Posted by JLM on December 12, 2003, at 3:30:33
In reply to Re: Cymbalta/Duloxetine timing, posted by pseudonym on July 21, 2003, at 13:44:22
> Manipulating SE and NE is such a broad and diverse area of research. Your dismissive statement of "just manipulating SE and NE" seems to conclude that any research into these two neurotransmitters is a failed avenue of research. Wrong.
>
> For one, duloxetine has much lower K(i) values, which indicates it prevents re-uptake much more potently than Effexor, in vivo. Furthermore, it takes a lot less of it to do so, as indicated by much lower ED-50 values. Finally, it prevents re-uptake of NE at much lower dosage levels than Effexor. The clincal trial data is also promising, but I'm not going to reiterate that here. My prediction: You're going to come back with a mea culpa in 6-9 months, and be happy to do so.
Here's my mea culpa my friend ;)"Lilly believed the original Prozac patent held in the United States until December 2003. But in the week ending August 12th, an appellate court ruled competitors could begin to produce generic versions of fluoxetine from February 2001. Lilly’s stock fell from a capitalization of $123 billion to $85 billion, making it vulnerable to takeover. Suddenly it had considerable incentive to settle all cases and to prepare to trash Prozac and the generic fluoxetines that would appear in 2001, making way for the new improved molecule they hoped to launch in 2003. Zettler and Vickery applied between them to depose Teicher, Beasley, and a series of Lilly lawyers, including Doug Norman, who had been present in Hawaii. Teicher, extraordinarily, would be deposed effectively as a Lilly scientist and Beasley was to be quizzed about the clinical trials program for the new compound, in particular about what steps were being taken to determine its suicide potential.
Then, in October 2000, Lilly shelved its development plans for R-fluoxetine (Zalutria). The investigation of the cardiac profile of dextra-fluoxetine suggested that the company might not get the new drug to market in time to forestall the competition.40 Sepracor’s stock plummeted by 25%.41 Lilly was left with only duloxetine, a 1980s serotonin and norepinephrine reuptake inhibitor, in its antidepressant pipeline.42
I had first been approached about participating in a clinical trial of duloxetine in the early 1990s, before the company shelved the compound, as far as I knew because of bladder side effects. US psychopharmacologists dutifully praised the development that duloxetine constituted. But, probably unbeknownst to many of these experts, duloxetine had since been developed as a bladder stabilizer in many countries. Rebranding it as an antidepressant would raise interesting questions about duloxetine, not only among bladder specialists who knew nothing about its history as an antidepressant but also in the general public as well, who might well be mystified as to how a drug could be marketed for one condition in one country and an entirely different condition in others."
So, we are getting a drug that was shelved in the early 90's as an AD, and then subsequently marketed in other countries as a bladder stabilizer? Wow, Eli Lilly I'm really impressed!
Since r-fluoxetine went south, they NEED something
to keep them in the AD market. So what do they do? Pull out a drug that they themselves shelved (could that perhaps be because their own investigators didn't even think too much of it), put a new spin on the data, and get it to market.And the story about Teicher is just plain fascinating but that's another thread.
poster:JLM
thread:208072
URL: http://www.dr-bob.org/babble/20031208/msgs/289020.html