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Yvette N Lamb, Gillian M Keating
A 3-monthly formulation of intramuscular paliperidone palmitate (3-monthly paliperidone palmitate) has recently been approved for the maintenance treatment of schizophrenia in adult patients in the EU (Trevicta(®)), following earlier approval in the USA (Invega Trinza(®)). This narrative review discusses the clinical use of 3-monthly paliperidone palmitate in the maintenance treatment of schizophrenia in adult patients and summarizes its pharmacological properties. The efficacy of the 3-monthly paliperidone palmitate formulation as a maintenance treatment for schizophrenia has been demonstrated in well designed, phase III trials...
October 3, 2016: Drugs
Noor Daghistani, Jose A Rey
Paliperidone palmitate three-month injection (Invega Trinza): the first four-times-a-year, long-acting injectable antipsychotic agent for schizophrenia.
April 2016: P & T: a Peer-reviewed Journal for Formulary Management
Celine M Laffont, Roberto Gomeni, Bo Zheng, Christian Heidbreder, Paul J Fudala, Azmi F Nasser
RBP-7000 is a long-acting formulation of risperidone designed for once-monthly subcutaneous injection for the treatment of schizophrenia. The objective was to estimate clinically effective doses of RBP-7000 based on model simulations and on the comparison with other long-acting injectable antipsychotics. A population pharmacokinetic model of RBP-7000 was developed in 90 clinically stable schizophrenic patients having received single/repeated doses of 60, 90, or 120 mg. Model simulations were conducted to compare active moiety plasma exposure after repeated RBP-7000 administrations to the published data of long-acting risperidone injection (Risperdal® Consta®) at 25 and 50 mg, and of paliperidone palmitate (Invega® Sustenna®) at 50 and 100 mg equivalent paliperidone...
January 2015: Journal of Clinical Pharmacology
Islam Rasem Younis, Thomas P Laughren, Yaning Wang, Mitchell Mathis, Jogarao V Gobburu
The Food and Drug Administration recently approved Invega for the treatment of schizophrenia in adolescents 12 to 17 years. If dosing recommendations for this population would have been based only on the results of the single efficacy trial included in this program, paliperidone dosing in adolescents might have been limited to 3 mg/d in adolescents less than 51 kg and to 6 mg/d in adolescents greater than or equal to 51 kg. This article provides an illustration of a more integrated approach to arrive at dosing recommendation that included practical considerations, modeling and simulation of data from the clinical trial, and the totality of evidence for both paliperidone and the parent drug, risperidone...
April 2013: Journal of Clinical Psychopharmacology
Shunji Nagata, Aya Jin-nai, Ken-ichi Hirai, Mikako Baba, Kousuke Higashi, Yusuke Tanaka
The dissolution profiles of paliperidone from INVEGA(®) 3-mg tablets, osmotic-controlled release tablets, were evaluated by using the reciprocating cylinder method (RC method). We used 4 different compositions of the dissolution fluids, by considering the environment of the tablet in the gastrointestinal tract. After a lag time of 2 to 4 h, paliperidone was approximately dissolved to 24 h by zero-order release. The dissolution characteristics of paliperidone were not affected by the kind of the test medium, pH, and surfactant...
2013: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
Pierre S Chue, Erin M MacKenzie, James A Chue, Glen B Baker
Paliperidone, or 9-hydroxyrisperidone (Invega(®), Janssen, Antwerp, Belgium) is the major active metabolite of the atypical antipsychotic risperidone (Risperdal(®), Janssen). It possesses a similar, though not identical, receptor pharmacology to the parent molecule. There are additional differences in terms of its predominant renal metabolism, lower protein binding and decreased inhibition of P-glycoprotein leading to decreased potential for drug-drug interactions. Paliperidone is approved as an extended release (ER) tablet based on an osmotic-controlled release oral Push-Pull™ delivery system (Oral Osmotic System, OROS(®), Alza Corporation) for the treatment of schizophrenia...
December 2012: Expert Review of Neurotherapeutics
Pierre Chue, James Chue
Risperidone long-acting injection (RLAI) was the first second-generation antipsychotic available as a long-acting injection. Paliperidone (9-hydroxyrisperidone) is the active metabolite of risperidone, introduced initially as an extended release oral (ORal Osmotic System, OROS®, Alza Corporation) formulation (Invega®, Janssen). Paliperidone long-acting injection (PLAI) has now been developed as a suspension of paliperidone palmitate nanocrystals in an aqueous formulation (Invega Sustenna®, Xeplion®), administered monthly by intramuscular injection (deltoid or gluteal)...
