Navigation Links
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and INVEGA(R)

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

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


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, 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)
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Johnson & Johnson to Provide Webcast Presentation of Tapentadol Phase 3 Clinical Data Presented at American Pain Societys Annual Meeting
2. Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline
3. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
4. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
5. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
6. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
7. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
8. ( Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
9. Par Pharmaceutical Begins Shipment of Additional Dosage Strength of Generic TOPROL-XL(R)
10. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
11. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
Post Your Comments:
(Date:12/1/2015)... 1, 2015 --> ... report "Nucleic Acid Labeling Market by Product (Reagents & ... Primer, In Vitro Transcription, Reverse Transcription, End Labeling), by ... The global market is expected to reach USD 1,925.7 ... growing at a CAGR of 8.65%. Browse ...
(Date:12/1/2015)... Russia has always been a country of choice for ... Europe in 2015 were tested in phase II-III ... has always been a country of choice for global multi-center phase ... in 2015 were tested in phase II-III clinical trials ... always been a country of choice for global multi-center phase III clinical ...
(Date:12/1/2015)... Dec. 1, 2015 Relmada Therapeutics, Inc. (OTCQB: RLMD), ... chronic pain, announced today that the company will present at ... December 1-3 at the Luxe Sunset Boulevard Hotel in ... CEO of Relmada Therapeutics, will present on Thursday, December 3, ... . Please register at least 10 minutes prior ...
Breaking Medicine Technology:
(Date:12/1/2015)... , ... December 01, 2015 , ... According to an ... groups has filed a discrimination claim against the U.S. Department of Health and Human ... Affordable Care Act (ACA) plans are breaking the clause in the law prohibiting the ...
(Date:12/1/2015)... ... December 01, 2015 , ... Califia Farms , one ... its iconic bottle has won top honors in Beverage World Magazine’s Global Packaging Design ... announced that it has been selected as a 2015 U.S.A. Taste Champion in the ...
(Date:12/1/2015)... ... , ... Growth in medical payments per workers’ compensation claim in Louisiana slowed ... nonhospital care, according to a recent study by the Workers Compensation Research Institute (WCRI). ... medical payments per claim with more than seven days of lost time continued to ...
(Date:12/1/2015)... ... December 01, 2015 , ... CloudLIMS today announced ... Bridge Business Awards under the New Products and Services category for its innovative ... sample management software that helps labs organize data and track samples with ...
(Date:12/1/2015)... ... December 01, 2015 , ... Diabetic foot wounds ... Podiatrists are well aware that psychology-based patient non-compliance (disobedience of a health care ... to diseases of the diabetic foot. The American Board of Multiple Specialties ...
Breaking Medicine News(10 mins):