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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 Maria3667 on July 23, 2007, at 11:46:54
Hi everyone,
Does anyone know how long it takes the FDA to evaluate a new substance?
Fabre Kramer Pharmaceuticals REFILED it's application for Gepirone last May. Still no word on FDA approval/rejection. How many months does it take the FDA to reach a 'verdict'?
Posted by Phillipa on July 23, 2007, at 12:08:27
In reply to When is Gepirone approval due?, posted by Maria3667 on July 23, 2007, at 11:46:54
I think it varies deprending on what the drug is for. Love Phillipa
Posted by Maria3667 on July 23, 2007, at 16:25:56
In reply to Re: When is Gepirone approval due? » Maria3667, posted by Phillipa on July 23, 2007, at 12:08:27
> I think it varies deprending on what the drug is for. Love Phillipa
Hi Phillipa,
It's going to be marketed as an anti-depressant and may be as anti-anxiety agent too.
Posted by Phillipa on July 23, 2007, at 20:58:24
In reply to When is Gepirone approval due?, posted by Maria3667 on July 23, 2007, at 11:46:54
So it's gone through all the trial? Any group of ad's it will go in. It would be great for another classification. Think I'll see if it's on google. Love Phillipa
Posted by Phillipa on July 23, 2007, at 21:08:20
In reply to Re: When is Gepirone approval due? » Phillipa, posted by Maria3667 on July 23, 2007, at 16:25:56
This seems pretty old all I could find right now Love Phillipa
Organon to withdraw gepirone NDA: Organon is planning to withdraw the NDA for its antidepressant gepirone ER following the receipt of a second "not approvable" letter from FDA on June 23. The company submitted additional data in December 2003, and planned to market the drug as Variza. FDA's response likely relates to efficacy concerns, which were cited in the first "not approvable" letter in April 2002. Organon had been counting on gepirone (along with the contraceptive Implanon) as one of two major launches in 2004
Posted by Phillipa on July 23, 2007, at 21:16:03
In reply to Re: When is Gepirone approval due? » Phillipa, posted by Maria3667 on July 23, 2007, at 16:25:56
Better one. Love Phillipa
Gepirone. Organon
by
Leslie R A.
Addenbrooke's Centre for Clinical Investigation,
Cambridge, UK.
Ron_Leslie-1@gsk.com
Curr Opin Investig Drugs 2001 Aug;2(8):1120-7ABSTRACT
Gepirone, a pyridinyl piperazine 5-HT1A receptor agonist, has been developed by Fabre-Kramer as an antidepressant. Bristol-Myers Squibb (BMS) outlicensed the compound to Fabre-Kramer in 1993 and is no longer involved in its development [337393]. In May 1998, NV Organon (a subsidiary of Akzo Nobel) licensed the rights to the drug product for further development and marketing from Fabre-Kramer and, by October 1999, had submitted the drug for approval in the US [347133]. In December 2000, the company expected US and European launches in 2002 and 2003, respectively [402686]. Mechanism of action studies have demonstrated that gepirone, compared to buspirone, possesses a much greater selectivity for 5-HT1A receptors over dopamine D2 receptors. Long-term studies have shown that gepirone has a differential action at presynaptic (agonist) and post-synaptic (partial agonist) 5-HT1A receptors. However, further studies are still required to determine the relative contribution of pre- and post-synaptic 5-HT1A receptors to the therapeutic action of gepirone and related compounds. In March 2001, according to Schroder Salomon Smith Barney, Akzo Nobel targeted peak sales of Euro 300 million for gepirone [409013]. This amout was reiterated in an April 2001 report by HSBC Securities, which stated that gepirone was expected to achieve this figure in 2009 or 2010 [409014].
SSRIs
Posted by Maria3667 on July 24, 2007, at 3:42:03
In reply to Re: When is Gepirone approval due?, posted by Phillipa on July 23, 2007, at 21:08:20
Phillipa,
You are beating around the wrong bush.
