The U.S. Food and Drug
Administration (FDA) has approved INVEGA(TM) (paliperidone)
Extended-Release Tablets, a new atypical antipsychotic, for the treatment
of schizophrenia. The once-daily oral medication is specifically designed
to deliver paliperidone -- the active ingredient derived from risperidone
-- through the innovative OROS(R) extended-release technology,
demonstrating powerful efficacy and a proven safety and tolerability
profile. INVEGA will be marketed by Janssen, L.P., based in Titusville,
N.J. and will be available in the U.S. in January 2007.
"A well-designed series of worldwide clinical trials involving more than 1,600 patients in 23 countries, have demonstrated that INVEGA provided significant improvement in multiple domains for the symptoms of schizophrenia," said Henry Nasrallah, M.D., Professor of Psychiatry and Neuroscience and Director of the Schizophrenia Research Program at the University of Cincinnati Academic Health Center. "In addition, in these clinical trials, INVEGA demonstrated not only efficacy in treating the symptoms of schizophrenia, but also improvement in the Personal and Social Performance (PSP) Scale, which measures personal and social functioning. At the recommended dose of 6 mg per day, INVEGA had a tolerability profile that was similar to placebo."
Leading national mental health advocacy and patient organizations also recognize the importance of new treatments for schizophrenia.
"We are pleased that innovative delivery technologies are being applied to new treatments for schizophrenia," said Michael J. Fitzpatrick, MSW, Executive Director, National Alliance on Mental Illness (NAMI). "New and efficacious treatment options, like INVEGA, provide significant opportunities for more people with schizophrenia to manage their disease as they work with their treatment teams to live more fulfilling and productive lives."
INVEGA is the first new prescription treatment for schizophrenia to be approved by the FDA since 2003.
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. Personal and Social Performance, another measure of efficacy, as well as safety and tolerability 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 six week clinical trials, INVEGA demonstrated statistically significant symptom improvement versus placebo across all doses investigated. INVEGA was also superior to placebo on the PSP in these trials. INVEGA is the first treatment for schizophrenia to receive FDA approval to include PSP in product labeling.
Treatment-emergent adverse events(i) (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).
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).
INVEGA(TM) (paliperidone) extended-release tablets is indicated for the treatment of schizophrenia.
RISPERDAL(R) (risperidone) Tablets/Oral Solution/Orally Disintegrating Tablets is indicated for the treatment of irritability associated with autistic disorder in children and adolescents (ages 5-16 years), including symptoms of aggression towards others, deliberate self-injury, tantrums, and quickly changing moods.
RISPERDAL(R) (risperidone) is indicated for the treatment of schizophrenia and for the treatment of manic symptoms of acute manic or mixed episodes associated with bipolar I disorder.
IMPORTANT SAFETY INFORMATION FOR INVEGA(TM) AND RISPERDAL(R)
Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. INVEGA (paliperidone), and RISPERDAL (risperidone) are not approved for the treatment of patients with Dementia-Related Psychosis.
Schizophrenia:
The most common side effects that occurred with INVEGA were restlessness and extrapyramidal disorder (for example, involuntary movements, tremors and muscle stiffness). The most common side effects that occurred with RISPERDAL were anxiety, sleepiness, restlessness, tremors, and muscle stiffness; dizziness, constipation, nausea, indigestion, runny nose, rash, and rapid heartbeat.
Bipolar Mania:
The most common side effects that occurred in clinical trials with RISPERDAL, in the treatment of bipolar mania either alone or in combination with a mood stabilizer (lithium or valproate) were: sleepiness, muscle stiffness, restlessness, tremor, indigestion, nausea, abnormal vision, muscle aches, dizziness, runny nose, diarrhea, increased saliva, stomach pain, and urinary incontinence.
Autistic Disorder:
The most common side effects that occurred with RISPERDAL were sleepiness, increased appetite, fatigue, upper respiratory tract infection, increased saliva, constipation, dry mouth, tremor, muscle stiffness, dizziness, repetitive behavior, involuntary movement, rapid heartbeats, confusion, weight increase.
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. Please inform your healthcare professional of any medications or supplements that you are taking.
