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Janssen, L.P. INVEGA(TM) Significantly Reduced Symptoms of Schizophrenia Compared to SEROQUEL(R) in Acutely Ill, Hospitalized Patients


10/15/2007 9:25:54 AM

ORLANDO, Fla., Oct. 13 /PRNewswire/ -- Acutely ill, hospitalized patients with schizophrenia showed significant improvement in symptoms after taking INVEGA(TM) (paliperidone) Extended-Release Tablets as compared to SEROQUEL(R)(a) (quetiapine) and placebo. Symptom improvement was observed with INVEGA as early as five days into therapy and continued through the end of the two-week study period, according to preliminary data presented today at the 20th Annual U.S. Psychiatric and Mental Health Congress in Orlando, Florida (1).

The primary endpoint was the change in the total Positive and Negative Syndrome Scale (PANSS)(b) score over the first two weeks of the study. The results showed that INVEGA achieved a significant reduction of symptoms of acutely ill, hospitalized patients, compared to SEROQUEL and placebo after two weeks of treatment (p < less than > 0.001).

"In the treatment of patients with an acute exacerbation of schizophrenia, it is important to explore medications that have the potential to achieve effective, acute symptom control. Schizophrenia patients may take two to four weeks to respond fully to treatment, so the fact that noticeable clinical improvement was observed as early as day 5 in these acutely ill patients is very important," said Miranda Chakos, M.D. Professor of Psychiatry, State University of New York at Downstate, Brooklyn, N.Y., and one of the investigators of the trial. "INVEGA is an important treatment option for patients diagnosed with schizophrenia. This trial showed beneficial effects of INVEGA in severely ill, hospitalized patients with an acute exacerbation of schizophrenia."

In the study, 399 patients with an acute exacerbation of symptoms of schizophrenia were randomized to receive INVEGA, SEROQUEL or placebo. These patients were either hospitalized or in need of hospitalization at the start of the trial and willing to remain hospitalized for a minimum of 10 days. The study involved two phases: a two-week monotherapy phase (primary endpoint) followed by a four-week additive therapy phase (secondary endpoint). During the four-week phase, patients could be prescribed additional psychotropic therapy as clinically indicated to manage psychiatric symptoms.

Recent trials in hospitalized patients have suggested the need for higher doses in the treatment of acute patients(2). This study examined the effects of recommended labeled doses while taking into account common clinical practice for this patient population. INVEGA was initiated at the recommended starting dose of 6mg/day (days one to three) increasing to 9 mg/day on day four. As these patients were acutely ill, there was an option to increase the dose to 12 mg/day on day eight. SEROQUEL was titrated to 600 mg/day by day five with an option to increase the dose to 800 mg/day on day eight. Because this study enrolled severely ill patients with recent onset of symptoms, patients were more likely to require doses near the upper end of the recommended ranges to control their symptoms. The average doses during the monotherapy phase were 10.4 mg/day for INVEGA and 690.9 mg/day for SEROQUEL.

The primary efficacy endpoint was total change in PANSS score from baseline to the end of the monotherapy phase (day 14). The average PANSS score at baseline was 102.8 (plus or minus 13.1) for the INVEGA group, 101.6 (plus or minus 13.5) for the SEROQUEL group, and 103.8 (plus or minus 15.7) for the placebo group. At the end of the monotherapy phase (day 14), the change in the total score from baseline was: -23.4 (1.8) for INVEGA, - 17.1(1.8) for SEROQUEL and -15.0 (2.2) for placebo, with INVEGA showing a significant reduction in symptoms over both SEROQUEL (p < less than > 0.001) and placebo (p < less than > 0.001).

In a separate analysis, INVEGA(TM) also produced a statistically significant improvement in the reduction in the individual symptom domains of the PANSS, which includes positive symptoms, negative symptoms, disorganized thoughts and uncontrolled hostility/excitement, than quetiapine (p < less than or equal to > 0.008) and placebo (p < less than or equal to > 0.003) at two weeks. In the additive therapy phase (days 15-42), 52.9 percent of patients taking INVEGA received optional additive therapy compared with 55.4 percent of patients taking SEROQUEL.

Discontinuation rates due to adverse events were: INVEGA (4%), SEROQUEL (10%) and placebo (6%). In the monotherapy phase, adverse events that occurred with an incidence of < greater than > 10 percent were headache (INVEGA 12%, SEROQUEL 8% and placebo 14%), somnolence (9%, 12%, 1%), tremor (14%, 5%, 8%), and insomnia (10%, 9%, 11%). In the additive therapy phase, adverse events that occurred with an incidence of < greater than > 10% were headache (INVEGA 14%, SEROQUEL 12% and placebo 16%), hypertonia (12%, 4%, 4%), sedation (4%, 11%, 4%), somnolence (11%, 15%, 3%), tremor (20%, 8%, 15%), dizziness (4%, 15%, 1%), schizophrenia (6%, 9%, 13%) and insomnia (12%, 10%, 15%).

During the study, 8 percent of the INVEGA patients reported a serious adverse event (SAE), compared to 4 percent of SEROQUEL patients and 3 percent of patients on placebo. The only SAE reported in more than two percent of patients was schizophrenia (INVEGA 4%, SEROQUEL 2%, and placebo 0%).

Ortho-McNeil Janssen Scientific Affairs, LLC and Johnson & Johnson Pharmaceutical Research & Development, LLC sponsored this clinical study. Additional details about the study are available upon request.

INVEGA, an atypical antipsychotic medication, was first approved in the U.S. in December 2006. 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.

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 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 as by disorganized thinking.

IMPORTANT SAFETY INFORMATION FOR INVEGA(TM)

INVEGA(TM) (paliperidone) Extended-Release Tablets is indicated for the acute and maintenance treatment of schizophrenia.

IMPORTANT SAFETY INFORMATION FOR INVEGA(TM)

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 healthcare 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 healthcare 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 healthcare 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 healthcare professional.

Inform your healthcare 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 healthcare 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.

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 www.janssen.com.

(a) Quetiapine, commercially available as SEROQUEL(R), was approved for the treatment of schizophrenia in 1997 and is one of the most prescribed atypical antipsychotic agents of the dibenzothiazepine class (all atypical prescriptions, total prescriptions Jan 05 - April 07; new prescriptions Sept 04 - April 07, IMS Health, National Prescription Audit).

(b) Positive and Negative Syndrome Scale for Schizophrenia (PANSS) is a standard rating scale used in trials to assess the severity of symptoms. The scale consists of 30 items, which are assessed from absent to extreme, and these are divided into both positive and negative symptoms.

References

(1) Canuso C, Dirks B, Carothers J et al., A comparative analysis of paliperidone ER and quetiapine in patients with a recent, acute exacerbation of schizophrenia, presented at the 20th Annual U.S. Psychiatric and Mental Health Congress in Orlando, Florida.

(2) Citrome L, Jaffe A, Levine J, et al., Dosing of quetiapine in schizophrenia: how clinical practice differs from registration studies. J. Clinical Psychiatry 2005 Dec; 66(12): 1512-1516

CONTACT: Media, Ambre Morley of Janssen, L.P., +1-908-507-0160,
amorley1@gpcus.jnj.com; Investors, Louise Mehrotra, +1-732-524-6491, Stan
Panasewicz, +1-732-524-2524, Lesley Fishman, +1-732-524-3922, all of
Johnson & Johnson

Web site: http://www.janssen.com/


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