The FDA has approved the injectable maintenance drug paliperidone palmitate (Invega Sustenna), making it the first once-monthly, atypical antipsychotic for schizophrenia.
The long-acting drug is approved for both acute and maintenance treatment.
The parent drug -- paliperidone in a once-daily tablet -- is an active metabolite of an old pharmaceutical, the atypical antipsychotic risperidone (Risperdal). (See Invega (paliperidone), Son of Risperdal (risperidone), Wins FDA Okay for Schizophrenia)
Researchers see once-monthly dosing as a potential solution for the medication adherence problems common in schizophrenia, noted Henry A. Nasrallah, MD, of the University of Cincinnati, an investigator in the paliperidone palmitate clinical trials.
"Inconsistent compliance with medications is arguably one of the single greatest impediments to managing the symptoms of schizophrenia and delaying the time to relapse," he said in a prepared statement.
READ MORE @ MEDPAGE TODAY
Showing posts with label risperidone. Show all posts
Showing posts with label risperidone. Show all posts
Thursday, August 6, 2009
Monday, May 4, 2009
AAN: Atypical Antipsychotic Reduces Autism Irritability
Aripiprazole (Abilify) may be effective off-label for treating the irritability associated with autism, researchers here said.
The atypical antipsychotic fared significantly better than placebo on a parent-rated scale of irritability (P<0.05), Donald Lewis, M.D., of Sentara Norfolk General Hospital in Virginia, and colleagues reported at the American Academy of Neurology meeting.
It also had significant advantages over placebo with regard to clinician assessments of Aripiprazole and hyperactivity.
Only one atypical antipsychotic -- risperidone (Risperdal) -- is currently FDA approved for irritability associated with autism. However, treatment guidelines recommended that other atypical antipsychotics be considered for behavioral problems in autism.
Researchers involved in the current study could not comment on whether aripiprazole was in the process of FDA approval for this indication.
But Benjamin L. Handen, Ph.D., of the University of Pittsburgh, who was not involved in this study but is involved in similar trials, said FDA approval for the indication would give doctors an alternative for children who respond poorly to risperidone.
READ MORE @ MEDPAGE TODAY
The atypical antipsychotic fared significantly better than placebo on a parent-rated scale of irritability (P<0.05), Donald Lewis, M.D., of Sentara Norfolk General Hospital in Virginia, and colleagues reported at the American Academy of Neurology meeting.
It also had significant advantages over placebo with regard to clinician assessments of Aripiprazole and hyperactivity.
Only one atypical antipsychotic -- risperidone (Risperdal) -- is currently FDA approved for irritability associated with autism. However, treatment guidelines recommended that other atypical antipsychotics be considered for behavioral problems in autism.
Researchers involved in the current study could not comment on whether aripiprazole was in the process of FDA approval for this indication.
But Benjamin L. Handen, Ph.D., of the University of Pittsburgh, who was not involved in this study but is involved in similar trials, said FDA approval for the indication would give doctors an alternative for children who respond poorly to risperidone.
READ MORE @ MEDPAGE TODAY
Tuesday, April 28, 2009
No Data Supporting Antipsychotic Drug for Low-IQ Kids With ADHD
A new Cochrane review finds no evidence to support the use of risperidone to treat attention- deficit/hyperactivity disorder (ADHD) in people with intellectual disabilities, even though the review authors say this is a common prescribing pattern.
Risperidone, or Risperdal, is a second-generation antipsychotic drug. Long-term use of these drugs is associated with serious side effects, including weight gain and increased risk for type 2 diabetes.
“People who have intellectual disability are more likely to receive treatment with second- generation antipsychotics for ADHD,” said lead review author Dr. Alex Thomson. “Doctors should be aware that there is no research to demonstrate the effectiveness of risperidone for ADHD in people with intellectual disability, and should carefully monitor each case and consider alternative treatments before trying risperidone.”
Laurel Leslie, M.D., an associate professor at Tufts University School of Medicine whose research centers on pediatric mental health, concurred: “This study demonstrates that we have a gap between what we’re doing clinically and what we have any research evidence for. It’s an important study, as it highlights the need for careful consideration of how we treat children’s mental health issues.” Leslie has no affiliation with the Cochrane review.
Thomson’s research group did not find one study that met their criteria for inclusion among more than 2,000 studies that they initially identified. The group analyzed 15 studies in depth, but ultimately rejected them all.
READ MORE @ NEWSWISE
Risperidone, or Risperdal, is a second-generation antipsychotic drug. Long-term use of these drugs is associated with serious side effects, including weight gain and increased risk for type 2 diabetes.
“People who have intellectual disability are more likely to receive treatment with second- generation antipsychotics for ADHD,” said lead review author Dr. Alex Thomson. “Doctors should be aware that there is no research to demonstrate the effectiveness of risperidone for ADHD in people with intellectual disability, and should carefully monitor each case and consider alternative treatments before trying risperidone.”
