Johnson & Johnson Pharmaceutical Research & Development Submits New Drug Application for Paliperidone Palmitate
Titusville, NJ – Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for paliperidone palmitate, an investigational, once-monthly atypical antipsychotic intramuscular injection, for the treatment of schizophrenia and the prevention of recurrence of the symptoms of schizophrenia.
Paliperidone palmitate is a long-acting injectable ester of the active ingredient in INVEGA™1 which utilizes Elan’s NanoCrystal® Technology. Upon approval, paliperidone palmitate will be marketed in the U.S. by Janssen, L.P.
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 2,000,000 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 as by disorganized thinking.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), is headquartered in Raritan, NJ (USA), and has nine sites throughout Europe and the United States. J&JPRD employs approximately 3,500 people and is leveraging drug discovery, drug evaluation, and drug development in a variety of therapeutic areas to address unmet medical needs worldwide. The company’s major therapeutic areas of focus include hematology, oncology, infectious disease, obesity and metabolic disorders, neurology and psychiatry, pain;and women’s health.
Janssen, L.P., based in Titusville, NJ, is a subsidiary of Johnson & Johnson, and 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 www.janssen.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 the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com 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.
Important Safety Information For INVEGA™
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 health care 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. The connection between prolactin levels and side effects is unknown.
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 health care 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 health care 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 health care professional.
Inform your health care 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 health care 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.
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