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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 9 of 9. This is the beginning of the thread.
Posted by jrbecker on June 25, 2004, at 15:49:50
this doesn't mean that it won't be approved before then, but it does possibly hint at a longer delay to launch than originally expected. According to the Lilly camp, they are still projecting a summer release date.
http://www.biospace.com/news_story.cfm?StoryID=16595020&full=1Eli Lilly and Company (LLY) Action Date On Cymbalta Is Delayed
INDIANAPOLIS, June 24 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration has extended the action date for completion of its review of the investigational antidepressant Cymbalta(R) (duloxetine hydrochloride), Eli Lilly and Company 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.
About Lilly
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 http://www.lilly.com/ .
This press release contains forward-looking statements about the potential of Cymbalta for the treatment of major depressive disorder and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that the product will be approved in the timeline suggested or prove to be commercially successful. 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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGOPRN Photo Desk, photodesk@prnewswire.comEli Lilly and Company
CONTACT: David Shaffer of Eli Lilly and Company, +1-317-651-3710 voice,+1-877-656-9084 pager, djshaffer@lilly.comAP story:
http://www.forbes.com/technology/sciences/feeds/ap/2004/06/24/ap1432621.html
Posted by utopizen on June 25, 2004, at 21:12:13
In reply to Cymbalta action date delayed until late September, posted by jrbecker on June 25, 2004, at 15:49:50
In the mean time, people waiting for it will have to use Zyprexa and Prozac in separate pill form.
But if it helps, I suppose one could insert both into a muffin and eat the muffin, and then that would sort of be like taking Cymbalta, minus the cute color scheme that would have one color on half of it and another on the other side?
If anyone's got some sort of variation of psychosis or mania that makes them irrational or erratic about taking one pill but not the other, I suppose a compounding pharmacy would have to be used until the release. But I'm pretty sure there's no such variation like that.
Most docs probably won't prescribe it, because I read a doc who said it's silly and that he would refuse to prescribe it because he dismisses it as a marketing gimmick. The two drugs are already out. Oh, that and flexibility of either dose is likewise restricted.
Posted by gabbix2 on June 25, 2004, at 21:53:07
In reply to Re: Cymbalta action date delayed until late September, posted by utopizen on June 25, 2004, at 21:12:13
Zyprexa and Prozac in pill form is Symbyax
and I think it's already out. Cymbalta is Duloxetine.
Posted by hok on June 27, 2004, at 12:25:11
In reply to Re: Cymbalta action date delayed until late September » utopizen, posted by gabbix2 on June 25, 2004, at 21:53:07
Aarrgh!!! The FDA is trying our patience!
Posted by Cecilia on June 29, 2004, at 1:58:18
In reply to Re: Cymbalta action date delayed until late September, posted by hok on June 27, 2004, at 12:25:11
Anyone actually believe Cymbalta will ever be approved? Cecilia
Posted by SLS on June 29, 2004, at 12:14:16
In reply to Re: Cymbalta action date delayed until late September, posted by Cecilia on June 29, 2004, at 1:58:18
> Anyone actually believe Cymbalta will ever be approved? Cecilia
I think that it will probably be approved before the end of summer. I am under the impression that most of the hold up involves its indication for SUI (stress urinary incontinance). I'm not sure exactly what the issue is, though.
- Scott
Posted by Peter S. on July 2, 2004, at 21:47:55
In reply to Re: Cymbalta action date delayed until late September, posted by SLS on June 29, 2004, at 12:14:16
Good News! Bovine Cymbalta will be released- the cows should be here any day
Posted by theo on July 3, 2004, at 7:33:38
In reply to Bulletin: Cymbalta delayed till cows come home, posted by Peter S. on July 2, 2004, at 21:47:55
Where did you see "any day?" This is the most current info I've seen.
http://www.forbes.com/technology/sciences/feeds/ap/2004/06/24/ap1432621.html
Posted by Peter S. on July 3, 2004, at 21:22:33
In reply to Re: Bulletin: Cymbalta delayed till cows come home » Peter S., posted by theo on July 3, 2004, at 7:33:38
Sorry, that was my dry idea of a joke. The cows will be getting Cymbalta before we do. After all it has to come all the way from the Cymbaltic Sea near Eastern Prozacia, one of the lesser known former Soviet States.
> Where did you see "any day?" This is the most current info I've seen.
>
> http://www.forbes.com/technology/sciences/feeds/ap/2004/06/24/ap1432621.html
>
This is the end of the thread.
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