A rare but serious side effect that has been reported with this kind of medicine, including INVEGA, and RISPERDAL, is known as neuroleptic malignant syndrome (NMS). NMS is characterized by muscle rigidity, fever and can be serious.
You may have heard the term "tardive dyskinesia." These are usually persistent, uncontrollable, slow or jerky facial or body movements that can be caused by all medications of this type. If you have these symptoms, talk to your healthcare professional.
Studies suggest an increased risk of elevated blood sugar-related side effects, and sometimes potentially fatal, in patients treated with this class of medications, including INVEGA and RISPERDAL. Some people may need regular blood sugar testing.
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 or RISPERDAL 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.
You may have heard the term "extrapyramidal symptoms" (EPS). These are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. Some people taking INVEGA or RISPERDAL have these side effects. If you have these symptoms, talk to your healthcare professional.
Some medications may interact with INVEGA or RISPERDAL. Avoid alcohol while on INVEGA or RISPERDAL.
Inform your healthcare professional if you are pregnant or if you are planning to get pregnant while taking INVEGA or RISPERDAL. Do not breast-feed if you are taking INVEGA or RISPERDAL.
INVEGA or RISPERDAL may affect your driving ability, therefore, do not drive or operate machines before talking to your healthcare professional.
NVEGA and RISPERDAL may affect alertness and motor skills; use caution until the effect of INVEGA and RISPERDAL 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.
Please see full important U.S. prescribing information for INVEGA and RISPERDAL at http://www.janssen.com.
Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness. In the United States, there are currently two million people with schizophrenia, with men and women affected equally. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well by disorganized thinking.
The FDA is the first regulatory agency worldwide to approve INVEGA. Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) submitted a New Drug Application to the FDA in November 2005. In May 2006, Janssen-Cilag, NV submitted a Marketing Authorization Application to European health authorities seeking approval to market the medication for the treatment of schizophrenia and approvals will be sought worldwide.
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 http://www.janssen.com, and for more information on INVEGA, visit http://www.INVEGA.com.
J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Europe and the U.S. The company is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.
INVEGA delivers paliperidone via the OROS extended-release technology, which was developed by ALZA Corporation. OROS technology employs osmosis to provide precise, controlled drug delivery. For more information on OROS technology, please visit: http://www.alza.com.
Web sites: http://www.janssen.com; http://www.invega.com; http://www.alza.com; http://www.jnj.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 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 January 1, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
i) 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, L.P.
http://www.janssen.com
"A well-designed series of worldwide clinical trials involving more than 1,600 patients in 23 countries, have demonstrated that INVEGA provided significant improvement in multiple domains for the symptoms of schizophrenia," said Henry Nasrallah, M.D., Professor of Psychiatry and Neuroscience and Director of the Schizophrenia Research Program at the University of Cincinnati Academic Health Center. "In addition, in these clinical trials, INVEGA demonstrated not only efficacy in treating the symptoms of schizophrenia, but also improvement in the Personal and Social Performance (PSP) Scale, which measures personal and social functioning. At the recommended dose of 6 mg per day, INVEGA had a tolerability profile that was similar to placebo."
Leading national mental health advocacy and patient organizations also recognize the importance of new treatments for schizophrenia.
"We are pleased that innovative delivery technologies are being applied to new treatments for schizophrenia," said Michael J. Fitzpatrick, MSW, Executive Director, National Alliance on Mental Illness (NAMI). "New and efficacious treatment options, like INVEGA, provide significant opportunities for more people with schizophrenia to manage their disease as they work with their treatment teams to live more fulfilling and productive lives."
INVEGA is the first new prescription treatment for schizophrenia to be approved by the FDA since 2003.
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. Personal and Social Performance, another measure of efficacy, as well as safety and tolerability 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 six week clinical trials, INVEGA demonstrated statistically significant symptom improvement versus placebo across all doses investigated. INVEGA was also superior to placebo on the PSP in these trials. INVEGA is the first treatment for schizophrenia to receive FDA approval to include PSP in product labeling.
Treatment-emergent adverse events(i) (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).
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).
INVEGA(TM) (paliperidone) extended-release tablets is indicated for the treatment of schizophrenia.
