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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 16 of 16. This is the beginning of the thread.
Posted by jrbecker on February 10, 2007, at 18:10:56
http://www.pharmalive.com/news/index.cfm?articleid=413548&search=1
Glaxosmithkline and Fabre-Kramer Pharmaceuticals Enter Global Agreement for New Treatment of Major Depressive Disorder
LONDON, HOUSTON, 8th February 2007-GlaxoSmithKline (GSK) and Fabre-Kramer Pharmaceuticals, Inc. (FKP) today announced an exclusive worldwide agreement for gepirone ER, a 5HT1a agonist expected to be submitted in this quarter for Food and Drug Administration (FDA) review in the US for major depressive disorder (MDD). The agreement includes development and commercialisation of gepirone ER as well as development opportunities for follow-on products.
Subject to approval, gepirone ER will be the first-in-class 5HT1a agonist indicated for the treatment of MDD, an illness for which there is still a great unmet need despite the availability of treatment options. Gepirone ER affects brain serotonin by binding to serotonin 5HT1a receptors. Clinical study data suggest that gepirone ER treats depression with a low risk for sexual side effects that are known to occur with current therapies that work via serotonergic mechanisms. These side effects often lead patients to discontinue therapy. In clinical trials, dizziness/lightheadedness and nausea were the most frequently reported adverse events and occurred most often during early stages of treatment. Discontinuations due to these adverse events were less than 5%.
Under the terms of the agreement, which are confidential between the companies, FKP will receive an upfront cash payment followed by additional milestone payments based on NDA approval and launch of the product. In addition, FKP will be entitled to receive commercial milestone payments and double-digit royalty payments on global sales of gepirone ER. In return, GSK will be granted an exclusive, worldwide license to develop, manufacture and commercialise gepirone ER and follow-on products.
Moncef Slaoui, Chairman of R&D, GSK, commented, “This is another late-stage programme addition to GSK’s R&D pipeline. We are pleased to work with FKP toward bringing a new alternative anti-depressant therapy with a potentially improved tolerability profile for patients suffering from major depressive disorder.”
Stephen J. Kramer, M.D., CEO of FKP, commented, "We are excited about this alliance because we are confident that GSK, through its outstanding experience in the depression market will, once approved, successfully commercialise and further develop gepirone ER to help the many depressed patients for whom existing therapies are simply not satisfactory.”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.
About Fabre-Kramer Pharmaceuticals
Fabre-Kramer Pharmaceuticals, headquartered in Houston, Texasis 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
GlaxoSmithKline Forward-Looking Statements
Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's Annual Report on Form 20-F for 2005.
GlaxoSmithKline enquiries:
UK Media enquiries:
Philip Thomson
Alice Hunt
Gwenan White
(020) 8047 5502
(020) 8047 5502
(020) 8047 5502
US Media enquiries:
Nancy Pekarek
Mary Anne Rhyne
Patricia Seif
(215) 751 7709
(919) 483 2839
(215) 751 7709
European Analyst/Investor enquiries:
Anita Kidgell
David Mawdsley
Sally Ferguson
(020) 8047 5542
(020) 8047 5564
(020) 8047 5543
US Analyst/Investor enquiries:
Frank Murdolo
Tom Curry
(215) 751 7002
(215) 751 5419
Fabre-Kramer Pharmaceuticals, Inc. enquires: Enquiries:
Edward H Koehler, Jnr
(713) 975 6900
Posted by alienatari on February 10, 2007, at 19:25:19
In reply to GSK and Fabre-Kramer make agreement on Gepirone ER, posted by jrbecker on February 10, 2007, at 18:10:56
Interesting article. Thanks for posting it. I hope this drug makes its way out to here in Australia.
Posted by linkadge on February 10, 2007, at 20:17:04
In reply to Re: GSK and Fabre-Kramer make agreement on Gepirone ER, posted by alienatari on February 10, 2007, at 19:25:19
Yeah, I pray they are not toying with us again. This is a treatment option that we deparately need.
A cleaner, more slective buspar could offer many people with either an effective monotherapy for anxiety/depression or a useful adjunctive in depression, schizophrenia, and even parkionsons, or cognative disorders.