Like I said in my initial post, they REFILED in May THIS YEAR after completing an additional set of trials.My question is: how long does it take the FDA to evaluate a new medicine from start to finish?
Here is some info:
http://www.medicalnewstoday.com/articles/70339.phpMy best,
Maria> This seems pretty old all I could find right now Love Phillipa
>
> Organon to withdraw gepirone NDA: Organon is planning to withdraw the NDA for its antidepressant gepirone ER following the receipt of a second "not approvable" letter from FDA on June 23. The company submitted additional data in December 2003, and planned to market the drug as Variza. FDA's response likely relates to efficacy concerns, which were cited in the first "not approvable" letter in April 2002. Organon had been counting on gepirone (along with the contraceptive Implanon) as one of two major launches in 2004
Posted by jrbecker76 on July 24, 2007, at 9:34:07
In reply to Re: When is Gepirone approval due? » Phillipa, posted by Maria3667 on July 24, 2007, at 3:42:03
Because it is being re-submitted, also known as a sNDA, the timeline the FDA has to respond is 6 mo from the FDA acceptance date (this is not always the same as the drug company's submission date since the FDA can sometimes take up to 1 month to accept an application). However, according to Fabre-Kramer/GSK, this roughly took place in May, so look for initial word in December. Of course, there is always the chance of further push-backs of the approval decision (e.g., "approvable" but not approved), but this is probably not likely with a sNDA submission. Once an approval takes place, it takes a pharm company approximately another 1-3 month to launch the drug. If you want to track progress on this situation, I would suggest you tune into GSK's quarterly reports/presentations for updates.
> Phillipa,
>
> You are beating around the wrong bush.
> Like I said in my initial post, they REFILED in May THIS YEAR after completing an additional set of trials.
>
> My question is: how long does it take the FDA to evaluate a new medicine from start to finish?
>
> Here is some info:
> http://www.medicalnewstoday.com/articles/70339.php
>
> My best,
> Maria
>
> > This seems pretty old all I could find right now Love Phillipa
> >
> > Organon to withdraw gepirone NDA: Organon is planning to withdraw the NDA for its antidepressant gepirone ER following the receipt of a second "not approvable" letter from FDA on June 23. The company submitted additional data in December 2003, and planned to market the drug as Variza. FDA's response likely relates to efficacy concerns, which were cited in the first "not approvable" letter in April 2002. Organon had been counting on gepirone (along with the contraceptive Implanon) as one of two major launches in 2004
>
>
Posted by Phillipa on July 24, 2007, at 9:42:02
In reply to Re: When is Gepirone approval due?, posted by jrbecker76 on July 24, 2007, at 9:34:07
Oh good you found more recent info that's great!!!! So December? Should be more info then? Or it will be released in December? Love Phillipa
Posted by Cecilia on July 24, 2007, at 13:37:24
In reply to When is Gepirone approval due?, posted by Maria3667 on July 23, 2007, at 11:46:54
Anyone think it will actually be approved? Cecilia
Posted by Maria3667 on July 25, 2007, at 8:23:15
In reply to Re: When is Gepirone approval due?, posted by jrbecker76 on July 24, 2007, at 9:34:07
Hi Jr,
Thanks for relaying this info to us. This is what I wanted to know. So in all fairness, if the approval goes through we could say that Gepirone is available on the US-market in approx Feb/March 2008??
My best,
Maria> Because it is being re-submitted, also known as a sNDA, the timeline the FDA has to respond is 6 mo from the FDA acceptance date (this is not always the same as the drug company's submission date since the FDA can sometimes take up to 1 month to accept an application). However, according to Fabre-Kramer/GSK, this roughly took place in May, so look for initial word in December. Of course, there is always the chance of further push-backs of the approval decision (e.g., "approvable" but not approved), but this is probably not likely with a sNDA submission. Once an approval takes place, it takes a pharm company approximately another 1-3 month to launch the drug. If you want to track progress on this situation, I would suggest you tune into GSK's quarterly reports/presentations for updates.
>
>
>
> > Phillipa,
> >
> > You are beating around the wrong bush.
