Citrome L. Olanzapine pamoate: a stick in time? A review of the efficacy and safety profile of a new depot formulation of a second-generation antipsychotic. Int J Clin Pract 63: 140-150

New York University School of Medicine, Department of Psychiatry, NY, USA.
International Journal of Clinical Practice (Impact Factor: 2.57). 11/2008; 63(1):140-50. DOI: 10.1111/j.1742-1241.2008.01900.x
Source: PubMed


Olanzapine pamoate, a long-acting depot preparation of olanzapine, is being evaluated by regulatory agencies for the treatment of schizophrenia. Clinical trial information was accessed by on-line query of, and, along with an examination of poster presentations at scientific meetings held in 2008.
Two double-blind randomised clinical trials of olanzapine pamoate were conducted and demonstrate efficacy for both the acute treatment of schizophrenia and for the maintenance of antipsychotic response. Long-term open-label studies provide additional information on safety. The overall tolerability profile for olanzapine pamoate is similar to that for the oral formulation; however, with the depot there is a risk of a postinjection delirium sedation syndrome which resembles an overdose of oral olanzapine and which occurs in 0.07% of injections, requiring patients to be observed for 3 h after injection. At present, there are no studies available that directly compare olanzapine pamoate with other antipsychotics other than oral olanzapine.

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    • "Therefore, therapy that increased adherence to medication was believed to be of vital importance in schizophrenic patients suggesting that administration of a long-acting dosage form could reduce the risk of nonadherence to daily oral therapy. Consequently, long-acting injection of Olanzapine (Olanzapine Pamoate for intramuscular administration, dose 10–20 mg) was developed [17] and was found to be bioequivalent to oral Olanzapine therapy [18]. Available as the poorly water-soluble pamoate salt of Olanzapine, prolonged release in vivo is achieved by the control of dissolution rate. "
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    ABSTRACT: Theaimof this study was to prepare injectable depot formulations ofOlanzapine using four poly(D,L-lactide-co-glycolide) (PLGA) polymers of varying molecular weight and copolymer composition, and evaluate in vivo performance in rats. In vivo release profiles from the formulations were governed chiefly by polymer molecular weight and to a lesser extent, copolymer composition. Formulations A and B, manufactured using low molecular weight PLGA and administered at 10mg/kg dose, released drug within 15 days. Formulation C, prepared from intermediate molecular weight PLGA and administered at 20mg/kg dose, released drug in 30 days, while Formulation D, manufactured using a high molecular weight polymer and administered at 20mg/kg dose, released drug in 45 days. A simulation of multiple dosing at 7- and 10-day intervals for Formulations A and B revealed that steady state was achieved within 7–21 days and 10–30 days, respectively. Similarly, simulations at 15-day intervals for Formulations C and D indicated that steady state levels were reached during days 15–45. Overall, steady state levels for 7-, 10-, or 15-day dosing ranged between 45 and 65 ng/mL for all the formulations, implying that Olanzapine PLGA microspheres can be tailored to treat patients with varying clinical needs.
    Full-text · Article · Aug 2013
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    • "Worsening metabolic parameters (BMI and random glucose) were seen in four patients. These findings are in keeping with what is known about the effects of both oral and depot olanzapine on metabolic parameters [Citrome, 2009]. It reiterates the importance of balancing risks with bene-fits when considering olanzapine and of metabolic monitoring. "
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    ABSTRACT: Background: Oral olanzapine is a well-established treatment for patients suffering from schizophrenia. Advantages of depot olanzapine may include improved compliance. However, it is expensive, causes metabolic side effects, and carries a risk of postinjection syndrome. Clinical trials have shown olanzapine pamoate to be effective, but further work is needed in this area. This study was a retrospective service evaluation, carried out in a high-security hospital, where the majority of patients have complex, treatment resistant schizophrenia spectrum disorder and a very high propensity for violence. Compliance is a significant problem, both in the high-security setting and on discharge. There has been no previous published work that the authors are aware of evaluating the effects of olanzapine pamoate in this subgroup of patients. Methods: The aim of the study was to evaluate the clinical efficacy of olanzapine pamoate, its effect on violence as well as its side effects, in a high-security setting for the first time. Anonymized patient records were used to identify the main outcome measure and clinical global improvement, and to ascertain secondary outcome measures which included seclusion hours, risk of violence and side effects. Metabolic parameters and number of incidents were also recorded. Eight patients were treated with olanzapine pamoate. Results: Six showed an improvement in symptoms, with an associated decrease in violence and number of incidents. Four showed an associated decrease in seclusion hours. Two showed an increase in body mass index and two showed an increase in glucose. Conclusions: The findings of this study are important in showing that all patients who responded to olanzapine pamoate also showed a decrease in violent behaviour. The potential anti-aggression effects of olanzapine pamoate may represent a very promising area for further work. A depot antipsychotic medication that reduces violence could have significant implications for management of high-security patients.
    Full-text · Article · Jul 2013 · Therapeutic Advances in Psychopharmacology
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    • "However, other symptoms of an olanzapine overdose, like hypotension or respiratory depression, have not been reported after injection of the olanzapine depot (Detke et al. 2010). It should be noted that the PDSS can occur after any injection regardless how many prior uneventful injections the patient may have had (Citrome 2009). The risk for PDSS is greatest within the fi rst hour after injection ( Ͻ 1 in 1000 injections), Another 13-week study with a comparable design (25, 100, 150 mg paliperidone palmitate vs. placebo ) showed a superiority for reducing PANSS score in all treatment groups compared to placebo in a sample of acutely exacerbated schizophrenia patients (Pandina et al. 2010). "
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    ABSTRACT: These updated guidelines are based on a first edition of the World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for biological treatment of schizophrenia published in 2006. For this 2012 revision, all available publications pertaining to the biological treatment of schizophrenia were reviewed systematically to allow for an evidence-based update. These guidelines provide evidence-based practice recommendations that are clinically and scientifically meaningful. They are intended to be used by all physicians diagnosing and treating people suffering from schizophrenia. Based on the first version of these guidelines, a systematic review of the MEDLINE/PUBMED database and the Cochrane Library, in addition to data extraction from national treatment guidelines, has been performed for this update. The identified literature was evaluated with respect to the strength of evidence for its efficacy and then categorised into six levels of evidence (A-F) and five levels of recommendation (1-5) ( Bandelow et al. 2008a ,b, World J Biol Psychiatry 9:242, see Table 1 ). This second part of the updated guidelines covers long-term treatment as well as the management of relevant side effects. These guidelines are primarily concerned with the biological treatment (including antipsychotic medication and other pharmacological treatment options) of adults suffering from schizophrenia.
    Full-text · Article · Dec 2012 · The World Journal of Biological Psychiatry
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