Linkadge
Posted by linkadge on February 10, 2007, at 20:18:23
In reply to Re: GSK and Fabre-Kramer make agreement on Gepirone ER, posted by alienatari on February 10, 2007, at 19:25:19
Theoretically, it should mix well with a number of other drugs, from antidepressants to antipsychotics or stimulants.
Linkadge
Posted by flmm on February 10, 2007, at 21:11:40
In reply to Re: GSK and Fabre-Kramer make agreement on Gepirone ER, posted by linkadge on February 10, 2007, at 20:18:23
Will it be usefull for panic? I do not believe buspar was.
Posted by Phillipa on February 10, 2007, at 21:42:52
In reply to Re: GSK and Fabre-Kramer make agreement on Gepirone ER, posted by flmm on February 10, 2007, at 21:11:40
How effective will it be for anxiety that leads to depression? Anyone know? Love Phillipa
Posted by Cecilia on February 11, 2007, at 2:02:34
In reply to GSK and Fabre-Kramer make agreement on Gepirone ER, posted by jrbecker on February 10, 2007, at 18:10:56
Didn't the FDA already turn down Gepiron once? Is there new evidence that they will approve it this time? Cecilia
Posted by psychobot5000 on February 11, 2007, at 13:11:52
In reply to Re: GSK and Fabre-Kramer make agreement on Gepirone ER, posted by linkadge on February 10, 2007, at 20:17:04
>
> A cleaner, more slective buspar could offer many people with either an effective monotherapy for anxiety/depression or a useful adjunctive in depression, schizophrenia, and even parkionsons, or cognative disorders.
-Is- gepirone more selective or cleaner? That would certainly be useful.
Posted by linkadge on February 11, 2007, at 14:30:52
In reply to Re: GSK and Fabre-Kramer make agreement on Gepiron, posted by psychobot5000 on February 11, 2007, at 13:11:52
I was under the impression that gepirone had a much less d2 blocade (if any) as compared to buspar. I think it was also more potent at 5-ht1a than buspar, as well as well alpha-2 activity.
Linkadge
Posted by psychobot5000 on February 11, 2007, at 17:36:12
In reply to Re: GSK and Fabre-Kramer make agreement on Gepiron, posted by linkadge on February 11, 2007, at 14:30:52
> I was under the impression that gepirone had a much less d2 blocade (if any) as compared to buspar. I think it was also more potent at 5-ht1a than buspar, as well as well alpha-2 activity.
>
>
> LinkadgeThanks for the info--it's very useful. I never liked the feel of Buspar, but didn't realize it had a D2 blockade. Now that I think of it, it did feel a bit like various antipsychotics and D2 affecting meds I've taken--never liked them. Hopefully gepirone will indeed feel cleaner.
Posted by jealibeanz on March 9, 2007, at 5:03:53
In reply to Re: GSK and Fabre-Kramer make agreement on Gepirone ER, posted by linkadge on February 10, 2007, at 20:17:04
> Yeah, I pray they are not toying with us again. This is a treatment option that we deparately need.
>
> A cleaner, more slective buspar could offer many people with either an effective monotherapy for anxiety/depression or a useful adjunctive in depression, schizophrenia, and even parkionsons, or cognative disorders.
>
> Linkadge
OK, finally someone who is acknowledging this is somewhat like Buspar! I thought so, but couldn't fully understand the mechanisms.Buspar does state that hits all sorts of receptors-- 5-HTP, dopamine, alpha, histamine. So this is the selective version.
Hmm... I don't know what to think about this.
I took Buspar very briefly, after taking Paxil, my first AD for about a month for anxiety. I quit Paxil because of major weight gain, so my doc switched me. The weight gain continued.
I don't remember feeling any therapeutic effects of either Paxil or Buspar, I think because I was not on them long enough and because I was a teen with a whole lot going on. The anxiety was gonna be there with or without meds, and it's clouded my memory and self-reflection of the time period.
I switched to Wellbutrin right after that. Again I don't remember therapeutic benefits. Actually I remember being pretty anxious and depressed, but afraid of stopping in case it was helping a little. I did quit after 4 months though, because I gained 20 lbs on Wellbutrin (who knows why... some say this does target serotonin receptors a little, possibly due to the other things that the reuptake inhibitors hit in the brain or the rest of the body), while working out twice a day, ha ya, go figure. I remember feeling like I was being lifted out of a fog (aka apathy).
