Role of extended release quetiapine in the management of bipolar disorders

Abstract

Atypical antipsychotics have become a widely utilized component of the bipolar disorder treatment armamentarium, with approximately 45% of bipolar patients prescribed atypicals. Over the last decade all atypical drugs except for clozapine have received a Food and Drug Administration (FDA) bipolar indication. In October 2008, the FDA approved quetiapine XR monotherapy for the treatment of acute depressive episodes of bipolar disorder and acute manic or mixed episodes in bipolar I disorder based on two placebo-control trials. Quetiapine was also approved as adjunct therapy with lithium and divalproex for the treatment of acute manic or mixed episodes as well as maintenance of bipolar I disorder. In contrast to immediate release quetiapine which may require a twice-daily regimen, the XR formulation is intended for once-daily administration. This drug profile of quetiapine XR will address chemistry, pharmacodynamics, pharmacokinetics, metabolism, safety and tolerability and clinical trials in bipolar disorder.

Quetiapine for bipolar depression

“…Indeed, although there are no comparative data on the efficacy and tolerability of the two formulations of quetiapine in patients with bipolar depression thus far, there is a consensus that they do not broadly differ from one another (Al Jurdi et al, 2010). Indeed, although there are no comparative data on the efficacy and tolerability of the two formulations of quetiapine in patients with bipolar depression thus far, there is a consensus that they do not broadly differ from one another (Al Jurdi et al, 2010).…”

“…Furthermore, the newer extended release (XR) formulation of quetiapine, intended to be administered as a once-daily dosing, has been recently approved for the treatment of BD as well (Velligan et al, 2009;Yatham et al, 2009). Overall, data from both preclinical and clinical studies converge on suggesting the potential usefulness of quetiapine for patients with BD experiencing a depressive episode, and an increasing number of reviews have recently supported this view (Bogart and Chavez, 2009;Al Jurdi et al, 2010;Cristancho and Thase, 2010;Zhornitsky et al, 2011). It is worth mentioning, however, that a systematic review of available evidence on the acute and long-term effects of quetiapine for bipolar depression that uses a meta-analytic procedure and provides information about the existence of possible moderators of outcome has been lacking so far.…”

Therapie der akuten Manie

“…Dabei hat sich in den Zulassungsstudien die Dosierung von 600 mg am Abend nicht als überlegen gegenüber 300 mg am Abend erwiesen. Somit liegt die Gesamtdosis für die retardierte Form unter der für das nicht retardierte Quetiapin empfohlenen Dosierung von 400 bis 800 mg/Tag (34,35). Die tägliche orale Einmalgabe der als Tablette vorliegenden Substanz erleichtert möglicherweise die Compliance, vor allem während der Rezidivprophylaxe unter ambulanten Bedingungen.…”

Development of a level A in vitro-in vivo correlation for extended release dosage forms of quetiapine fumarate

“…The most common side effects are somnolence, postural hypotension, dizziness and dry mouth [3,6]. An extended-release (XR) formulation of quetiapine has been approved in the treatment of bipolar disorder and is intended to be administered as a once-daily dosing, which improves patient acceptance or adherence [7,8]. Quetiapine XR is well absorbed after oral administration.…”