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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 14 of 14. This is the beginning of the thread.
Posted by jrbecker76 on October 31, 2007, at 12:47:41
how ironic...my old ad agency wins the account to market gepirone....
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ADWEEK
Hotlines: GSK Selects McCann Humancare For Anti-Depressant LaunchThu Oct 18, 7:07 PM ET
NEW YORK McCann Humancare here has landed creative duties on the launch of a new antidepressant from
GlaxoSmithKline known as Velexity, sources said.The IPG shop won the assignment after a review in which Havas' Euro RSCG, Omnicom's BBDO and WPP's Grey were the other finalists, said sources. Billings are estimated at more than $40 million. The winning agency, a GSK roster shop that also handles brands such as Avodart and Cervarix, declined to comment, and GSK in Research Triangle Park, N.C., did not return calls.
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Another positive sign is that GSK pharm sales have assigned regional sales reps to sell to area physicians. An FDA action date by Fri, Nov 2nd could possibly pave the way for launch within the next couple months.
Posted by Cecilia on October 31, 2007, at 21:44:58
In reply to Gepirone ER branded Velexity®, posted by jrbecker76 on October 31, 2007, at 12:47:41
They paid 40 million dollars to choose the name Velexity? Why didn't they just have a Psycho-babble poll; I'm sure someone here could have come up with a much better name for a mere million. Cecilia
Posted by linkadge on October 31, 2007, at 22:15:57
In reply to Re: Gepirone ER branded Velexity®, posted by Cecilia on October 31, 2007, at 21:44:58
So what does this mean for the approval of it?
Linkadge
Posted by Sigismund on November 1, 2007, at 16:35:56
In reply to Re: Gepirone ER branded Velexity®, posted by Cecilia on October 31, 2007, at 21:44:58
If the spent 40 million on the name, what will they spend on the trips, conferences, lunches and pens?
Posted by jrbecker76 on November 2, 2007, at 21:57:15
In reply to Re: Gepirone ER branded Velexity® » Cecilia, posted by Sigismund on November 1, 2007, at 16:35:56
http://money.cnn.com/news/newsfeeds/articles/prnewswire/NEF08802112007-1.htm
Fabre Kramer Pharmaceuticals Receives Decision From FDA on Gepirone ER for Major Depressive Disorder
November 02, 2007: 07:55 PM EST
HOUSTON, LONDON and RESEARCH TRIANGLE PARK, N.C., Nov. 2 /PRNewswire/ -- Fabre-Kramer Pharmaceuticals Inc. (FKP) and GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has issued a not approvable letter for the new drug application for gepirone extended- release (ER) tablets, submitted for the treatment of adults with major depressive disorder.The FDA had previously reviewed Phase I through III clinical data involving gepirone ER. In June 2004, the FDA requested an additional positive short-term trial in order to consider gepirone ER for approval as a new antidepressant treatment. Subsequently, FKP successfully conducted a trial in patients with major depressive disorder to respond to the FDA request for an additional positive pivotal study.
Those results were submitted to the FDA in May 2007. The not approvable letter issued today is based on the FDA review of those additional results along with other newly submitted and previously submitted data.
Fabre-Kramer and GlaxoSmithKline entered an agreement in February of this year for collaboration on the worldwide development and commercialization of gepirone extended-release tablets. Fabre-Kramer and GSK are evaluating the response from the FDA to determine appropriate next steps.
About Fabre-Kramer Pharmaceuticals
Fabre-Kramer Pharmaceuticals, headquartered in Houston, Texas, is engaged in acquiring, developing and commercializing psychotropic drugs that have significant market potential. In addition to gepirone ER, Fabre-Kramer has 10 other compounds in various stages of development for indications including depression, anxiety, schizophrenia, Parkinson's disease and insomnia. For more information, visit FKP's website at www.fabrekramer.com
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For more information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com.
Posted by Cecilia on November 3, 2007, at 6:22:56
In reply to Velexity® (Gepirone ER) NOT APPROVABLE, posted by jrbecker76 on November 2, 2007, at 21:57:15
WHY? This was my last hope. Nothing else that I know of is coming out any time soon. Cecilia
Posted by Maria3667 on November 3, 2007, at 8:36:50
In reply to Re: Velexity® (Gepirone ER) NOT APPROVABLE, posted by Cecilia on November 3, 2007, at 6:22:56
Sigh !!
I had high hopes for this one too. Really dissapointed.
Maria
Posted by jrbecker76 on November 3, 2007, at 12:05:23
In reply to Re: Velexity® (Gepirone ER) NOT APPROVABLE, posted by Cecilia on November 3, 2007, at 6:22:56
> WHY? This was my last hope. Nothing else that I know of is coming out any time soon. Cecilia
Demonstrating a strong efficacy in clinical trials with the 5-HT1a partial agonists have been a plaguing problem. Part of the issue might be the fact that this class of drugs might be more of a useful tool as an add-on rather than a stand-alone treatment in itself. Secondly, in particular with gepirone, it has been purported to be specifically efficacious in depressives with atypical features. It is doubtful that the gepirone clinical trials screened out non-atypical depressives in these trials.
Another 5-HT1a drug (vilazodone), however, is pre-screening subjects and only admitting those with a particular genotype match (this particular genotype is known to have heightened efficacy with vilazadone in earlier trials). A third 5-HT1a partial agonist is PRX-00023, which is among a newly-engineered class of 1a agonists that are distinct from the older arylpiperazine class of HT1a compounds (buspirone, gepirone, etc). Data yielded from these trials in the coming year or so will either redeem the HT1a partial agonist's place in the treatment arsenal or finally put to rest their contended benefits.
