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Dr. Bob is Robert Hsiung, MD,
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Posted by psychobot5000 on October 8, 2006, at 10:50:39
In reply to New FDA approvals: how long does this take?, posted by jealibeanz on October 8, 2006, at 8:03:38
According to what I've read, the prospects for approval for Gepirone and Valdoxan do not look good. Valdoxan was denied in the EU, and Servier had said other approvals depended on that process. I am disappointed. One article seemed to suggest that there was little reason Gepirone's application would be viewed differently the second time.
But PRX-00023's prospects look pretty good. Recently finished a stage III trial for anxiety, in which it failed to produce positive results that were large enough to be statistically acceptable--however, the secondary study results, on depression, were quite good. The developers said they planned to regear their approval strategy toward depression, and that was a week or two ago.
There are a bunch of other promising drugs a little further back in development. If you haven't been to this page, you should check it out. The information can be slightly outdated, but it's otherwise good.
http://www.neurotransmitter.net/newdrugs.html
> I know there are a few novel drugs in phase III for anxiety and depression:
>
> - Gepirone ER by Fabre-Kramer, is a 5-HT1A partial agonist, has completed phase III and has an amended NDA scheduled to be submitted in mid- 2006.
>
> - SR 58611 by Sanofi-Aventis, is a beta-3-adrenoceptor agonist, currently in Phase III.
>
> - Valdoxan (agomelatine, S-20098)by Novartis, is a 5-HT2C antagonist, 5-HT2B antagonist, melatonin M1/M2 receptor agonist, currently in Phase III.
>
> - Saredutant(SR 48968), a NK2 antagonist, by Sanofi-Aventis, is currently in Phase III.
>
> - PRX-00023 5-HT1A agonist, sigma receptor antagonist. by Predix, is currently in Phase III for ADHD and anxiety(still in phase II for depression).
>
> I'm sure there are more, but these are the only ones I've come across at this time. It's so difficult to get concrete information!
>
> Anyway, I'm wondering how long it would be expected for any of these medications to be approved and put on the market. I realize this process is slowed when the FDA reviews an application, and then asks for further studies to be done. Assuming we have a perfect world (HA!), and this does not happen, how long does it usually take for phase III drugs to be approved?
>
> I'm especially interested in Gepirone since it has actually completed phase III, submitted an NDA initially, then was asked to provide further information. They now appear to be in the process of submitting their 2nd NDA. I believe it has been submitted at this time, although I could be incorrect.
>
> I don't know that this particular drug would be my best bet, but who knows. They claim to have few side effects (sexual, weight, apathy, lethargy) in comparison to SSRI's (yay! people are actually admitting the SSRI's are not all they're cracked up to be!). However, this appears to be the only hope within the next year or so.
>
>
Posted by bassman on October 8, 2006, at 12:59:49
In reply to Re: Valdoxan, gepirone, prx00023, posted by psychobot5000 on October 8, 2006, at 10:50:39
12-15 months is really fast-I'm afraid three years isn't uncommon, esp. for psychoactive drugs. If there are anti-cancer drugs, no matter how ineffective, they'll get priority in terms of review. But it's just luck-what else is being reviewed, how happy the reviewers are that day, whether everyone has done a good job on their studies and the Feds need little more info, etc. If it is seen as a "me-too" drug, it might increase the review process, too.
I'm really amazed that better AD's haven't been developed-it would seem to be such a lucrative market and the efficacy of available meds is very lacking. Dunno.
Posted by yxibow on October 8, 2006, at 14:53:21
In reply to more recent data (same times) » pseudoname, posted by pseudoname on October 8, 2006, at 10:20:51
> More recent page: http://www.fda.gov/cder/rdmt/NDAapps93-05.htm
>
> Same time frames, 12-15.4 months.
>
> I don't know what it takes to get a drug rated "Priority", which cuts the time down to 6 months.Priority drugs are those that can fit in several categories, often "orphan drugs", which are drugs that will only benefit a small segment of the population. Usually vaccines, protease inhibitors, and chemotherapy medications.
Posted by jealibeanz on October 8, 2006, at 15:02:28
In reply to Re: Valdoxan, gepirone, prx00023, posted by psychobot5000 on October 8, 2006, at 10:50:39
Yeah, that's where I got my information from.
Posted by jealibeanz on October 8, 2006, at 15:05:43
In reply to 12-15 months after studies are done? » jealibeanz, posted by pseudoname on October 8, 2006, at 9:59:58
This surprises me. The only currently approved drug I followed was EMSAM. It seems that once that had their finaly NDA submitted it did not take that long. Gerpirone is on their 2nd application I believe, which provide more evidence of its efficacy.
Posted by jealibeanz on October 8, 2006, at 15:11:28
In reply to Re: more recent data (same times), posted by Phillipa on October 8, 2006, at 10:33:02
Phillipa! Stop being sooo negative about EMSAM, sweety! You haven't even tried it! I know you've heard some bad reports, but also some good ones. You have to remember that the people poasting on this board only represent a very small percentage of the patients taking this medication. The people who tend to post here are the ones who are not doing so well. Those who are happy with their medication are moving on with their lives and not searching for another cure.
