Clinical pharmacology of paliperidone palmitate a parenteral long- acting formulation for the treatment of schizophrenia

Reviews on Recent Clinical Trials

Volumn 7, Issue 1, 2012, Pages 2-9

  Gilday, Elizabeth ^a   Nasrallah, Henry A ^a  

^a UNIVERSITY OF CINCINNATI   (United States)

Author keywords

Atypical Antipsychotics; Long acting Injectable; Nonadherence; Paliperidone Palmitate; Schizophrenia

Indexed keywords

CARBAMAZEPINE; DOPAMINE 2 RECEPTOR; DOPAMINE RECEPTOR STIMULATING AGENT; GLUCOSE; INSULIN; LEVODOPA; LIPID; PALIPERIDONE; PROLACTIN; RISPERIDONE; SEROTONIN 2A RECEPTOR;

AGITATION; AKATHISIA; AMENORRHEA; AREA UNDER THE CURVE; ARTICLE; DEPRESSION; DIZZINESS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG FORMULATION; DRUG METABOLISM; DRUG RECEPTOR BINDING; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EXTRAPYRAMIDAL SYMPTOM; GLUCOSE BLOOD LEVEL; HEADACHE; HEART RATE; HUMAN; HYPERKINESIA; INJECTION SITE PAIN; INJECTION SITE REACTION; INSOMNIA; KIDNEY FUNCTION TEST; LIPID BLOOD LEVEL; LIVER FUNCTION TEST; MAINTENANCE THERAPY; MYALGIA; ORTHOSTATIC HYPOTENSION; PARKINSONISM; PATIENT COMPLIANCE; PRIORITY JOURNAL; PROLACTIN BLOOD LEVEL; PSYCHOSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; RHINOPHARYNGITIS; SCHIZOPHRENIA; SEDATION; SIDE EFFECT; SINGLE DRUG DOSE; SOMNOLENCE; TACHYCARDIA; WEIGHT CHANGE; WEIGHT GAIN;

ANTIPSYCHOTIC AGENTS; CLINICAL TRIALS AS TOPIC; HUMANS; ISOXAZOLES; PALMITATES; SCHIZOPHRENIA;

EID: 84857395702     PISSN: 15748871     EISSN: 18761038     Source Type: Journal    
DOI: 10.2174/157488712799363307     Document Type: Article

References (24)

1. Dixon L, Perkins D, Calmes C. American Psychiatric Association. Practice guideline for the treatment of patients with schizophrenia. American Psychiatric Association, September 2009.
2. Nasrallah HA. The case for long-acting antipsychotic agents in the post-CATIE era. Acta Psychiatr Scand 2007; 115: 260-7.
3. Lieberman JA, Stroup TS, McEvoy JP, et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 2005; 353: 1209-23.
4. Marcus SC, Olfson M. Outpatient antipsychotic treatment and inpatient costs of schizophrenia. Schizophr Bull 2008; 34(1): 173-180.
5. Pandina GJ, Lindenmayer J-P, Lull J, et al. A randomized, placebocontrolled study to assess the efficacy and safety of three doses of paliperidone palmitate in adults with an acute exacerbation of schizophrenia. Presented at International Congress on Schizophrenia Research. San Diego, CA, USA, 2009.
6. Kramer M, Litman R, Hough D, et al. Paliperidone palmitate, a potential long-acting treatment for patients with schizophrenia. Results of a randomized, double-blind, placebo-controlled efficacy and safety study. Int J Neuropsychopharmacol 2009; 1-13.
7. Fleischhacker WW, Gopal S, Samtani MN, et al. Optimization of the dosing strategy for the long-acting injectable antipsychotic paliperidone palmitate: Results of two randomized double-blind studies and population pharmacokinetic simulations. Presented at the American Psychiatric Association Annual Meeting. San Francisco, CA, USA, NRI027 2009.
8. Gopal S, Vijapurkar U, Lim P, et al. Long-term efficacy, safety and tolerability of paliperidone palmitate in patients with schizophrenia. Presented at the Annual Meeting of the College of Psychiatric and Neurologic Pharmacists. Jacksonville, FL, USA, 20 2009.
9. Samtani MN, Sliwa JK, Haskins JT, et al. Initiation dosing of deltoid intramuscular paliperidone palmitate in schizophrenia: pharmacokinetic rationale based on modeling and simulation. Presented at the Annual Meeting of the College of Psychiatric and Neurologic Pharmacists. Jacksonville, FL, USA, NRI046 2009.
10. Samtani MN, Haskins JT, Alphs L, et al. Maintenance dosing of once-monthly (4-weekly) paliperidone palmitate in schizophrenia: pharmacokinetic rationale based on population simulations. Presented at the Annual Meeting of the College of Psychiatric and Neurologic Pharmacists. Jacksonville, FL, USA, NRI036 2009.
11. Hoy SM, Scott LJ, Keating GM. Intramuscular Paliperidone Palmitate. CNS Drugs 2010; 24: 227-244.
12. Citrome L. Paliperidone palmitate: review of the efficacy, safety, and cost of a new second-generation depot antipsychotic medication. Int J Clin Pract 2010; 64: 216-239.
13. Cleton A, Rossenu S, Hough D, et al. Evaluation of the pharmacokinetic profile of deltoid versus gluteal intramuscular injections of paliperidone palmitate in patients with schizophrenia. Presented at ASCPT. Orlando, FL, USA, 2008.
14. Nasrallah HA, Gopal S, Gassmann-Mayer C, et al. A controlled, evidence based trail of paliperidone palmitate, a long-actining injectable antipsychotic, in schizophrenia. Nephropsychopharmacology 2010; 35: 2072-2082.
15. Hough D, Gopal S, Vijapurkar U, et al. Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. Schizophr Res 2010; 116: 107-17.
16. Alphs L, Bossie C, Kern Sliwa J, et al. Paliperidone palmitate: clinical response in subjects with schizophrenia with recent diagnosis vs. longer-time since diagnosis. Presented at the American Psychiatric Association Annual Meeting. San Francisco, CA, USA, NR6027, 2009.
17. Hough D, Lindenmayer JP, Gopal S, et al. Safety and tolerability of deltoid and gluteal injections of paliperidone palmitate in schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry 2009; 33: 1022-1031.
18. Samtani MN, Gopal S, Kern Sliwa J, et al. Switching to paliperidone palmitate from other antipsychotics: guidance based on pharmacokinetic modeling and simulation. Presented at the New Clinical Drug Evaluation Unit. Hollywood, FL, USA, I68: 2009.
19. Gregg C. Pregnancy, prolactin, and white matter regeneration. J Neurol Sci 2009; 285: 22-27.
20. Gregg C, Shikar V, Larsen P, et al. White matter plasticity and enhanced remyelination in the maternal CNS. J Neurosci 2007; 27: 1812-1823.
21. Andreasen NC, Napoulos P, Magnotta V, et al. Progressive brain change in schizophrenia: A prospective longitudinal study of firstepisode schizophrenia. Arch Gen Psychiatry 2011; 70: 672-679
22. Ellison-Wright I, Bullmore E. Meta-analysis of diffusion tensor imaging studies in schizophrenia. Schizophr Res 2009; 108: 3-10.
23. Nasrallah HA, Hopkins T, Pixley SK. Differential effects of antipsychotic and antidepressant drugs on neurogenic regions in rats. Brain Res 2010; 1354: 23-29.
24. Ortho-McNeil-Janssen Pharmaceuticals. Invega Sustenna (paliperidone palmitate) extended release injectable suspension: prescribing information. Available from URL: http://www.invegasustenna.com/invegasustenna/shared/pi/invegasu stenna.pdf