Psycho-Babble Medication Thread 977653

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Re: New FDA Approval for MDD Viibyrd (Vilazodone)

Posted by morgan miller on January 23, 2011, at 15:21:23

In reply to Re: New FDA Approval for MDD Viibyrd (Vilazodone), posted by bearfan on January 23, 2011, at 14:31:40

> Viibyrd's unique method of action is what mitigates the weight gain and sexual side effects. Even if it doesn't work quite as well as some of the existing treatments, if the weight gain and sexual side effects are truly clinical less, I'd be glad to make the switch.

I believe if one is disciplined enough, there are ways to at least take care of the weight gain issue for most people. The sexual side effects may be a more difficult obstacle to overcome.

I wonder if someone is in great shape, eats great, and loses weight, they might also regain some of their sex drive. Just a thought.

 

Re: New FDA Approval for MDD Viibyrd (Vilazodone)

Posted by linkadge on January 23, 2011, at 15:35:43

In reply to Re: New FDA Approval for MDD Viibyrd (Vilazodone), posted by bearfan on January 23, 2011, at 14:31:40

>Viibyrd's unique method of action is what >mitigates the weight gain and sexual side >effects.

purportedly

Linkadge

 

Re: New antidepressant just approved. Vilazodone

Posted by digger7 on January 25, 2011, at 6:31:55

In reply to Re: New antidepressant just approved. Vilazodone » Conundrum, posted by SLS on January 22, 2011, at 20:30:38

What would be the ideal antidepressant if the F.D.A would approve it?
RJR7

 

Re: New antidepressant just approved. Vilazodone

Posted by ed_uk2010 on January 25, 2011, at 13:43:09

In reply to Re: New antidepressant just approved. Vilazodone, posted by digger7 on January 25, 2011, at 6:31:55

> What would be the ideal antidepressant if the F.D.A would approve it?

At the moment, no such product exists.

 

Re: New FDA Approval for MDD Viibyrd (Vilazodone)

Posted by bearfan on January 25, 2011, at 16:22:37

In reply to Re: New FDA Approval for MDD Viibyrd (Vilazodone), posted by linkadge on January 23, 2011, at 15:35:43

I audited a presentation from Clincial Data and big name investors (WeedBush etc.). The folks at Clinical Data seemed very happy (almost elated) at the potential of this drug. From the conversation, a big strong point was the tolerability with lack of cardio and hepatic side effects. Weight gain and sexual dysfunction was also not apparent. My guess is the efficacy is near or possibly lower than some existing treatments, but can be useful for patients in a more stable period who wish to drop side effects for a medicine less strong. Cymbalta and Lexapro go off-patent in a year or two and the new approval will give it patent protection for quite some time.

 

Re: New antidepressant just approved. Vilazodone

Posted by Cecilia on January 26, 2011, at 3:16:52

In reply to New antidepressant just approved. Vilazodone (nm), posted by roscopeeco on January 22, 2011, at 2:07:52

From the information I have been able to find, Vilazodone sounds like a combination of an SSRI and buspirone (a combination many of us have tried without astounding results). Anyone know if this true or are there any other differences that make it worth considering? I just wish the drug companies would actually do some research on new drugs, instead of tweaking the old ones to increase their profits!

 

Re: New antidepressant just approved. Vilazodone

Posted by bearfan on January 26, 2011, at 15:35:44

In reply to Re: New antidepressant just approved. Vilazodone, posted by Cecilia on January 26, 2011, at 3:16:52

I don't think it's just that simple. Many people can't tolerate Buspar or SSRIs for that matter. The Partial agonist property is what helps prevent the bad side effects like weight gain and sexual dysfunction. There was just a conference with clinical data and investment firms and the folks that developed the drug were glowing with enthusiasm. I am sure they are aware with the clinical trial studies and know the potential of this medication. I have a hunch that Viibryd will be on par with existing SSRIs (with regards to efficacy) but a much less incidence of serious side effects. That being the case, this drug has big potential as a 1st line treatment. Plus there is always augment options for people not getting enough of an effect.

