Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and INVEGA(R)
Created by News on 2/6/2009 10:02:44 AM

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) today announced that the company has submitted multiple applications to the U.S. Food and Drug Administration (FDA) which, if approved, would broaden treatment options for patients diagnosed with schizophrenia or schizoaffective disorder.


TITUSVILLE, N.J., Feb. 6 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) today announced that the company has submitted multiple applications to the U.S. Food and Drug Administration (FDA) which, if approved, would broaden treatment options for patients diagnosed with schizophrenia or schizoaffective disorder.

Earlier this week, the company submitted its response to the FDA complete response letter for paliperidone palmitate, received in August 2008. Paliperidone palmitate is an investigational once-monthly atypical antipsychotic injection which, if approved, will be indicated for the acute and maintenance treatment of schizophrenia. 

The company also submitted two supplemental new drug applications (sNDAs) to the FDA requesting approval for the use of INVEGA tablets for the treatment of schizoaffective disorder as monotherapy and for use in combination with antidepressants and/or mood stabilizers. The sNDA submissions include data from two international, 6-week double-blind placebo-controlled studies that evaluated the efficacy and safety of INVEGA in patients with schizoaffective disorder. If approved by the FDA, INVEGA would be the only medication indicated to treat the condition. 

Patients with schizoaffective disorder experience the psychotic symptoms of schizophrenia, such as hallucinations or delusions, as well as mania and/or depression. Because of the similarity in symptoms, schizoaffective disorder is sometimes misdiagnosed as schizophrenia or bipolar disorder. For patients who frequently use mental health services, schizophrenia and schizoaffective disorder may account for approximately 32% and 24% of cases respectively.(i) 

INVEGA, an atypical antipsychotic medication, was first approved in the U.S. in December 2006 and is marketed by Janssen. It is approved for the acute and maintenance treatment of schizophrenia in the U.S. and for the treatment of schizophrenia in the E.U. If approved, Janssen will also market paliperidone palmitate. 

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a subsidiary of Johnson & Johnson, the world's most broadly-based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout Europe, the United States and Asia. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas, including CNS, Internal Medicine and Oncology, to address unmet medical needs worldwide. More information can be found at http://www.jnjpharmarnd.com.

Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is based in Titusville, N.J. and is the only large pharmaceutical company in the U.S. dedicated solely to mental health. It currently markets prescription medications for the treatment of schizophrenia, bipolar mania and the treatment of symptoms associated with autistic disorder. For more information about Janssen, visit http://www.janssen.com.

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. Paliperidone is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with paliperidone 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.

One risk of paliperidone 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 paliperidone. Please inform your healthcare professional of any medications or supplements that you are taking.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with paliperidone 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.

High blood sugar and diabetes have been reported with paliperidone 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 paliperidone. 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.

Paliperidone 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.

People with narrowing or blockage of the gastrointestinal tract (esophagus, stomach or small or large intestine) should talk to their healthcare professional before taking paliperidone.

Some people taking paliperidone 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.

Paliperidone may affect your driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional. Avoid alcohol while on paliperidone.

Paliperidone 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.

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 paliperidone. Caution should be exercised when paliperidone is administered to a nursing woman.

Paliperidone may affect alertness and motor skills; use caution until the effect of paliperidone is known.

Paliperidone 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.

Paliperidone 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.

The most common side effects that occurred with paliperidone were restlessness and extrapyramidal disorder (for example, involuntary movements, tremors and muscle stiffness).

Note Regarding Forward-Looking Statements 

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 the J&JPRD'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 December 30, 2007. 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. J&JPRD does not undertake to update any forward-looking statements as a result of new information or future events or developments.

(1) Kent S, Fogarty M, Yellowlees P. Heavy utilization of inpatient and outpatient services in a public mental health service. Psychiatr Serv. 1995;46:1254-1257.

SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD)

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