INVEGA(R) SUSTENNA(TM) is the First Once-Monthly Atypical
Antipsychotic Approved for Schizophrenia in the United States
TITUSVILLE, N.J., Aug. 3 /PRNewswire/ -- The U.S. Food and Drug
Administration approved INVEGA SUSTENNA(TM) (paliperidone
palmitate) extended-release injectable suspension for the acute and
maintenance treatment of schizophrenia in adults on Friday, July
31, 2009. It is the first once-monthly, long-acting, injectable
atypical antipsychotic approved in the U.S. for this use. Janssen ,
Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, will market
INVEGA SUSTENNA(TM) in the U.S. To view the Multimedia News
Release, go to: http://www.prnewswire.com/mnr/janssen/39116/ 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. While there is no cure for schizophrenia, the
symptoms and the risk of relapse (an exacerbation of symptoms) can
be managed in most patients with appropriate treatment that
includes continuous, long-term therapy with antipsychotic
medications.(1) Unfortunately, 80 percent of patients with
schizophrenia experience at least one relapse within five years of
diagnosis(2), and the risk for relapse in patients can
substantially increase as a result of non-adherence.(2) Research
shows that many patients treated with an oral atypical
antipsychotic miss taking medication for about one-third of the
year (110 days).(3) Therefore, it is critical for healthcare
professionals to ensure that patients are following their treatment
plans in order to help reduce the risk of relapse, because
prognosis and outcome can progressively decline with each
successive relapse.(4) "Inconsistent compliance with medications is
arguably one of the single greatest impediments to managing the
symptoms of schizophrenia and delaying the time to relapse," said
Henry A. Nasrallah, M.D., a clinical investigator who worked on the
INVEGA SUSTENNA(TM) clinical trials, and a Professor of Psychiatry
and Neuroscience and Director of the Schizophrenia Research Program
at the University of Cincinnati College of Medicine. "The approval
of once-monthly INVEGA SUSTENNA(TM) will provide healthcare
professionals with a treatment option that is, at the same time, a
definitive monitoring tool for uninterrupted medication compliance,
which may help optimize clinical outcomes in schizophrenia." The
approval is based on four acute symptom control studies and a
longer-term maintenance study that compared INVEGA SUSTENNA(TM) to
placebo. INVEGA SUSTENNA(TM) was superior to placebo in improving
positive and negative syndrome scale (PANSS) total scores in the
acute treatment trials and significantly delayed time to relapse
vs. placebo in the longer-term maintenance study. The most recent
acute symptom control study was a multi-center, randomized,
placebo-controlled, double-blind, parallel-group study (n=636). All
patients received a dose of 234 mg on Day 1 in the deltoid muscle.
From Day 8 and monthly thereafter, patients were assigned to one of
three fixed doses of INVEGA SUSTENNA(TM) for a period of 13 weeks.
The primary endpoint of this study was the change in total PANSS
score from baseline to endpoint. Each of the three additional acute
treatment studies involving INVEGA SUSTENNA(TM) met its primary
endpoint of significantly improving PANSS scores relative to
placebo. The efficacy of INVEGA SUSTENNA(TM) in maintaining
symptomatic control in schizophrenia was evaluated in a
multicenter, randomized, double-blind, placebo-controlled,
parallel-group study (n=410). Time-to-first relapse -- the primary
endpoint of the study -- was significantly longer for patients
receiving INVEGA SUSTENNA(TM) compared with placebo-treated
patients (P < 0.0001). During the double-blind phase of the
study, fewer patients treated with INVEGA SUSTENNA(TM) experienced
a relapse (10% [n=15/156]) compared with those in the placebo group
(34% [n=53/156]). Because maintenance of efficacy was demonstrated,
the trial was ended early. Patients on INVEGA SUSTENNA(TM)
experienced a significant delay in time to relapse compared to
placebo. Patients on placebo had a 3.6 fold higher incidence of
experiencing relapse versus INVEGA SUSTENNA(TM). As such, INVEGA
SUSTENNA(TM) has the potential to be of tremendous benefit for
physicians, caregivers and patients. In clinical trials, the most
common adverse events (incidence greater than or equal to 5% and
occurring at least twice as often as placebo) were injection site
reactions, somnolence/sedation, dizziness, akathisia and
extrapyramidal disorder. "INVEGA SUSTENNA(TM) provides healthcare
professionals the opportunity to rethink their overall approach to
how they treat schizophrenia by using long-acting therapies," said
Husseini Manji, M.D., F.R.C.P.C., Global Therapeutic Area Head,
Neuroscience, Johnson & Johnson Pharmaceutical Research &
Development. "The approval of INVEGA SUSTENNA(TM) demonstrates our
commitment to providing valuable novel therapies for schizophrenia.