 

Re: New antidepressant just approved. Vilazodone

Posted by Cecilia on January 28, 2011, at 23:42:14

In reply to Re: New antidepressant just approved. Vilazodone, posted by bearfan on January 26, 2011, at 15:35:44

Yes, half the stuff I've been able to find on google about it is about the financial advantages the drug company and investors are hoping to gain from it now that most other AD's have gone generic. They didn't think it would be approved so quickly and are thrilled with the potential profits. What I haven't been able to find anything about is how exactly it is different from other SSRI's. Maybe the added partial agonist property will prevent some side effects but I'm sure there are plenty of other side effects still to be discovered. I've tried so many useless meds, just would like to know what there is, if anything, about this one that is different enough to make it worth trying.

 

Re: New antidepressant just approved. Vilazodone

Posted by Cecilia on January 29, 2011, at 1:47:19

In reply to Re: New antidepressant just approved. Vilazodone, posted by Cecilia on January 28, 2011, at 23:42:14

Plus there were only 400 patients in the study. That seems unbelievable to me. Do most drug studies have such a small number of patients? With half of them in the placebo group that means only about 200 got the actual drug. I don't understand the FDA; they will turn down a drug that's been safely used in other countries for many years with many thousands of patients and then turn around and approve a drug that was only tried on 200 people. Makes no sense to me.

 

Re: New antidepressant just approved. Vilazodone

Posted by 49er on January 29, 2011, at 9:30:05

In reply to Re: New antidepressant just approved. Vilazodone, posted by Cecilia on January 26, 2011, at 3:16:52

Personally, I would be very skeptical as if you all recall, Prozac was supposed to be side effect free and the new wonder drug. It didn't happen for many people.

This isn't an issue of being pro-meds vs. anti-meds as I have this skepticism with all meds. Eight weeks isn't nearly enough time to be able to test thoroughly for all side effects and efficiency.

Personally, if I were still taking psych meds, I wouldn't touch it for a few years just to see what problems people had that I should be concerned about.

Obviously, your mileage will vary.

49er

 

Re: New antidepressant just approved. Vilazodone

Posted by bearfan on January 30, 2011, at 0:39:46

In reply to Re: New antidepressant just approved. Vilazodone, posted by Cecilia on January 29, 2011, at 1:47:19

This is incorrect; based on the studies from clinicaltrials.gov/, nearly 3,000 patients participated in the trial with a year of drug exposure.

 

Marketing

Posted by ed_uk2010 on January 30, 2011, at 13:24:44

In reply to New FDA Approval for MDD Viibyrd (Vilazodone), posted by bearfan on January 22, 2011, at 17:29:40

I suspect that vilazodone is going to be promoted extensively based on the alleged absence of weight gain and sexual side effects. To what extent these adverse effect occur in the real world remains to be seen. SSRIs were initially advertised as causing zero weight gain, but we now know that some patients do gain weight during long term treatment. Rates of reported sexual side effects were often quite low during SSRIs trials, which is in contrast to the real world experience with these drugs. I don't think patients were correctly assessed for these side effects.

 

Re: Marketing » ed_uk2010

Posted by phillipa on January 30, 2011, at 19:09:57

In reply to Marketing, posted by ed_uk2010 on January 30, 2011, at 13:24:44

Ed trials only weeks long. PJxx

 

Re: Marketing

Posted by rogerk on January 31, 2011, at 1:51:24

In reply to Re: Marketing » ed_uk2010, posted by phillipa on January 30, 2011, at 19:09:57

trazodone is an easy go to sleeping helper. but for what it lacks in is the cadiovascular side effects. it doesn't affect you're weight too much, or sexually too much.

but it would always affect my heart.

hopefully, vilazodone, is in this aspect better than the old ones of serzone and the others. and being an antidepressant would help for sleepl.

