CymbaltaTreatment for Diabetic Nephropathy, Fibromyalgia, Neuropathic Pain, Depression, Generalized Anxiety Disorder, Osteoarthritis, Pain
FDA Extends Action Date for Cymbalta for Continued Analysis of Already-Submitted Data
Company Continues to Expect Approval and Launch of New Antidepressant This Summer
INDIANAPOLIS, June 24, 2004 -- The U.S. Food and Drug Administration has extended the action date for completion of its review of the investigational antidepressant Cymbalta (duloxetine hydrochloride), Eli Lilly and Company (NYSE:LLY) announced today.
The extension stems from Lilly's recent submission, at the FDA's request, of additional analyses of already-submitted data from the Cymbalta New Drug Application. FDA regulations mandate that the extension be three months long, putting the new action date in late September. Based on ongoing discussions with the FDA, however, Lilly believes the agency is likely to complete its final review before the new action date.
As a result, Lilly, in line with current guidance, continues to expect approval and launch of Cymbalta this summer.
"We are eager to bring Cymbalta to market because it has the potential to help millions of people with depression," said John Lechleiter, executive vice president of pharmaceutical products and corporate development at Lilly. "We remain confident about the data we have submitted and the safety and efficacy profile Cymbalta has demonstrated in extensive clinical trials for depression."
About depression and Cymbalta
Despite important advances in treatment, depression remains one of the most common and costly chronic illnesses. Nearly 19 million Americans suffer from depression each year, making it a leading cause of disability, according to the World Health Organization. Studies show only one in three sufferers will ever achieve complete resolution of their symptoms. Research suggests an imbalance of two neurotransmitters play a key role, not only in the emotional symptoms of depression, but also in the painful physical symptoms commonly associated with depression.
Cymbalta is believed to affect the levels of two key neurotransmitters involved in depression -- serotonin and norepinephrine -- both implicated in the complex spectrum of major depression symptoms. Prozac(R) and many other common antidepressants, in contrast, affect only serotonin.
So far, more than 6,000 patients have taken Cymbalta in clinical trials for Major Depressive Disorder. Data suggest Cymbalta 60 mg taken once daily relieves symptoms of depression, such as low mood, anxiety and physical symptoms like aches and pains, as measured by a commonly used depression rating scale, the Hamilton Depression Rating Scale.
In placebo-controlled clinical trials, the most commonly observed adverse events (>/= 5 percent and at least twice placebo) for Cymbalta vs. placebo (n = 1,139 vs. 777) were: nausea (20 percent vs. 7 percent), dry mouth (15 percent vs. 6 percent), constipation (11 percent vs. 4 percent), decreased appetite (8 percent vs. 2 percent), fatigue (8 percent vs. 4 percent), sleepiness (7 percent vs. 3 percent), and increased sweating (6 percent vs. 2 percent). The overall discontinuation rate due to adverse events for Cymbalta vs. placebo was 10 percent vs. 4 percent. Nausea was the only common adverse event reported as a reason for discontinuation and considered to be drug related (1.4 percent vs. 0.1 percent).
Duloxetine hydrochloride also is being studied by Lilly for the treatment of stress urinary incontinence and diabetic neuropathic pain. All three conditions are believed to be mediated by serotonin and norepinephrine.
Lilly signed a commercialization agreement for Cymbalta in the United States with Quintiles Transnational Corp. in July 2002.
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 www.lilly.com.
Posted: June 2004
- FDA Clears Cymbalta to Treat Chronic Musculoskeletal Pain - November 5, 2010
- FDA Approves Cymbalta for Maintenance Treatment of Generalized Anxiety Disorder - November 30, 2009
- FDA Approves Cymbalta for the Management of Fibromyalgia - June 16, 2008
- FDA Approves Cymbalta for Maintenance Treatment of Major Depressive Disorder - November 30, 2007
- FDA Approves Cymbalta for Treatment of Generalized Anxiety Disorder - February 26, 2007
- FDA Approves Cymbalta for Neuropathic Pain Associated With Diabetes - September 7, 2004
- FDA Approves Cymbalta for the Treatment of Depression - August 4, 2004