My next agent was Klonopin and Adderall. I didn't take it longer than a few days... parental disapproval... I was then scripted it 2 years later. Klonopin made me feel drug. Adderall made me crash into a depression... enter: the Effexor experience...
Effexor made me feel really good for about a week. Then it made me so unemotional I had to remind myself to react appropriately to the outside world, otherwise I was content to stare at walls. That was the decided point of me quitting. I decided I would rather feel unhappy than feel nothing at all. Oh yeah, and it made me so nausous I couldn't eat, yet gained 20 lbs in the 7 weeks I was on it.
Haha... so, to make a long story short, I don't think I will enjoy anything that targets serotonin. My body seems to dislike it. My doctor and PA always seem a little surprised at my extreme reactions to these antidepressents and anti-anxiety meds.
I'm not the norm. Leaves me with little options for depression unless I want to try another and be fat and apathetic. For anxiety at least I can have Xanax.
Posted by Phillipa on March 9, 2007, at 18:27:04
In reply to Re: GSK and Fabre-Kramer make agreement on Gepirone ER, posted by jealibeanz on March 9, 2007, at 5:03:53
Jelly well I may be older but my body is wierd too. And xanax always worked for me very well as monotherapy. Buspar I took when first out . I think the dose was like 5-l0mg my GP gave it to me and I showed it to my pdoc at the time he took it away didn't want me on it and said to stay on xanax. No weight gain with benzos either. Love Phillipa
Posted by jealibeanz on March 10, 2007, at 5:52:09
In reply to Re: GSK and Fabre-Kramer make agreement on Gepirone ER » jealibeanz, posted by Phillipa on March 9, 2007, at 18:27:04
> Jelly well I may be older but my body is wierd too. And xanax always worked for me very well as monotherapy. Buspar I took when first out . I think the dose was like 5-l0mg my GP gave it to me and I showed it to my pdoc at the time he took it away didn't want me on it and said to stay on xanax. No weight gain with benzos either. Love Phillipa
Oh but you're lucky. You can take AD's without weight gain! I can't.
I'm trying to be positive and use my youth to an advantage. Hopefully I will have the luxury of finding a yet-to-be-released medication that helps me. I'm too young to have dealt with this already for almost 10 years, let alone setence myself to a hopeless life.
Gotta have a little hope and faith... And a good caring doc! :)
Posted by River1924 on March 10, 2007, at 18:01:37
In reply to Re: GSK and Fabre-Kramer make agreement on Gepirone ER, posted by Cecilia on February 11, 2007, at 2:02:34
It was refused once. Besides newer clinical trials (I believe it was being tested as a treatment for atypical depression at one point), it will have a much better chance of passing the fda because a huge pharmaceutical is involved. For better or worse, they have more contacts.
Also, I doubt if GSK would have bothered paying for a med if they weren't pretty sure it would get a pass from the fda eventually.
Posted by jealibeanz on March 10, 2007, at 18:24:49
In reply to Re: GSK and Fabre-Kramer make agreement on Gepiron » Cecilia, posted by River1924 on March 10, 2007, at 18:01:37
> It was refused once. Besides newer clinical trials (I believe it was being tested as a treatment for atypical depression at one point), it will have a much better chance of passing the fda because a huge pharmaceutical is involved. For better or worse, they have more contacts.
>
> Also, I doubt if GSK would have bothered paying for a med if they weren't pretty sure it would get a pass from the fda eventually.True. Very true. Company name/establishment will make a big difference with the up and coming drugs for sure.
Posted by Ken Blades on March 12, 2007, at 5:56:22
In reply to Re: GSK and Fabre-Kramer make agreement on Gepirone ER, posted by jealibeanz on March 9, 2007, at 5:03:53
Effexor....>>>>>Then it made me so unemotional I had to remind myself to react appropriately to the outside world, otherwise I was content to stare at walls. That was the decided point of me quitting. I decided I would rather feel unhappy than feel nothing at all.<<<<<
My experience exactly....doesn't seem to be the most
common of Effexor side-effects; or am I not reading
the right threads?BuSpar and Wellbutrin....I had pretty much the same non-response...nothing good, nothing bad.
This is the end of the thread.
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