Posted by linkadge on November 3, 2007, at 16:59:13
In reply to Re: Velexity® (Gepirone ER) NOT APPROVABLE » Cecilia, posted by jrbecker76 on November 3, 2007, at 12:05:23
That really sucks. Drugs like gepirone would probably be really helpful for a number of conditions, even if onl as an add on.
I think that the FDA is giving new antidepressants a hard time on account of recent flack on possible suicide links to other AD's. I think that gepirone would be a lot less likely to induce treatment emergent suicidal ideation. 5-ht1a agonists have antiagressive effects, and probably do not activate the same gene profile as uptake inhibitors.
Gepirone probably has less punch to it than an SSRI, but I think it could really help certain patients achieve improvement over the long term.
The FDA is a bunch of loosers, with no eye for promising treatments.
Linkadge
Posted by iforgotmypassword on November 6, 2007, at 10:03:59
In reply to Re: Velexity® (Gepirone ER) NOT APPROVABLE, posted by linkadge on November 3, 2007, at 16:59:13
Posted by Cecilia on November 7, 2007, at 16:53:42
In reply to Re: Velexity® (Gepirone ER) NOT APPROVABLE » Cecilia, posted by jrbecker76 on November 3, 2007, at 12:05:23
> > WHY? This was my last hope. Nothing else that I know of is coming out any time soon. Cecilia
>
> Demonstrating a strong efficacy in clinical trials with the 5-HT1a partial agonists have been a plaguing problem. Part of the issue might be the fact that this class of drugs might be more of a useful tool as an add-on rather than a stand-alone treatment in itself. Secondly, in particular with gepirone, it has been purported to be specifically efficacious in depressives with atypical features. It is doubtful that the gepirone clinical trials screened out non-atypical depressives in these trials.
>
> Another 5-HT1a drug (vilazodone), however, is pre-screening subjects and only admitting those with a particular genotype match (this particular genotype is known to have heightened efficacy with vilazadone in earlier trials). A third 5-HT1a partial agonist is PRX-00023, which is among a newly-engineered class of 1a agonists that are distinct from the older arylpiperazine class of HT1a compounds (buspirone, gepirone, etc). Data yielded from these trials in the coming year or so will either redeem the HT1a partial agonist's place in the treatment arsenal or finally put to rest their contended benefits.
>
>
It'll be years if ever, before these come out. I looked up info for a clinical tral of vilazadone, but they were only taking people whose "current episode" of depression was less than 2 years. That makes no sense, atypical depression is chronic. Is there any country in which gepirone has been approved? Cecilia
Posted by Maria3667 on November 7, 2007, at 18:27:41
In reply to Re: Velexity® (Gepirone ER) NOT APPROVABLE » jrbecker76, posted by Cecilia on November 7, 2007, at 16:53:42
Cecilia,
Who knows:
"Fabre-Kramer and GSK are evaluating the response from the FDA to determine appropriate next steps"
according to their press release.
I sincerely hope Europe is still within their scope. Or designating it for another disorder than depression (like what happened to Strattera)...
> > > WHY? This was my last hope. Nothing else that I know of is coming out any time soon. Cecilia
> >
> > Demonstrating a strong efficacy in clinical trials with the 5-HT1a partial agonists have been a plaguing problem. Part of the issue might be the fact that this class of drugs might be more of a useful tool as an add-on rather than a stand-alone treatment in itself. Secondly, in particular with gepirone, it has been purported to be specifically efficacious in depressives with atypical features. It is doubtful that the gepirone clinical trials screened out non-atypical depressives in these trials.
> >
> > Another 5-HT1a drug (vilazodone), however, is pre-screening subjects and only admitting those with a particular genotype match (this particular genotype is known to have heightened efficacy with vilazadone in earlier trials). A third 5-HT1a partial agonist is PRX-00023, which is among a newly-engineered class of 1a agonists that are distinct from the older arylpiperazine class of HT1a compounds (buspirone, gepirone, etc). Data yielded from these trials in the coming year or so will either redeem the HT1a partial agonist's place in the treatment arsenal or finally put to rest their contended benefits.
> >
> >
> It'll be years if ever, before these come out. I looked up info for a clinical tral of vilazadone, but they were only taking people whose "current episode" of depression was less than 2 years. That makes no sense, atypical depression is chronic. Is there any country in which gepirone has been approved? Cecilia
>
Posted by LostBoyinNCBecksDark on November 8, 2007, at 22:12:29
In reply to Velexity® (Gepirone ER) NOT APPROVABLE, posted by jrbecker76 on November 2, 2007, at 21:57:15
I have been hearing about Gepirone for at least five years. It has already been denied by the FDA once before. Perhaps the FDA is just doing its job, which is to require drug companies to prove their fantastic antidepressant actually works!
Based upon the things Ive read about Gepirone for years, I dont think it sounds like it works well as an AD.
I welcome a new and improved FDA that is going back to the way things used to be before the AIDS activists lobbied for faster, less restrictive drug approvals. It is very important for a medication to be both safe...as well as to actually work.
Eric
Posted by kaleidoscope on November 11, 2007, at 13:08:39
In reply to Re: Velexity® (Gepirone ER) NOT APPROVABLE » jrbecker76, posted by Cecilia on November 7, 2007, at 16:53:42
Cecilia,
Have you ever been part of a clinical trial? Perhaps there are some trials for treatment-resistant depression that you could join.
This is the end of the thread.
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