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The U.S. Food and Drug Administration (FDA) has approved a new indication for Symbyax(R) (olanzapine and fluoxetine HCl capsules), Eli Lilly and Company (NYSE: LLY) 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(R) (olanzapine) and fluoxetine for the acute treatment of bipolar depression and TRD. Lilly originally developed Prozac(R) (fluoxetine HCl), the branded version of fluoxetine.
Additionally, the format of the product labels was updated according to the Physician’s Labeling 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."
1. The new Symbyax TRD indication is for acute treatment of adult patients with major depressive disorder who have not responded to two separate trials of different antidepressants of adequate dose and duration in their current episode.
2. Zyprexa, in combination with fluoxetine, is now approved for the acute treatment of TRD in adults.
3. Symbyax was the first drug approved by the FDA for acute treatment of bipolar depression in adults in 2003. Zyprexa, in combination with fluoxetine, is now approved for the same indication.
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.
Symbyax and Zyprexa in Combination with Fluoxetine Supportive Study Details for TRD
The data package submitted to the FDA supporting the approval of Symbyax for TRD as well as the approval of Zyprexa in combination with fluoxetine for TRD, included one pivotal trial and data from three supportive trials and one inconclusive trial. The TRD-related label language includes efficacy data from three of these clinical studies (n=579). Acute safety information was based on a total of 10 studies. Doses evaluated in these studies ranged from 6-18 mg for olanzapine and 25-50 mg for fluoxetine in fixed combination.
– An eight-week randomized, double-blind, controlled study was conducted to evaluate the efficacy of Symbyax in patients (n=300) who met the fourth edition of "Diagnostic and Statistical Manual of Mental Disorders" (DSM-IV) criteria for major depressive disorder (MDD) and did not respond to two antidepressants of adequate dose and duration in their current episode. Patients who were not responding to an antidepressant in their current episode entered an eight-week open-label fluoxetine lead-in, and then non-responders were randomized (1:1:1) to receive an eight-week trial of Symbyax, olanzapine, or fluoxetine. Symbyax was flexibly dosed between 6/50 mg, 12/50 mg, and 18/50 mg (olanzapine/fluoxetine dose). Results from this study yielded a greater statistically significant reduction in mean total Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline to endpoint for Symbyax versus fluoxetine and olanzapine alone.
– A second study of 28 patients who met the same criteria for TRD demonstrated statistically significant greater reductions in MADRS scores for Symbyax versus fluoxetine and olanzapine alone.
– A third study demonstrated statistically significant greater reductions in total MADRS scores for Symbyax versus fluoxetine or olanzapine alone, when analyzed in a subpopulation of depressed patients (n=251) who met the same criteria for treatment resistance.
– Although not cited in the approved label, two additional studies were included in the sNDA data package. One of the trials provided statistically significant supporting data for Symbyax in the acute treatment of TRD, while the other trial was inconclusive.
– An integrated analysis of all five studies provided to the FDA yielded a statistically significant greater reduction in mean total MADRS scores from baseline to endpoint in the defined population for patients treated with Symbyax (-12.2) vs. fluoxetine (-8.5, p=0.015) and olanzapine (-7.7, p=0.007) and greater statistically significant remission rates (p= or = 5% and at least twice that for placebo) treatment-emergent adverse event associated with Symbyax in placebo-controlled clinical trials were weight gain, increased appetite, dry mouth, somnolence, fatigue, peripheral edema, tremor, sedation, hypersonmia, disturbance in attention, and blurred vision.
Full prescribing information, including boxed warnings, is available at and
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers — through medicines and information — for some of the world’s most urgent medical needs. Additional information about Lilly is available at
This press release contains forward-looking statements about Zyprexa, Prozac, and Symbyax. These statements reflect management’s current beliefs; however, as with any pharmaceutical product there are risks and uncertainties in the process of research and development, regulatory review, and commercialization. In addition, there are no guarantees that the products will continue to be commercially successful or will be successful in these new indications. For further discussion of these and other risks and uncertainties, see Lilly’s filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
(1) Nemeroff, C. Prevalence and Management of Treatment-Resistant Depression. J. Clin Psychiatry 2007; 68 (suppl. 8): 17-25.
(2) National Institutes of Health. Medline Plus. Major Depression. Accessed February 24, 2009. Available at
(3) Bipolar Disorder. Published by National Institute of Mental Health. NIH Publication No. 02-3679; Printed 2001, Reprinted September 2002. [Online] 4 March 2009 date last accessed.
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