 

Re: Vilazodone Marketing

Posted by bearfan on January 31, 2011, at 15:38:21

In reply to Marketing, posted by ed_uk2010 on January 30, 2011, at 13:24:44

Ed while you are correct, based on the Viibryd prescribing information, unlike the older SSRI trials, patients for Viibryd were asked to participate in the ASEX experience study and it was shown to be almost insignificant compared to placebo. Based on what I've read, the side effects (both short and long term) seem to be mild, my only question is what the efficacy is really in the real world. I remain cautiously optimistic. Although the nice thing is that this is a new compound, not like the last decade where there have been many reformulations or derivatives of the same compound.

 

Re: Vilazodone Marketing » bearfan

Posted by ed_uk2010 on January 31, 2011, at 16:08:44

In reply to Re: Vilazodone Marketing, posted by bearfan on January 31, 2011, at 15:38:21

> Ed while you are correct, based on the Viibryd prescribing information, unlike the older SSRI trials, patients for Viibryd were asked to participate in the ASEX experience study and it was shown to be almost insignificant compared to placebo. Based on what I've read, the side effects (both short and long term) seem to be mild, my only question is what the efficacy is really in the real world. I remain cautiously optimistic. Although the nice thing is that this is a new compound, not like the last decade where there have been many reformulations or derivatives of the same compound.

I'm interested too.... are you wondering whether mild adverse effects might equal weak efficacy?

 

Re: Vilazodone Marketing » bearfan

Posted by ed_uk2010 on January 31, 2011, at 16:09:17

In reply to Re: Vilazodone Marketing, posted by bearfan on January 31, 2011, at 15:38:21

> Ed while you are correct, based on the Viibryd prescribing information, unlike the older SSRI trials, patients for Viibryd were asked to participate in the ASEX experience study and it was shown to be almost insignificant compared to placebo. Based on what I've read, the side effects (both short and long term) seem to be mild, my only question is what the efficacy is really in the real world. I remain cautiously optimistic. Although the nice thing is that this is a new compound, not like the last decade where there have been many reformulations or derivatives of the same compound.

I'm interested too.... are you wondering whether mild adverse effects might equal weak efficacy?

........at least at the recommended dose.

 

Re: Vilazodone Marketing

Posted by bearfan on January 31, 2011, at 16:38:00

In reply to Re: Vilazodone Marketing » bearfan, posted by ed_uk2010 on January 31, 2011, at 16:09:17

No, its more of there not being much data with head to head studies. Viibryd was only compared to Citalopram (Celexa) and Placebo. All released data seems to point to high tolerability, but not a whole lot on efficacy other than the HAM-D. I think Viibryd may be more of a trade-off drug; much in the way of Lexapro. It may have much lower side profile, but the efficacy seems to be rather unproven until its released and we have some real life testimony.

 

Re: Vilazodone Marketing

Posted by Phillipa on January 31, 2011, at 19:33:46

In reply to Re: Vilazodone Marketing, posted by bearfan on January 31, 2011, at 16:38:00

I've read on another board that it's milder and true about the sex and leads to better sleep by those taking it. Phillipa

 

Viibryd Approved; works on Serotonin and Dopamine

Posted by bearfan on February 1, 2011, at 20:18:03

In reply to Re: New antidepressant just approved. Vilazodone, posted by bearfan on January 30, 2011, at 0:39:46

Found a new article, apparently it also has some kind of mechanism on increasing dopamine. This may be the reason why it tends to have less sexual side effects. Perhaps the agonist or other unique property causes an increase in dopamine indirectly. A lot of people are automatically counting out Viibryd, but it seems to have enough going for it to give it a try.

http://www.aolhealth.com/2011/01/27/new-antidepressant-fewer-side-effects/

 

Re: New antidepressant just approved. Vilazodone

Posted by bodhisattva_guy on February 4, 2011, at 23:40:18

In reply to Re: New antidepressant just approved. Vilazodone, posted by Cecilia on January 29, 2011, at 1:47:19

Where are you guys getting false info that this medication impacts dopamine receptors?
Please, do not jump to share your knowledge (as helpful as it is to others) until you are sure it is valid. Do not take it personally - just read up more before posting.