RISPERDAL(R) (risperidone) Tablets/Oral Solution/Orally Disintegrating Tablets is indicated for the treatment of irritability associated with autistic disorder in children and adolescents (ages 5-16 years), including symptoms of aggression towards others, deliberate self-injury, tantrums, and quickly changing moods.
RISPERDAL(R) (risperidone) is indicated for the treatment of schizophrenia and for the treatment of manic symptoms of acute manic or mixed episodes associated with bipolar I disorder.
IMPORTANT SAFETY INFORMATION FOR INVEGA(TM) AND RISPERDAL(R)
Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. INVEGA (paliperidone), and RISPERDAL (risperidone) are not approved for the treatment of patients with Dementia-Related Psychosis.
Schizophrenia:
The most common side effects that occurred with INVEGA were restlessness and extrapyramidal disorder (for example, involuntary movements, tremors and muscle stiffness). The most common side effects that occurred with RISPERDAL were anxiety, sleepiness, restlessness, tremors, and muscle stiffness; dizziness, constipation, nausea, indigestion, runny nose, rash, and rapid heartbeat.
Bipolar Mania:
The most common side effects that occurred in clinical trials with RISPERDAL, in the treatment of bipolar mania either alone or in combination with a mood stabilizer (lithium or valproate) were: sleepiness, muscle stiffness, restlessness, tremor, indigestion, nausea, abnormal vision, muscle aches, dizziness, runny nose, diarrhea, increased saliva, stomach pain, and urinary incontinence.
Autistic Disorder:
The most common side effects that occurred with RISPERDAL were sleepiness, increased appetite, fatigue, upper respiratory tract infection, increased saliva, constipation, dry mouth, tremor, muscle stiffness, dizziness, repetitive behavior, involuntary movement, rapid heartbeats, confusion, weight increase.
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. Please inform your healthcare professional of any medications or supplements that you are taking.
A rare but serious side effect that has been reported with this kind of medicine, including INVEGA, and RISPERDAL, is known as neuroleptic malignant syndrome (NMS). NMS is characterized by muscle rigidity, fever and can be serious.
You may have heard the term "tardive dyskinesia." These are usually persistent, uncontrollable, slow or jerky facial or body movements that can be caused by all medications of this type. If you have these symptoms, talk to your healthcare professional.
Studies suggest an increased risk of elevated blood sugar-related side effects, and sometimes potentially fatal, in patients treated with this class of medications, including INVEGA and RISPERDAL. Some people may need regular blood sugar testing.
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 or RISPERDAL 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.
You may have heard the term "extrapyramidal symptoms" (EPS). These are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. Some people taking INVEGA or RISPERDAL have these side effects. If you have these symptoms, talk to your healthcare professional.
Some medications may interact with INVEGA or RISPERDAL. Avoid alcohol while on INVEGA or RISPERDAL.
Inform your healthcare professional if you are pregnant or if you are planning to get pregnant while taking INVEGA or RISPERDAL. Do not breast-feed if you are taking INVEGA or RISPERDAL.
INVEGA or RISPERDAL may affect your driving ability, therefore, do not drive or operate machines before talking to your healthcare professional.
NVEGA and RISPERDAL may affect alertness and motor skills; use caution until the effect of INVEGA and RISPERDAL 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.
Please see full important U.S. prescribing information for INVEGA and RISPERDAL at http://www.janssen.com.
Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness. In the United States, there are currently two million people with schizophrenia, with men and women affected equally. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well by disorganized thinking.
The FDA is the first regulatory agency worldwide to approve INVEGA. Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) submitted a New Drug Application to the FDA in November 2005. In May 2006, Janssen-Cilag, NV submitted a Marketing Authorization Application to European health authorities seeking approval to market the medication for the treatment of schizophrenia and approvals will be sought worldwide.
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 http://www.janssen.com, and for more information on INVEGA, visit http://www.INVEGA.com.
J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Europe and the U.S. The company is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.
INVEGA delivers paliperidone via the OROS extended-release technology, which was developed by ALZA Corporation. OROS technology employs osmosis to provide precise, controlled drug delivery. For more information on OROS technology, please visit: http://www.alza.com.
Web sites: http://www.janssen.com; http://www.invega.com; http://www.alza.com; http://www.jnj.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 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 January 1, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
i) 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, L.P.
http://www.janssen.com
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