December 2012: Expert Review of Neurotherapeutics
Natalie J Carter
Extended-release intramuscular paliperidone palmitate (Xeplion®; Invega® Sustenna®) [henceforth referred to as intramuscular paliperidone palmitate] is a long-acting injectable (LAI) formulation of the well established atypical antipsychotic agent paliperidone (9-hydroxyrisperidone), which is the major active metabolite of risperidone. This article reviews, from an EU perspective, the therapeutic efficacy and tolerability of intramuscular paliperidone palmitate in the treatment of adults with schizophrenia, and the pharmacology of paliperidone that is relevant to the intramuscular formulation...
May 28, 2012: Drugs
Kenji Nagino, Tadaishi Koh, Yasushi Harada
No abstract text is available yet for this article.
June 2011: Nihon Yakurigaku Zasshi. Folia Pharmacologica Japonica
Lily P H Yang
Oral paliperidone extended or prolonged release (Invega®) is an atypical antipsychotic, and is the first agent approved for the treatment of schizoaffective disorder. Paliperidone (or 9-hydroxyrisperidone) is the major active metabolite of the well known atypical antipsychotic risperidone, and its mechanism of action is thought to be the antagonism of dopamine D(2) and serotonin 5-HT(2A) receptors. The clinical efficacy of paliperidone was demonstrated in two 6-week, randomized, double-blind, placebo-controlled, multicentre trials in patients with schizoaffective disorder...
June 1, 2011: CNS Drugs
Claudine M Chwieduk, Gillian M Keating
Paliperidone, the major active metabolite of the atypical antipsychotic risperidone, is available in an oral extended-release (ER) formulation (Invega(R)) and is indicated for the acute and maintenance treatment of schizophrenia in adults in the US and the EU. Once-daily paliperidone ER provides stable plasma drug concentrations over a 24-hour period and may be initiated at therapeutically effective dosages without the need for titration. Paliperidone ER 3-12 mg/day improved Positive and Negative Syndrome Scale (PANSS) total scores (primary endpoint) from baseline to study end to a significantly greater extent than placebo in 6-week, double-blind trials in patients with acute symptoms of schizophrenia...
July 9, 2010: Drugs
Philip G Janicak, Elizabeth A Winans
Paliperidone extended-release tablet (paliperidone ER; INVEGA()) is an oral antipsychotic for the treatment of schizophrenia. The recommended dose range is 3-12 mg per day. Paliperidone ER utilizes the OROS((R)) delivery system, which allows for once-daily dosing. Its pharmacokinetic profile results in a more stable serum concentration. Paliperidone is 9-hydroxyrisperidone, the chief active metabolite of risperidone. It undergoes limited hepatic metabolism, thereby minimizing the risks of hepatic drug-drug and drug-disease interactions...
December 2007: Neuropsychiatric Disease and Treatment
Nicola Gervasoni, Christian Bryois, Rémy Barbe, Gilles Bertschy
In 2008 there is no major breakthrough in the field of psychopharmacology. Paliperidone, (Invega), or 9-hydroxyrisperidone, the main hydroxylated metabolite of risperidone, is now available in Switzerland. It has the same pharmacodynamic profile and a different pharmacokinetic profile, linked to an extended release preparation. Bupropion, an antidepressant with noradrenergic and dopaminergic activity, is now accepted on the Swiss market for the treatment of depression under the name of Wellbutrin. Until now, its indication was limited to tobacco withdrawal (under the name of Zyban)...
January 14, 2009: Revue Médicale Suisse
Jill A Fowler, Tawny L Bettinger, Tami R Argo
BACKGROUND: Paliperidone, which is available in extended-release (ER) tablets, was approved by the US Food and Drug Administration in 2007 for the acute and maintenance treatment of schizophrenia. It is the seventh second-generation antipsychotic (SGA) to be introduced to the US market. Paliperidone is the major active metabolite of risperidone, an established anti-psychotic agent. OBJECTIVE: This article reviews the available literature on the pharmacodynamics, pharmacokinetics, clinical efficacy, and tolerability of paliperidone...
February 2008: Clinical Therapeutics
Stephen R Marder, Michelle Kramer, Lisa Ford, Els Eerdekens, Pilar Lim, Mariëlle Eerdekens, Adam Lowy
BACKGROUND: Paliperidone extended-release tablet (paliperidone ER; Invega, Janssen L.P., Titusville, New Jersey) is an oral psychotropic for schizophrenia treatment. METHODS: Efficacy and safety of once-daily paliperidone ER (6 and 12 mg) were assessed versus placebo in 444 patients with acute schizophrenia in a 6-week, multicenter, double-blind, randomized, parallel-group study. An olanzapine (10 mg) treatment arm was included to confirm trial validity. RESULTS: Both doses of paliperidone ER demonstrated significant improvement in Positive and Negative Syndrome Scale (PANSS) total score (p < or = ...
December 15, 2007: Biological Psychiatry
(no author information available yet)
No abstract text is available yet for this article.
March 12, 2007: Medical Letter on Drugs and Therapeutics
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