I know I also am fixated on the drug, but I'm trying to look at it in a positive, hopeful manner!
If you don't believe in it, than there's very little chance it will work for you. The mind is a powerful thing.
Posted by jealibeanz on October 8, 2006, at 15:13:16
In reply to Re: New FDA approvals: how long does this take?, posted by jealibeanz on October 8, 2006, at 8:32:25
So what do you all think about my plan to approach my doctor in this manner? Any suggestions?
Posted by bassman on October 8, 2006, at 15:20:41
In reply to Re: more recent data (same times) » pseudoname, posted by yxibow on October 8, 2006, at 14:53:21
I was wrong...shows the last time the company I was working for submitted an NDA! :>} 12-15 months is realistic today-the better part of 3 years was in the past.
Posted by pseudoname on October 8, 2006, at 15:29:49
In reply to Re: more recent data (same times) » pseudoname, posted by yxibow on October 8, 2006, at 14:53:21
Thanks, Jay. I just found this:
<quote>
A Priority designation is intended for those products that address unmet medical needs.The drug product, if approved, would be a significant improvement compared to marketed products […]. Improvement can be demonstrated by, for example: (1) evidence of increased effectiveness in treatment, prevention, or diagnosis of disease; (2) elimination or substantial reduction of a treatment-limiting drug reaction; (3) documented enhancement of patient compliance; or (4) evidence of safety and effectiveness of a new subpopulation.
The priority determination does not take into consideration any information or estimate of price and is based on conditions and information available at the time the application is filed. It is not intended to predict a drug’s ultimate value or its eventual place in the market.
<unquote>[Also, drugs can change mid-evaluation from "Priority" to "Standard".]
• http://www.fda.gov/cder/mapp/6020-3.pdf
It seems like anything but a me-too drug should get Priority, under those definitions. And there's also Fast Track, which is completely different process, and Accelerated Approval, which I have no idea what is.
Posted by pseudoname on October 8, 2006, at 15:32:19
In reply to Re: more recent data (same times), posted by bassman on October 8, 2006, at 15:20:41
> I was wrong...shows the last time the company I was working for submitted an NDA! :>} 12-15 months is realistic today-the better part of 3 years was in the past.
That's good!
BTW, is it "baassman" like the fish or "baseman" like the singer??
Posted by bassman on October 8, 2006, at 16:37:45
In reply to good » bassman, posted by pseudoname on October 8, 2006, at 15:32:19
That's funny! Actually, it's "bassman" like a person who plays the electric bass guitar. Maybe I should say, "tries to play the bass guitar" (I think I have the folks in my band fooled, and that's all that counts! :>}) What's funny is that my wife and I went over a bridge in NH and the name of the river was "Bass River"...and so I mumbled "Bass (bay-suh) River" and my wife said, "uh, I think that is Bass (bah-suh) River". All of Life is perspective...
Posted by pseudoname on October 8, 2006, at 16:47:32
In reply to Good plan for me?, posted by jealibeanz on October 8, 2006, at 15:13:16
> So what do you all think about my plan to approach my doctor in this manner? Any suggestions?
You mean, suggestions for getting him to up your Xanax dose? Or, suggestions about dealing with increasing anxiety? If the former, it (almost) never hurts to ask. However…
He MAY be more easily persuaded if he knows that you are also doing other things to deal with anxiety and not trying to completely rely on his narcotics. Like, using exercise before and mindful attention during anxious periods. Show him the CBT- or meditation-type book you're using (and if you're not, you could get one) and tell him how hard you're working in these other ways. That may reassure him a little, and loosen his prescription pen. (And if not, it might help on its own; no guarantees.)
Good luck. Post how it goes.
Posted by Phillipa on October 8, 2006, at 17:50:38
In reply to Re: more recent data (same times), posted by jealibeanz on October 8, 2006, at 15:11:28
Jelly where did that come from. But thanks I know what you say is true . And unfortunately my mind is too powerful. But I'm working on that. That's one of the reasons I'm so obsessive about the data. The more times I hear good things the more courage I get. I wish there were some stats on how many people are doing well? Love Phillipa
Posted by jealibeanz on October 8, 2006, at 17:57:47
In reply to Re: Good plan for me? » jealibeanz, posted by pseudoname on October 8, 2006, at 16:47:32
I was asking about how to talk to my doctor about my concern of taking Xanax, but conveying that it is improving the quality of my life at the moment. And yes, I would like to increase a little, or switch to XR, or something that would help with anxiety!
If he ever brings up the idea of tryyying an SSRI, since they're all slightly different, I'll tell him flat out that I'd rather take absolutely nothing than go that route. We both know that I would not last very long at school without medication and eventually dropout. Neither of us would like that to happen.
I've been unmedicated for anxiety for the majority of the time that I've had it. I know what it's like. I can live with it. But it would be a low quality, underachieving life, no doubt.
I do exercise, whenever I can. I love it. Actually if he asks, I will tell him that I try to exercise a few days a week, however, sometimes, once I start, I need to stop because my anxiety is so bad that my muscles are all tight and I can't comfortably continue!
