The US Food and Drug Administration (FDA) has approved a new indication for Symbyax (olanzapine and fluoxetine HCl capsules), Eli Lilly and Company announced. Symbyax is now the first drug approved by the FDA for the acute treatment of treatment-resistant depression (TRD).

"Living with major depressive disorder is difficult and distressing for anyone, but even more so for patients whose symptoms continue despite treatment," said Lilly Medical Director Dr. Sara Corya. "Until today, there has been no approved medication for treatment-resistant depression. Now, after two failed attempts with other antidepressants, doctors and patients have a new treatment option."

In other actions, the FDA approved two new combination indications for Zyprexa (olanzapine) and fluoxetine for the acute treatment of bipolar depression and TRD. Lilly originally, developed Prozac (fluoxetine HCl), the branded version of fluoxetine.

Additionally, the format of the product labels was updated according to the Physician's Labelling Rule (PLR), which many consider easier to understand. Additions were also made to the Medication Guides for Symbyax and Prozac, and a new Medication Guide was created for Zyprexa. Medication Guides include information for patients about potential risks associated with a particular product.

"Lilly maintains its commitment to patients by the continued research of Zyprexa, Symbyax, and Prozac," said Dr Cherri Miner, Lilly neuroscience senior medical director. "Today's new indications confirm that these medications are valuable tools for patients in the fight against severe and disabling mental illness, and expand treatment options for prescribers and patients."

With these FDA approvals, clinicians in the United States have the choice to use the single pill option (Symbyax), or the two drugs (Zyprexa and fluoxetine) together, allowing physicians to tailor treatment to each patient's needs. Neither Zyprexa nor fluoxetine are indicated as monotherapy for bipolar depression or TRD.

In addition to the new indications, Lilly has updated the Symbyax and Zyprexa labels to include additional information regarding weight gain, hyperglycemia, and hyperlipidemia following the FDA's review of clinical trial data that Lilly submitted to the FDA between August 2007 and July 2008. In the course of this review, Lilly provided data from several large databases, including analyses of placebo-controlled data, comparator-controlled data, long-term data and special populations, including antipsychotic-naive patients.