Eli Lilly: Symbyax may improve symptoms of treatment-resistant depression

By Elaine Rigoli

Tampa, Fla., May 23 - Eli Lilly said the results of a pooled analysis of two new parallel, randomized, double-blind studies suggest that Symbyax (olanzapine and fluoxetine HCl capsules) improved symptoms of treatment-resistant depression (TRD) when compared to either drug alone during a two-month period, based on the Montgomery-Asberg Depression Rating Scale (MADRS).

"Treatment-resistant depression is one of the greatest clinical challenges that psychiatrists face today, which is compounded by the fact that there is no FDA-approved medication for this illness," said Michael E. Thase, a professor of psychiatry at the University of Pittsburgh Medical Center and the Western Psychiatric Institute and Clinic.

Key findings in study 1 found that:

• While all three treatment arms demonstrated improvements from baseline, this double-blind study showed no statistically significant differences in MADRS improvement among the three treatment arms (Symbyax:-10.8; Prozac: -9.4; Zyprexa: -10.1).

Key findings in study 2 found that:

• This parallel double-blind study showed that patients taking Symbyax had average scores of -14.6 on the MADRS compared to Prozac (-9.0, p <0.001) and Zyprexa (-7.7, p < 0.001) alone;

• 44% of the Symbyax patients responded to therapy, as opposed to 30% of Prozac patients and 17% of Zyprexa patients.

Finally, pooled analysis showed:

• Significantly greater MADRS improvement for Symbyax (-12.6) versus Prozac (-9.2, p < .001) and Zyprexa (-8.9, p < .001) alone;

• 40% of Symbyax patients responded to therapy, as opposed to 30% of Prozac patients and 26 percent of Zyprexa patients;

• Within three to four days, Symbyax patients began to show significantly greater symptom improvement when compared to Prozac patients. At seven days, Symbyax also showed significantly greater symptom improvement when compared to Zyprexa.

Based in Indianapolis, Eli Lilly is a global pharmaceutical company.

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