Source: DGNews  |  Posted 2 years ago

NEW YORK -- November 20, 2009 -- The US Food and Drug Administration (FDA) has
approved ziprasidone HCI (Geodon) tablets for maintenance treatment of bipolar
I disorder as an adjunct to lithium or valproate in adults.

The efficacy and safety of ziprasidone HCI for the adjunctive maintenance
treatment of bipolar disorder were studied in a 6-month, double-blind,
randomised, placebo-controlled trial in adult patients with bipolar I disorder.

After an open-label stabilisation period of 10 to 16 weeks, 240 patients were
randomised to continue on ziprasidone HCI plus lithium or valproate, or to have
ziprasidone HCI replaced by placebo. The primary endpoint was time to
recurrence of a mood episode requiring intervention.

The data demonstrated that ziprasidone HCI plus lithium or valproate was
superior to placebo plus lithium or valproate in increasing the time to
recurrence of a mood episode. During 6 months of treatment, 19.7% of patients
in the ziprasidone HCI arm required intervention for a mood episode, compared
with 32.4% of patients in the placebo arm.

The adjunctive treatment regimen was generally well-tolerated. Discontinuation
due to adverse events occurred in 13% of patients in the placebo group,
compared with 9 % of those in the ziprasidone HCI group.

The safety and tolerability data from this study are consistent with
ziprasidone’s already well-established safety profile in adult patients.

SOURCE: Pfizer