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Published on 5/22/2006 in the Prospect News Biotech Daily.

Eli Lilly study suggests greater improvement for Symbyax compared to lamotrigine in bipolar depression

By Lisa Kerner

Erie, Pa., May 22 - Eli Lilly & Co. said long-term data from a head-to-head study comparing Symbyax (olanzapine and fluoxetine HCl capsules) to lamotrigine in the treatment of bipolar depression suggests that patients taking Symbyax experienced significant improvement in overall severity of illness and depressive and manic symptoms.

Efficacy was measured using three commonly used scales: the Clinical Global Impression Severity (CGI-S) (used as the primary outcome measure), Montgomery-Asberg Depression Rating Scale and Young-Mania Rating Scale, according to a company news release.

Symbyax is the first acute treatment approved by the Food and Drug Administration for the depressive phase of bipolar disorder.

In the multicenter, double-blind, parallel 25-week study, patients suffering from an acute episode of bipolar 1 depression were randomized to treatment with Symbyax (6/25, 6/50, 12/25 or 12/50 mg/day) or lamotrigine (200 mg/day).

Response was well maintained in both treatment groups, with no difference in the incidence of relapse, the company said.

Symbyax-treated patients experienced a greater incidence of weight gain, somnolence, increased appetite, dry mouth, sedation, tremor, lethargy, disturbance in attention and peripheral edema.

More patients treated with lamotrigine reported insomnia, irritability, and joint pain.

Lilly is a pharmaceutical products company based in Indianapolis.


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