Thursday, October 23, 2008

FDA Approvals: Seroquel XR, Risperdal Consta, Cinryze

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The US Food and Drug Administration (FDA) has approved quetiapine fumarate extended-release tablets for the treatment of manic and depressive episodes associated with bipolar disorder, a deltoid site of administration for risperidone long-acting injection, and a C1-esterase product for the prevention of hereditary angioedema attacks.

Once-Daily Quetiapine Fumarate (Seroquel XR) Approved for Bipolar Disorder

On October 8, the FDA approved new indications for quetiapine fumarate extended-release tablets (Seroquel XR; AstraZeneca), allowing its use for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex.

The approval for bipolar depression was supported by data from a placebo-controlled study of 280 acutely depressed adults with bipolar I or II disorder, showing that once-daily quetiapine therapy yielded significant improvements from baseline in the Montgomery Asberg Depression Rating Scale total score after 8 weeks of treatment (–17.4 vs –11.9; P < .001), with significant decreases in total score at week 1.

Approval of the bipolar mania indication was based on data from a randomized, placebo-controlled study (n = 316), showing that once-daily quetiapine was significantly more effective for achieving symptom improvement, as assessed by mean change in the Young Mania Rating Scale (YMRS) total score at week 3 (–14.3 vs –10.5; P < .001). According to a company news release, the reduction in YMRS was significant vs placebo at day 4.

In these studies, doses of extended-release quetiapine administered for bipolar mania (400 - 800 mg/day) and depression (300 mg/day) yielded comparable results to the FDA-approved recommended doses for immediate-release quetiapine for those indications.

"In these two studies quetiapine XR provided a reduction in symptoms for patients with bipolar disorder across mixed, manic and depressive episodes," said professor Patricia Suppes, from Southwestern Medical School in Houston, Texas. "That is encouraging for patients and physicians alike as a single medication that if approved can address the spectrum of mood episodes in bipolar disorder as a once-daily monotherapy is an attractive idea."

The approvals also provide for the use of the previously approved (but not marketed) 50-mg tablet for initiation of dose titration at a lower starting dose.

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