INVEGA(R) Approved as First and Only Antipsychotic Treatment for Schizoaffective Disorder in the European Union

By Janssen, PRNE
Monday, January 3, 2011

BEERSE, Belgium, January 4, 2011 - Janssen-Cilag International NV today announced that it has received
approval from the European Commission for the first antipsychotic treatment
for schizoaffective disorder. INVEGA(R) (paliperidone ER) is now indicated
for the treatment of psychotic or manic symptoms of schizoaffective disorder.
Effect on depressive symptoms has not been demonstrated.

The decision follows a positive recommendation by the Committee for
Medicinal Products for Human Use (CHMP), the scientific committee of the
European Medicines Agency. The CHMP concluded that the new therapeutic
indication for INVEGA(R) brings significant clinical benefit in comparison
with existing therapies.

Schizoaffective disorder is a chronic and disabling mental illness,
characterised by both symptoms of schizophrenia and a major mood disorder,
such as bipolar disorder or depression. Patients may experience the clinical
symptoms of schizophrenia, such as hallucinations or delusions, as well as
symptoms of mania and/or depression. Schizoaffective disorder is thought to
be one-third as common as schizophrenia, with an estimated prevalence of
approximately 1 in every 300 people[1]. Schizoaffective disorder may also
account for up to one-quarter of admissions to inpatient mental health

"Janssen is committed to helping improve the lives of people with serious
mental illness and has a long history of developing innovative medicines in
this field," said Dr Christophe Tessier*, Medical Affairs Director,
Psychiatry, Janssen. "We are proud to be able to bring to market the first
antipsychotic treatment for schizoaffective disorder in Europe - a difficult
to diagnose condition associated with a high rate of hospitalisations and
suicidal behaviour."

The approval is based on two international, randomised, double-blind,
placebo-controlled 6-week studies in patients diagnosed with schizoaffective
disorder[3,4]. In the first six-week study, patients (n=316) received one of
two daily doses of INVEGA(R): 6 mg with the option to reduce to 3 mg, or 12
mg with the option to reduce to 9 mg, or placebo[3]. In the second study,
patients (n=311) were randomised to flexible doses of INVEGA(R) (3-12 mg once
daily) either as monotherapy or in addition to treatment with mood
stabilisers and/or antidepressants or placebo[4].

Efficacy was evaluated by the change in patients' symptoms after six
weeks as measured by the positive and negative syndrome scale (PANSS). The
results for INVEGA(R) in both studies were superior to placebo. In the first
study, patients receiving the higher dose of INVEGA(R) had a significant
decrease in their symptom score compared with those receiving placebo (-32.4
compared with -24.1, p=0.003)[3]. The lower dose of INVEGA(R) was not
significantly different from placebo (p=0.187). In the second study, the mean
decrease in symptom score was -20.0 in the INVEGA(R) group and -10.8 in the
placebo group 3 (p=0.0001)[4]. Furthermore, among patients with prominent
manic symptoms as measured by the Young Mania Rating Scale (YMRS baseline
score greater than or equal to 16) INVEGA(R) resulted in significant
improvements in manic symptomatology compared to placebo.

"These two studies combined represent the largest set of prospective data
in patients with schizoaffective disorder and provide important insights into
this understudied disease", said Dr Carla M. Canuso**, Johnson & Johnson
Pharmaceutical Research and Development, LLC, Titusville, NJ and lead
investigator of the two studies. "INVEGA(R) was proven to be effective both
as a monotherapy and as an adjunctive therapy in reducing psychotic and manic
symptoms and provides a welcome treatment option for this debilitating

About schizoaffective disorder

Schizoaffective disorder usually develops in early adulthood and is more
common in women. It can affect all aspects of a person's daily life,
including work, personal relationships and the ability to take care of
oneself. Patients with schizoaffective disorder have a high rate of
hospitalisations and a higher rate of co-morbid substance abuse than patients
with schizophrenia[5,6]. In addition, patients with schizoaffective disorder
appear to be at greater risk of suicidal behaviour than patients with
schizophrenia and mood disorders[5,6].

About INVEGA(R) (paliperidone ER)

INVEGA(R) (paliperidone ER), an atypical antipsychotic medication, was
first approved in Europe in June 2007 for the treatment of schizophrenia.
INVEGA(R) is a novel molecule (paliperidone) delivered via an osmotic drug
delivery system (OROS(R)) which provides a steady, smooth release of
medication over 24 hours. This reduces the peaks and troughs in drug plasma
levels associated with immediate release oral formulations and leads to a low
potential for increased side effects as well as ensuring consistent efficacy.
INVEGA(R) is the first antipsychotic medication to have significantly
improved personal and social performance recognised in its Summary of Product
Characteristics (SPC). Further information about INVEGA(R) can be found at:

(Due to the length of this URL, it may be necessary to copy and paste
this hyperlink into your Internet browser's URL address field. Remove the
space if one exists.)

About Janssen

Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to
addressing and solving the most important unmet medical needs of our time,
including oncology (e.g. multiple myeloma and prostate cancer), immunology
(e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain),
infectious disease (e.g. HIV/AIDS, Hepatitis C and tuberculosis), and
cardiovascular and metabolic diseases (e.g. diabetes). Driven by our
commitment to patients, we develop sustainable, integrated healthcare
solutions by working side-by-side with healthcare stakeholders, based on
partnerships of trust and transparency. More information can be found at


1. Perela J et al. Lifetime Prevalence of Psychotic and Bipolar I
Disorders in a General Population. Arch Gen Psychiatry. 2007;64, 19 - 28.

2. Kent S, Fogarty M, Yellowlees P. (1995). Heavy Utilization of
Inpatient and Outpatient Services in a Public Mental Health Service.
Psychiatr Serv. 1995;46, 12, 1254 - 1257.

3. Canuso C et al. A Randomized, Double-Blind, Placebo-Controlled Study
of 2 Dose Ranges of Paliperidone Extended-Release in the Treatment of
Subjects With Schizoaffective Disorder. J Clin Psychiatry. 2010;71, 5, 587 -

4. Canuso C et al. Paliperidone Extended-Release in Schizoaffective
Disorder: A Randomized, Controlled Study Comparing a Flexible Dose With
Placebo in Patients Treated With and Without Antidepressants and/or Mood
Stabilizers. J Clin Psychopharmacology. 2010;30, 5, 487 - 495.

5. Cheniaux E, Landeira-Fernandez J, Lessa Telles L, et al. Does
schizoaffective disorder really exist? A systematic review of the studies
that compared schizoaffective disorder with schizophrenia or mood disorders.
J Affect Disord. 2008;106, 3, 209-217.

6. Potkin SG, Alphs L, Hsu C, et al. InterSePT Study Group. Predicting
suicidal risk in schizophrenic and schizoaffective patients in a prospective
two-year trial. Biol Psychiatry. 2003;54, 4, 444-452.

* Dr Christophe Tessier is a full time employee of Janssen, EMEA

** Dr Carla M. Canuso is a full time employee of Johnson & Johnson
Pharmaceutical Research and Development, LLC, Titusville, NJ

For further information please contact: Sue Silk, Janssen, Tel: +44(0)1494-553955, Email: ssilk at; Joanna Smith, Resolute Communications, Tel: +44(0)207-357-8187, Email: joanna.smith at; Investor Contacts: Louise Mehrotra +1-732-524-6491; Stan Panasewicz, +1-732-524-2524

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