> > Like I said in my initial post, they REFILED in May THIS YEAR after completing an additional set of trials.
> >
> > My question is: how long does it take the FDA to evaluate a new medicine from start to finish?
> >
> > Here is some info:
> > http://www.medicalnewstoday.com/articles/70339.php
> >
> > My best,
> > Maria
> >
> > > This seems pretty old all I could find right now Love Phillipa
> > >
> > > Organon to withdraw gepirone NDA: Organon is planning to withdraw the NDA for its antidepressant gepirone ER following the receipt of a second "not approvable" letter from FDA on June 23. The company submitted additional data in December 2003, and planned to market the drug as Variza. FDA's response likely relates to efficacy concerns, which were cited in the first "not approvable" letter in April 2002. Organon had been counting on gepirone (along with the contraceptive Implanon) as one of two major launches in 2004
> >
> >
>
>
Posted by Maria3667 on July 25, 2007, at 8:26:30
In reply to Re: When is Gepirone approval due?, posted by Cecilia on July 24, 2007, at 13:37:24
Hi Cecilia,
If a company decides to refile an application, it's usually because they are confident it will make it through.
I feel pretty confident about this one, eventhough I do realise a FDA rejection is always possible. Nevertheless, I'm very hopeful!
Maria
Posted by jrbecker76 on July 25, 2007, at 20:32:34
In reply to Re: When is Gepirone approval due? » jrbecker76, posted by Maria3667 on July 25, 2007, at 8:23:15
Well, I'm not sure how confident GSK is about approval. This quote is from today's GSK 2nd qtr presentation. It's not clear how pessimistic an outlook this is, and whether or not this refers to GSK's perspective on it or just financial analysts'.
"Gepirone ER has potential to be the first of a new class of antidepressants with no risk of sexual side effects or weight issues that many of the other antidepressants have. The FDA has accepted the file for review, and we'll know something by around November 2nd. While I don't think this is in many of the forecast models, this would be a nice upside if it's approved."
http://seekingalpha.com/article/42321> Hi Jr,
>
> Thanks for relaying this info to us. This is what I wanted to know. So in all fairness, if the approval goes through we could say that Gepirone is available on the US-market in approx Feb/March 2008??
>
> My best,
> Maria
>
> > Because it is being re-submitted, also known as a sNDA, the timeline the FDA has to respond is 6 mo from the FDA acceptance date (this is not always the same as the drug company's submission date since the FDA can sometimes take up to 1 month to accept an application). However, according to Fabre-Kramer/GSK, this roughly took place in May, so look for initial word in December. Of course, there is always the chance of further push-backs of the approval decision (e.g., "approvable" but not approved), but this is probably not likely with a sNDA submission. Once an approval takes place, it takes a pharm company approximately another 1-3 month to launch the drug. If you want to track progress on this situation, I would suggest you tune into GSK's quarterly reports/presentations for updates.
> >
> >
> >
> > > Phillipa,
> > >
> > > You are beating around the wrong bush.
> > > Like I said in my initial post, they REFILED in May THIS YEAR after completing an additional set of trials.
> > >
> > > My question is: how long does it take the FDA to evaluate a new medicine from start to finish?
> > >
> > > Here is some info:
> > > http://www.medicalnewstoday.com/articles/70339.php
> > >
> > > My best,
> > > Maria
> > >
> > > > This seems pretty old all I could find right now Love Phillipa
> > > >
> > > > Organon to withdraw gepirone NDA: Organon is planning to withdraw the NDA for its antidepressant gepirone ER following the receipt of a second "not approvable" letter from FDA on June 23. The company submitted additional data in December 2003, and planned to market the drug as Variza. FDA's response likely relates to efficacy concerns, which were cited in the first "not approvable" letter in April 2002. Organon had been counting on gepirone (along with the contraceptive Implanon) as one of two major launches in 2004
> > >
> > >
> >
> >
>
>
Posted by jrbecker76 on July 25, 2007, at 21:07:44
In reply to Re: When is Gepirone approval due? » Maria3667, posted by jrbecker76 on July 25, 2007, at 20:32:34
After reading this quote a few more times, I retract what I said in my last post (below). One thing is clear... GSK's quote on this issue is somewhat ambiguous. Here is the quote in question again...