INVEGA SUSTENNA(TM) has a demonstrated safety profile that can help
healthcare professionals address the issue of medication adherence
and can also help many patients delay the time to relapse." Visit
http://www.invegasustenna.com/ for full prescribing information.
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. 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). 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. 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. 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. 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) 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.
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. Call your doctor
right away if you start thinking about suicide or wanting to hurt
yourself. 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. About INVEGA SUSTENNA(TM) INVEGA SUSTENNA(TM) is approved
for the acute and maintenance treatment of schizophrenia. It is the
first once-monthly, long-acting, injectable atypical antipsychotic
approved for this use in the U.S. INVEGA SUSTENNA(TM) is available
in milligrams (mg) of paliperidone palmitate in dose strengths of
39 mg, 78 mg, 117 mg, 156 mg and 234 mg. Please be aware that
clinical trial data presented at medical meetings were often
reported as milligram equivalents (mg eq.) to paliperidone. Each
dose of paliperidone palmitate is equivalent to a specific dose of
paliperidone (39 mg, 78 mg, 117 mg, 156 mg and 234 mg of
paliperidone palmitate is equivalent to 25 mg, 50 mg, 75 mg, 100 mg
and 150 mg of paliperidone, respectively). The pre-filled syringes
require no reconstitution or refrigeration. Patients initiate
treatment with two injections administered in the deltoid muscle
one week apart (Day 1 at 234 mg and Day 8 at 156 mg), followed by
injections every month thereafter administered in either the
deltoid or gluteal muscle. INVEGA SUSTENNA(TM) was developed
utilizing Elan Drug Technologies' proprietary NanoCrystal
Technology. Using this technology increases the rate of dissolution
and enables the formulation of an aqueous suspension for
once-monthly intramuscular administration. INVEGA SUSTENNA(TM) is
manufactured by Janssen, Division of Ortho-McNeil-Janssen
Pharmaceuticals, Inc, in the U.S. About J&JPRD INVEGA
SUSTENNA(TM) was developed by Johnson & Johnson Pharmaceutical
Research & Development, L.L.C. (J&JPRD), a member of the
Johnson & Johnson family of companies, the world's most
broadly-based producer of health care products. J&JPRD is
headquartered in Raritan, N.J., and has facilities throughout
Europe, the United States, and Asia. J&JPRD is leveraging drug
discovery and drug development in a variety of therapeutic areas,
including CNS, Internal Medicine, and Oncology, to address unmet
medical needs worldwide. More information can be found at
http://www.jnjpharmarnd.com/. 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 markets
prescription medications for the treatment of schizophrenia,
bipolar mania, schizoaffective disorder, 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/. About NanoCrystal Technology and Elan Drug
Technologies INVEGA SUSTENNA(TM) utilizes the NanoCrystal
Technology, which is a proprietary technology developed by Elan
Drug Technologies through Elan Pharma International Limited and
other Elan affiliates. NanoCrystal Technology is a registered
trademark of Elan Pharma International Limited, Ireland, a
subsidiary of Elan Corporation plc (NYSE:ELN). The NanoCrystal
Technology is a proven, robust, drug optimization technology,
enabling solubility for many poorly water-soluble compounds. More
information is available at http://www.elandrugtechnologies.com/.
(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 Janssen and/or 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
Johnson & Johnson's Annual Report on Form 10-K for the fiscal
year ended December 28, 2008. Copies of this Form 10-K, as well as
subsequent filings, are available online at http://www.sec.gov/,
http://www.jnj.com/ or on request from Johnson & Johnson.
Neither Janssen nor Johnson & Johnson undertake to update any
forward-looking statements as a result of new information or future
events or developments.) Contacts: Media Srikant Ramaswami: Office:
(609) 730-2658 Cell: (609) 647-8195 Investors Louise Mehrotra:
(732) 524-6491 Johnson & Johnson Lesley Fishman: (732) 524-3922
Johnson & Johnson References (1) Keith SJ, Kanke JM. Journal of
Clinical Psychiatry 2003; 64:1308-15 (2) Robinson D, Woerner MG,
Alvir JM, et al. Predictors of relapse following response from a
first episode of schizophrenia or Schizoaffective Disorder.
Archives of General Psychiatry 1999; 56:241-247 (3) Kane, JM.
Review of Treatments That Can Ameliorate Nonadherence in Patients
With Schizophrenia. Journal of Clinical Psychiatry 2006; 67(suppl
5):9-14 (4) Wyatt, RJ. Neuroleptics and the natural course of
schizophrenia. Schizophrenia Bulletin 1991; 17:325-51
http://www.prnewswire.com/mnr/janssen/39116DATASOURCE: Janssen,
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;
Lesley Fishman: +1-732-524-3922, both of Johnson & Johnson Web
Site: http://www.janssen.com/
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