TITUSVILLE, N.J., Dec. 10 /PRNewswire/ -- Treatment with once-monthly INVEGA(R) SUSTENNA(TM) is not inferior to treatment with bi-weekly RISPERDAL(R) CONSTA(R), according to new data from a comparative study of both treatments in patients with schizophrenia. Results of the 13-week clinical trial were released this week.
The objective of this study was to show that INVEGA SUSTENNA was statistically similar (non-inferior) to RISPERDAL CONSTA, as measured by the Positive and Negative Syndrome Scale (PANSS). INVEGA SUSTENNA, a once-monthly injectable atypical antipsychotic, was recently approved in the U.S. for the acute and maintenance treatment of schizophrenia in adults. RISPERDAL CONSTA, the first long-acting injectable atypical antipsychotic, was approved for the treatment of schizophrenia in adults in the U.S. in 2003, and recently was approved for use as maintenance therapy in the treatment of Bipolar I Disorder.
About the Study
The 13-week, randomized, double-blind, double-dummy trial included 1220 adults with a diagnosis of schizophrenia and a PANSS total score of 60 to 120. Participants were randomly assigned to receive INVEGA SUSTENNA (IS) plus oral placebo or RISPERDAL CONSTA (RC) plus oral risperidone for the first three weeks.
The primary endpoint of the trial was the change in the PANSS total score versus baseline. Non-inferiority would be concluded by calculation using a 95% confidence interval (CI) based on a pre-specified change in total PANSS score. Secondary efficacy measures included change from baseline for Clinical Global Impression-Severity (CGI-S) and Personal and Social Performance (PSP) Scale.
The overall incidence of treatment-emergent adverse events (TEAEs) were comparable in the IS group (57.9%) and in the RC group (52.8%). TEAEs that occurred in more than 5% in both treatment groups were: insomnia, headache, somnolence, and injection-site pain. The incidence of extrapyramidal symptom-related TEAEs was similar for both treatment groups. The mean increases in body weight at endpoint also were similar between treatment groups (IS: 1.1 [3.36] kg; RC: 1.0 [3.14] kg).
INVEGA SUSTENNA was approved in July 2009 in the U.S. for the acute and maintenance treatment of schizophrenia in adults and utilizes the NanoCrystal(R) Technology, which is a proprietary technology developed by Elan Drug Technologies through Elan Pharma International Limited and other Elan affiliates.
IMPORTANT SAFETY INFORMATION FOR INVEGA(R) SUSTENNA(TM)
Neuroleptic Malignant Syndrome (NMS) is a rare, but serious side effect that could be fatal and has been reported with INVEGA(R) SUSTENNA(TM) and similar medicines. Call the doctor right away if you develop symptoms such as a high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness. Treatment should be stopped if you are being treated for NMS.
One risk of INVEGA(R) SUSTENNA(TM) is that it may change your heart rhythm. This effect is potentially serious. You should talk to your doctor about any current or past heart problems. Because these problems could mean you're having a heart rhythm abnormality, contact your doctor IMMEDIATELY if you feel faint or feel a change in the way that your heart beats (palpitations).
Weight gain has been observed with INVEGA(R) SUSTENNA(TM) and other atypical antipsychotic medications. If you notice that you are gaining weight, please notify your doctor.
INVEGA(R) SUSTENNA(TM) and similar medicines have been associated with decreases in the counts of white cells in circulating blood. If you have a history of low white blood cell counts or have unexplained fever or infection, then please contact your doctor right away.
INVEGA(R) SUSTENNA(TM) can make some people feel dizzy, sleepy, or less alert. Until you know how you are going to respond to INVEGA(R) SUSTENNA(TM), be careful driving a car, operating machines, or doing things that require you to be alert.
Some medications interact with INVEGA(R) SUSTENNA(TM). Please inform your healthcare professional of any medications or supplements that you are taking. INVEGA(R) SUSTENNA(TM) 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.
Do not drink alcohol while you are taking INVEGA(R) SUSTENNA(TM).
This is not a complete list of all possible side effects. Ask your doctor or treatment team if you have any questions or want more information.
IMPORTANT SAFETY INFORMATION FOR RISPERDAL(R) CONSTA(R)
Cerebrovascular Adverse Events (CAEs): CAEs, including fatalities, have been reported in elderly patients with dementia-related psychosis taking oral risperidone in clinical trials. The incidence of CAEs with risperidone was significantly higher than with placebo. RISPERDAL(R) CONSTA(R) is not approved for the treatment of patients with dementia-related psychosis.
Tardive Dyskinesia (TD): TD is a syndrome of potentially irreversible, involuntary, dyskinetic movements that may develop in patients treated with antipsychotic medications. The risk of developing TD and the likelihood that dyskinetic movements will become irreversible are believed to increase with duration of treatment and total cumulative dose. Elderly patients appeared to be at increased risk for TD. Prescribing should be consistent with the need to minimize the risk of TD. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.
Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors,
RISPERDAL(R) CONSTA(R) elevates prolactin levels and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents.
Leukopenia, Neutropenia and Agranulocytosis have been reported with antipsychotics, including risperidone. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have frequent complete blood cell counts during the first few months of therapy. At the first sign of a decline in WBC and in the absence of other causative factors, discontinuation of RISPERDAL(R) CONSTA(R) should be considered.
Seizures: RISPERDAL(R) CONSTA(R) should be used cautiously in patients with a history of seizures or with conditions that potentially lower seizure threshold.
Priapism has been reported. Severe priapism may require surgical intervention.
Administration: RISPERDAL(R) CONSTA(R) should be injected into the deltoid or gluteal muscle, and care must be taken to avoid inadvertent injection into a blood vessel.
Increased sensitivity in patients with Parkinson's disease or those with dementia with Lewy bodies has been reported. Manifestations and features are consistent with NMS.
Maintenance Treatment: Patients should be periodically reassessed to determine the need for continued treatment.
The most common adverse reactions in clinical trials in patients with bipolar disorder were weight increased (5% in monotherapy trial) and tremor and Parkinsonism (> 10% in adjunctive therapy trial).
About Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is headquartered in Raritan, New Jersey (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.
*Because doses of paliperidone palmitate can be expressed both in terms of milligram equivalents (mg eq.) of the pharmacologically active fraction of paliperidone and in milligrams of paliperidone palmitate, the doses expressed as 50, 100 and 150 mg eq. equate to 78, 156 and 234 mg respectively, of paliperidone palmitate.
(2)Sun SX, Liu GG, Christensen DB, Fu AZ. Review and analysis of hospitalization costs associated with antipsychotic nonadherence in the treatment of schizophrenia in the United States. Curr Med Res Opin. Oct. 2007; 23 (10): 2305-12.
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