Laurel Leslie, M.D., an associate professor at Tufts University School of Medicine whose research centers on pediatric mental health, concurred: “This study demonstrates that we have a gap between what we’re doing clinically and what we have any research evidence for. It’s an important study, as it highlights the need for careful consideration of how we treat children’s mental health issues.” Leslie has no affiliation with the Cochrane review.
Thomson’s research group did not find one study that met their criteria for inclusion among more than 2,000 studies that they initially identified. The group analyzed 15 studies in depth, but ultimately rejected them all.
READ MORE @ NEWSWISE
Thursday, July 3, 2008
FDA Approves First Generic Risperidone to Treat Psychiatric Conditions
The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions.
"This generic drug approval is another example of the FDA's efforts to increase access to safe and effective generic drugs as soon as the law permits," said Gary Buehler, director of the FDA's Office of Generic Drugs in the Center for Drug Evaluation and Research.
Varying strengths of risperidone tablets, manufactured by TEVA Pharmaceuticals USA, have been approved. Specific information about the strengths approved can be found at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
The labeling of the generic risperidone may differ from that of Risperdal because some uses of the drug are protected by patents and exclusivity.
The generic risperidone products will have the same safety warnings as Risperdal, including a Boxed Warning that cautions that older patients with dementia-related psychosis treated with atypical anti-psychotic drugs are at increased risk of death compared with those taking placebo. Risperdal, and other antipsychotic medications, are not FDA-approved to treat dementia-related psychosis. The decision to use antipsychotic medications in the treatment of patients with symptoms of dementia is left to the discretion of the physician. Such use is often called "off-label" use and falls within the practice of medicine.
from FDA NEWS
"This generic drug approval is another example of the FDA's efforts to increase access to safe and effective generic drugs as soon as the law permits," said Gary Buehler, director of the FDA's Office of Generic Drugs in the Center for Drug Evaluation and Research.
Varying strengths of risperidone tablets, manufactured by TEVA Pharmaceuticals USA, have been approved. Specific information about the strengths approved can be found at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
The labeling of the generic risperidone may differ from that of Risperdal because some uses of the drug are protected by patents and exclusivity.
The generic risperidone products will have the same safety warnings as Risperdal, including a Boxed Warning that cautions that older patients with dementia-related psychosis treated with atypical anti-psychotic drugs are at increased risk of death compared with those taking placebo. Risperdal, and other antipsychotic medications, are not FDA-approved to treat dementia-related psychosis. The decision to use antipsychotic medications in the treatment of patients with symptoms of dementia is left to the discretion of the physician. Such use is often called "off-label" use and falls within the practice of medicine.
from FDA NEWS
Friday, April 4, 2008
New Findings in Early-Onset Schizophrenia
The Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS) study, funded by the NIMH, was a multicenter, controlled treatment trial of children and adolescents.1 The aim of the TEOSS study was to compare the efficacy and safety of risperidone and olanzapine with that of a traditional antipsychotic agent—molindone.
In this double-blind, parallel-group study, patients were randomized to receive risperidone, olanzapine, or molindone for 8 weeks followed by a 44-week, double-blind maintenance phase for responders. A total of 119 children and adolescents were randomized in the study. The results of the study, which should be reported in the near future, will provide needed information about the safety and tolerability of antipsychotic medications in youths with schizophrenia spectrum disorders.
The clinical characteristics of this large sample were recently reported and provide important information about the demographics and severity of illness in children and adolescents with early-onset schizophrenia and schizoaffective disorder.2 The mean age of onset of illness was 11.1 years. At the time of enrollment, the mean age of the patients was 13.8 years. The sex distribution was 66% male and 34% female. The racial breakdown was 62% white, 31% African Amer-ican, 3.4% Asian, 2.5% mixed, and 0.8% Pacific Islander. The average IQ of the sample was 93. Most of the youths lived with their family, 4% were hospitalized, and 7% lived in a group home or residential facility.
READ MORE @ PSYCHIATRIC TIMES
In this double-blind, parallel-group study, patients were randomized to receive risperidone, olanzapine, or molindone for 8 weeks followed by a 44-week, double-blind maintenance phase for responders. A total of 119 children and adolescents were randomized in the study. The results of the study, which should be reported in the near future, will provide needed information about the safety and tolerability of antipsychotic medications in youths with schizophrenia spectrum disorders.
The clinical characteristics of this large sample were recently reported and provide important information about the demographics and severity of illness in children and adolescents with early-onset schizophrenia and schizoaffective disorder.2 The mean age of onset of illness was 11.1 years. At the time of enrollment, the mean age of the patients was 13.8 years. The sex distribution was 66% male and 34% female. The racial breakdown was 62% white, 31% African Amer-ican, 3.4% Asian, 2.5% mixed, and 0.8% Pacific Islander. The average IQ of the sample was 93. Most of the youths lived with their family, 4% were hospitalized, and 7% lived in a group home or residential facility.
READ MORE @ PSYCHIATRIC TIMES
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