I do have CBT tapes and a workbook that I'm completing. I've done biofeedback therapy in the past, which is not an option right now, since that machine was borrowed from a friend and costs about $3000!
The dean of my program referred me to a counselor on campus when she was aware of the fact that I was have anxiety and insomnia problems. I'm just not comfortable with talk therapy right now and have never found it beneficial in the past. I know some swear by it, but if I'm not 100% sold on the idea, then me forcing myself to go is simply a waste. We need to believe in our treatments.
Despite the fact that I've indicated how difficult and demanding my academics are, I'm at a verrry supportive school. They make it as relaxed and low-key as possible, without hindering our education. The faculty act like parents rather than professors. They are always on the lookout for someone who needs help.
So, I am doing the best I can with my situation, I just need some augmentation with meds!
Posted by jealibeanz on October 8, 2006, at 18:00:41
In reply to Re: more recent data (same times) » jealibeanz, posted by Phillipa on October 8, 2006, at 17:50:38
This was already posted, but here it is again:
Posted by Phillipa on October 8, 2006, at 18:46:18
In reply to Re: more recent data (same times) » Phillipa, posted by jealibeanz on October 8, 2006, at 18:00:41
Thanks Jelly is effexor really good for anxiety? Thought it had all those liver problems? Love Phillipa
Posted by Phillipa on October 8, 2006, at 18:47:51
In reply to Re: more recent data (same times) » Phillipa, posted by jealibeanz on October 8, 2006, at 18:00:41
I mean that sounds like effexor is better for anxiety than EMSAM? Love Phillipa
Posted by jealibeanz on October 8, 2006, at 19:14:40
In reply to Re: more recent data (same times), posted by Phillipa on October 8, 2006, at 18:47:51
Liver problems? I'm not sure about this. If you have liver disease then maybe that would be an issue.
I took Effexor XR for 7 weeks. Well... as for anxiety, I suppose it helped, in the fact that I was completely apathetic and felt no emotions whatsoever. Oh, and I was completely nauseous, couldn't eat a thing, and gained 20 lbs.
So, my opinion of Effexor is poor, but you may do well since you've done well on SSRI's. I have not. You are not me. I'm sure you'd have a very different reaction. Some people do very well. It's known as a great antidepressant. It definitely pulled me out of a major depression, I just didn't care to continue with it.
You need to trust you doctor's plan. If it's not helping, let that be known. The two of you can come up with another option. If your doctor isn't helping, find a new one.
Posted by Phillipa on October 8, 2006, at 19:28:59
In reply to Re: more recent data (same times), posted by jealibeanz on October 8, 2006, at 19:14:40
No ad that I've taken has ever worked for me except l0mg of paxil with lopressor and xanax and beer. So I'm at a loss. As only 30 to 50% of people respond to antidepressants. Guess I'm one. I can tolerate low doses of luvox that's it. Love phillipa
Posted by psychobot5000 on October 8, 2006, at 20:44:11
In reply to Re: more recent data (same times), posted by Phillipa on October 8, 2006, at 18:47:51
I know a female in her twenties, who took selegiline/EMSAM (quarter patch's worth), and had reduced anxiety and mildly elevated mood--at a quarter dose. Her reaction was pretty quick--a few days. Just imagine if she'd taken a normal dose.
Now she finds she doesn't need it any more. Yay!
Posted by Phillipa on October 8, 2006, at 21:24:10
In reply to Re: more recent data (same times) » jealibeanz, posted by Phillipa on October 8, 2006, at 19:28:59
Thank-you so much that is highly encouraging. Now the decision cut out luvox for EMSAM or up to luvox. Help Love Phillipa
Posted by psychobot5000 on October 8, 2006, at 21:41:58
In reply to Re: more recent data (same times) » Phillipa, posted by Phillipa on October 8, 2006, at 21:24:10
I know nothing about Luvox, other than its drug class. MAOi experts, as far as I know, think you can combine MAO-b inhibitors with SSRIs, at least cautiously.
Doctor might be wary of it, but it makes sense--EMSAM, at least at 6mg and below, effects dopamine almost exclusively. Luvox should effect mostly serotonin, right? They would -seem- to be safe together, and I know expert docs use all of the old tricyclics except clomipramine with the unselective MAOis.
Could try EMSAM alone first, so you know what its effects are alone, and then add the SSRI back in if you need it.
Good luck!
Posted by Phillipa on October 8, 2006, at 21:51:03
In reply to Re: EMSAM Luvox » Phillipa, posted by psychobot5000 on October 8, 2006, at 21:41:58
Ahh you're a sweetie but she said I had to be ad free for two weeks first. So was thinking stay at 25mg and maybe go down to l2.5mg see how I feel and then if okay discontinue and wait the two weeks. Love Phillipa
Posted by jealibeanz on October 9, 2006, at 3:48:27
In reply to Re: more recent data (same times), posted by psychobot5000 on October 8, 2006, at 20:44:11
Really? I cant imagine stopping something that works!
Posted by saturn on October 9, 2006, at 14:10:18
In reply to New FDA approvals: how long does this take?, posted by jealibeanz on October 8, 2006, at 8:03:38
It's good that you have hope.
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