attempt is
inherent in schizophrenia or bipolar disorder. Close supervision of
high-risk patients should accompany drug therapy. Increased
sensitivity in patients with Parkinson's disease or those with
dementia with Lewy bodies has been reported. Manifestations and
features are consistent with NMS. Use RISPERDAL® CONSTA® with
caution in patients with conditions and medical conditions that
could affect metabolism or hemodynamic responses (e.g. recent
myocardial infarction or unstable cardiac disease). Maintenance
Treatment: Patients should be periodically reassessed to determine
the need for continued treatment. Commonly Observed Adverse
Reactions for RISPERDAL® CONSTA®: The most common adverse reactions
in clinical trials in patients with schizophrenia (greater than or
equal to 5%) were headache, Parkinsonism, dizziness, akathisia,
fatigue, constipation, dyspepsia, sedation, weight increase, pain
in extremities, and dry mouth. The most common adverse reactions in
clinical trials in patients with bipolar disorder were weight
increased (5% in monotherapy trial) and tremor and Parkinsonism
(> 10% in adjunctive therapy trial). If you have any questions
about RISPERDAL® CONSTA® or your therapy, talk with your doctor.
About Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. 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. About
Janssen 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 has prescription medications for the treatment
of schizophrenia, bipolar mania, and the treatment of symptoms
associated with autistic disorders. Ortho-McNeil-Janssen
Pharmaceuticals, Inc. is a member of the Johnson & Johnson
family of companies. For more information about Janssen, visit
http://www.janssen.com/. *Because doses of paliperidone palmitate
can be expressed both in terms of milligram equivalents (mg eq.) of
the pharmacologically active fraction of paliperidone and in
milligrams of paliperidone palmitate, the doses expressed as 50,
100 and 150 mg eq. equate to 78, 156 and 234 mg respectively, of
paliperidone palmitate. (1)National Institutes of Mental Health Web
site:
http://www.nimh.nih.gov/health/publications/the-numbers-count-mental-disorders
-in-america/index.shtml#Schizophrenia. Accessed November 12, 2009.
(2)Sun SX, Liu GG, Christensen DB, Fu AZ. Review and analysis of
hospitalization costs associated with antipsychotic nonadherence in
the treatment of schizophrenia in the United States. Curr Med Res
Opin. Oct. 2007; 23 (10): 2305-12. DATASOURCE: Janssen(R), Division
of Ortho-McNeil-Janssen Pharmaceuticals, Inc. CONTACT: Media,
Srikant Ramaswami, Office: +1-609-730-2658, Cell: +1-609-647-8195,
or Investors, Louise Mehrotra, +1-732-524-6491 or Lesley Fishman,
+1-732-524-3922, both of Johnson & Johnson Web Site:
http://www.janssen.com/
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