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December 20, 2006
FDA Approves J&J Antipsychotic Named "Invega"
Read more... Schizophrenia Medications
The Food and Drug Administration approved a new schizophrenia drug from Johnson & Johnson called "Invega" this week.
The Wall Street Journal stated that the new once-a-day pill "is derived from Risperdal, another drug used to treat schizophrenia and other mental illnesses, which is Johnson & Johnson's best-selling product, with $3.55 billion in revenue in 2005. Generic Risperdal, or risperidone, could be on the market as early as 2008."
Invega will be available in US pharmacies next month, Johnson and Johnson said. A schedule for availability in other countries was not provided by Johnson and Johnson. A J&J company spokesman suggested that the new drug "will be priced competitively with other currently available atypical antipsychotics." It has been reported in the past that the most popular doses of Risperdal cost about $4 a pill.
Invega was studied in 1,665 patients in three, six-week clinical trials that compared the medication to a placebo, or a fake pill. The FDA said that in the three studies, which used doses ranging from three milligrams to 15 milligrams daily, the effectiveness of Invega at relieving symptoms of schizophrenia was better than a placebo. The recommended dosage range for Invega is three to 12 milligrams a day. Side effects include restlessness, movement disorders, rapid heart beat and sleepiness.
The FDA said Invega's effectiveness hasn't been studied in placebo-controlled clinical trials for more than six weeks, and patients using the drug on a long-term basis need to be re-evaluated by a physician.
Additional Reading: FDA OKs J&J's next-generation schizophrenia pill (Scientific American)
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.
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.
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.
INVEGA 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/.
Posted by szadmin at December 20, 2006 09:14 PM
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