"Gepirone ER has potential to be the first of a new class of antidepressants with no risk of sexual side effects or weight issues that many of the other antidepressants have. The FDA has accepted the file for review, and we'll know something by around November 2nd. While I don't think this is in many of the forecast models, this would be a nice upside if it's approved."
Rethinking it...this quote could mean that A) GSK and/or analysts are pessimistic on Gepirone's chances of approval OR B) this might refer to the fact that many analysts' forecast models have not included Gepirone in its potential earnings figures and that its approval would slightly boost them if it was approved. It's hard to know how to lean on this one. But I'll guess we'll know more in a few months.You can watch/view the GSK 2nd qtr presentation for yourself at GSK.com. The quote in question comes from slide #31.
http://events.ctn.co.uk/ec/gsk/361/protect/default.asp?
> Well, I'm not sure how confident GSK is about approval. This quote is from today's GSK 2nd qtr presentation. It's not clear how pessimistic an outlook this is, and whether or not this refers to GSK's perspective on it or just financial analysts'.
>
> "Gepirone ER has potential to be the first of a new class of antidepressants with no risk of sexual side effects or weight issues that many of the other antidepressants have. The FDA has accepted the file for review, and we'll know something by around November 2nd. While I don't think this is in many of the forecast models, this would be a nice upside if it's approved."
>
>
> http://seekingalpha.com/article/42321
>
Posted by Cecilia on July 26, 2007, at 22:41:20
In reply to Re: When is Gepirone approval due? » Cecilia, posted by Maria3667 on July 25, 2007, at 8:26:30
I hope your hopefulness proves right, Maria. We'll see. Some of the meds that people were eagerly awaiting on Psychobabble, like Reboxetine, disappeared, never to be heard of again. Others, Cymbalta and Emsam, eventually did appear, and in my case, after the long waits, proved to have no beneficial effects and even worse side effects than the old drugs. From what I'm read, Gepirone is pretty similar to Buspar, which certainly was no miracle drug (for me) but most likely I'll give it a try if it actually is approved. There's always that one in a million chance I suppose. Cecilia
Posted by Maria3667 on July 28, 2007, at 12:54:31
In reply to Re: When is Gepirone approval due?, posted by Cecilia on July 26, 2007, at 22:41:20
Hi Cecilia,
Know what you mean about being dissapointed.
Side effects have to be prooven by a larger audience than the participants in the clinical trials, in my opinion.
I know Gepirone is structurally related to Buspar, but from what I've read, because of a slight molecular difference it has a completely new mode of action. True or false? May be it's a fairy tale from a spin dr for the company? I'll gladly volunteer as a guinea pig and proove them right/wrong!
By the way, Reboxetine & Cymbalta are available in my country. However, I don't think Ensam has made it through yet. A friend of mine is eagerly awaiting the EMA's (the 'FDA' for the European Union) approval for Agomelatine, also a novel AD working on an an 5-HT2b antagonist, 5-HT2c antagonist, melatonin M1 receptor agonist and melatonin M2 receptor agonist. Agomelatonine is reported to have few or zero sexual side effects.
Keeping me of the streets this hobby of mine, tracking down new meds!
Cheers,
Maria> I hope your hopefulness proves right, Maria. We'll see. Some of the meds that people were eagerly awaiting on Psychobabble, like Reboxetine, disappeared, never to be heard of again. Others, Cymbalta and Emsam, eventually did appear, and in my case, after the long waits, proved to have no beneficial effects and even worse side effects than the old drugs. From what I'm read, Gepirone is pretty similar to Buspar, which certainly was no miracle drug (for me) but most likely I'll give it a try if it actually is approved. There's always that one in a million chance I suppose. Cecilia
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