The European Commission
granted marketing authorization for INVEGA(TM) (paliperidone prolonged
release tablets), an atypical antipsychotic medication for the treatment of
schizophrenia. This once-daily medication is specifically designed to
deliver paliperidone - the active ingredient in INVEGA - through the
innovative osmotic delivery system (OROS(R)). In clinical trials, INVEGA
demonstrated significant efficacy as compared to placebo in helping many
patients control the symptoms of schizophrenia, and it was generally well
tolerated.
INVEGA (paliperidone prolonged release tablets) will be marketed in
Europe by Janssen-Cilag. In the U.S., this product is marketed by Janssen,
L.P. as INVEGA (paliperidone) Extended-Release Tablets. This approval
represents another important milestone in the company's long-standing
commitment to develop new treatment options for serious mental illnesses.
INVEGA is the first and only treatment for schizophrenia to receive
marketing authorization in the EU that uses the osmotic delivery system
(OROS(R)).
The decision of the European Medicines Agency to grant marketing
authorization for INVEGA in Europe is based on efficacy and safety results
of an extensive clinical development program that included: three six-week,
placebo controlled clinical studies involving more than 1,600 patients with
acute schizophrenia in 23 countries,(i) a longer-term (up to 40 weeks)
double blind, placebo controlled study in 207 randomized patients(ii)
examining time to relapse, and another double blind, placebo controlled
study assessing safety and tolerability in 114 elderly patients suffering
from schizophrenia.(iii)
The primary measure of efficacy was the Positive and Negative Syndrome
Scale (PANSS), a tool commonly used in schizophrenia research that measures
the severity of positive and negative symptoms and general psychopathology.
The Personal and Social Performance Scale (PSP), a measure of functional
improvement, as well as safety and tolerability assessments, were also
included in the trials that supported the approval of INVEGA. The
recommended dose of INVEGA is 6 mg per day, with a dose range of 3 mg to 12
mg per day depending on patient need.
Key findings of the program include:
-- In three six-week clinical trials, INVEGA demonstrated statistically
significant symptom improvement on the PANSS versus placebo across all
doses investigated. INVEGA was also superior to placebo on the PSP in
these trials. In a chronic treatment trial, adult patients with
schizophrenia who were treated with INVEGA showed a significantly
longer time to relapse compared to placebo.
-- From the three six-week clinical trials, treatment-emergent adverse
events(iv) (TEAEs) reported in 5% or more of subjects treated with
INVEGA and at least twice the placebo rate for at least one dose
included: akathisia (i.e. restlessness) and extrapyramidal disorder
(e.g. involuntary movements, tremors or muscle stiffness).
-- In the three six-week clinical trials, discontinuation rates due to
TEAEs for all INVEGA dose groups were low and comparable to placebo (5%
for placebo and for INVEGA: 2% for 3 mg, 6% for 6 mg, 4% for 9 mg, 5%
for 12 mg).
Worldwide, it is estimated that 1 person in every 100 develops
schizophrenia, one of the most serious types of mental illness. In the
United States, there are currently 2,000,000 people with schizophrenia,
with men and women affected in nearly equal numbers. The disease is marked
by positive symptoms (hallucinations and delusions) and negative symptoms
(depression, blunted emotions, and social withdrawal), as well as by
disorganized thinking.
INVEGA was approved in the U.S. in December 2006, and was the first new
prescription treatment for schizophrenia to be approved by the U.S. FDA
since 2003. In April 2007, INVEGA was also approved by the FDA for the
long-term maintenance treatment of schizophrenia. INVEGA was discovered and
jointly developed by ALZA Corporation and Johnson & Johnson Pharmaceutical
Research and Development, LLC.
Janssen, L.P., 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, L.P., visit janssen;
for more information on INVEGA, visit INVEGA.
INVEGA(TM) (paliperidone) extended-release tablets is indicated for the
treatment of schizophrenia.
IMPORTANT SAFETY INFORMATION FOR INVEGA(TM)
Elderly Patients with dementia-related psychosis treated with atypical
antipsychotic drugs are at an increased risk of death compared to placebo.
INVEGA (paliperidone) is not approved for the treatment of patients with
dementia-related psychosis.
The most common side effects that occurred with INVEGA were
restlessness and extrapyramidal disorder (for example: involuntary
movements, tremors and muscle stiffness).
One risk of INVEGA is that it may change your heart rhythm. This effect
is potentially serious, and you should talk to your doctor about any
current or past heart problems. Some medications interact with INVEGA.
Please inform your healthcare professional of any medications or
supplements that you are taking.
Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal
side effect reported with INVEGA 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 INVEGA 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.
INVEGA 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.
INVEGA 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. There is no known connection between
prolactin levels and side effects.
High blood sugar and diabetes have been reported with INVEGA 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 INVEGA. 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.
People with narrowing or blockage of the gastrointestinal tract
(esophagus, stomach or small or large intestine) should talk to their
healthcare professional before taking INVEGA.
Some people taking INVEGA 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 may be
reduced or it may go away over time.
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 are pregnant or if you are
planning to get pregnant while taking INVEGA. Do not breast-feed if you are
taking INVEGA.
INVEGA may affect your driving ability; therefore, do not drive or
operate machines before talking to your healthcare professional. Avoid
alcohol while on INVEGA.
INVEGA may affect alertness and motor skills; use caution until the
effect of INVEGA is known.
INVEGA 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.
INVEGA should be swallowed whole. Tablets should not be chewed,
divided, or crushed. Do not be worried if you see something that looks like
a tablet in your stool. This is what is left of the tablet after all the
medicine has been released.
References
i) Meltzer H et al. Efficacy and Tolerability of Oral Paliperidone
Extended-Release Tablets in the Treatment of Acute Schizophrenia: Pooled
Data from Three 6-Week Placebo Controlled Studies. Poster presented at USP
& MHC 2006, 16-19 November 2006 , New Orleans, NY, USA
ii) Kramer M et al. Paliperidone extended-release tablets for prevention
of symptom recurrence in patients with schizophrenia: a randomized, double-
blind, placebo-controlled study. Journal of Clinical Psychopharmacology.
27(1):6-14, 2007 Feb
iii) Tzimos A et al. 6-Week Placebo-Controlled Study of the Safety and
Tolerability of Flexible Doses of Oral Paliperidone Extended-Release
Tablets in the Treatment of Schizophrenia in Elderly Patients. Poster
presented at USP & MHC 2006, 16-19 November 2006 , New Orleans, NY, USA
iv) A treatment-emergent adverse event is defined as any event not
present prior to the initiation of the treatments or any event already
present that worsens in intensity or frequency following exposure to the
treatments.
Janssen
janssen
View drug information on Invega.