Here is an excerpt from quite detailed article about this drug's development and psycho pharmacological profile. It points out that no dopamine receptors are activated by this drug, while also clearing up some other misstatements.


Tommy

You can view the pdf version here:
www.biomedcentral.com/content/pdf/cd-768430.pdf

or plain html here:
http://webcache.googleusercontent.com/search?q=cache:I7q1-RMGx5YJ:www.biomedcentral.com/content/pdf/cd-768430.pdf+vilazodone+receptors+dopamine&hl=en&gl=us

Structural modifications of this series to
maximize affinity for both the serotonin transporter and the
5-HT1A receptor, and to minimize affinity for dopamine
receptors, resulted in the creation of vilazodone [741693].
Thus, vilazodone was designed specifically to have potent
dual activity both as an SSRI and a 5-HT1A receptor agonist
without interaction with other neurotransmitter transporters
or receptors, thereby reducing side effect liability [245884].
Originally developed by Merck KGaA and later by
GlaxoSmithKline plc [399224], vilazodone is licensed to
Genaissance Pharmaceuticals Inc (a subsidiary of Clinical
Data Inc), which is currently developing this agent via
Precigen Therapeutics Inc (another subsidiary of Clinical
Data) [627525], [667315

 

Re: New antidepressant just approved. Vilazodone

Posted by bodhisattva_guy on February 4, 2011, at 23:49:46

In reply to Re: New antidepressant just approved. Vilazodone, posted by mrtook on January 23, 2011, at 13:01:05

NO, this is not same as buspar, reasong being:
"Buspirone functions as a serotonin 5-HT1A receptor partial agonist.[6] It is this action that is thought to mediate its anxiolytic and antidepressant effects. Additionally, it functions as a dopamine D2, as well as α1, and α2-adrenergic receptor antagonist to a lesser degree, though these properties are generally undesirable in an anxiolytic and likely only contribute to side effects." [wikipedia]

My other post gives details as to why this drug is lacking dopamine activity.

> So this med is similar to taking an SSRI and buspar together? I think some people have results with this.
>
> MrTook

 

Re: Viibryd Approved; works on Serotonin and Dopamine

Posted by bodhisattva_guy on February 4, 2011, at 23:59:37

In reply to Viibryd Approved; works on Serotonin and Dopamine, posted by bearfan on February 1, 2011, at 20:18:03

This medication has no effect on dopamine receptors. You are making an assumption - since this medication belong to "new group of medications, which might help by having affinity (binding) to dopamine". Stop making assumptions and read articles found on http://scholar.google.com/ or pubmed.com

Respectfully,

Tommy

 

Re: Viibryd Approved; works on Serotonin and Dopamine

Posted by bodhisattva_guy on February 5, 2011, at 0:19:58

In reply to Re: Viibryd Approved; works on Serotonin and Dopamine, posted by bodhisattva_guy on February 4, 2011, at 23:59:37

Well, it's quite complex, so I will add additional info from the article mentioned above:

"However, the effects for pindolol have not been observed with vilazodone. In the same PET clinical trial, vilazodone
exhibited twice the receptor occupancy in the midbrain raphe nucleus, a small beaded structure with high concentrations of presynaptic 5-HT1A
autoreceptors, compared with occupancy in cortical areas [688282]. Consistent with the action of a selective 5-HT1A receptor
agonist, such as 8-OH-DPAT, marked increases in dopamine and norepinephrine neurotransmission would be expected [742319]. However, this effect on dopamine or norepinephrine was not produced by vilazodone"

Another, older article,

"Neurochemical evaluation of the novel 5-HT1A receptor partial agonist/serotonin reuptake inhibitor, vilazodone
by
Hughes ZA, Starr KR, Langmead CJ, Hill M,
Bartoszyk GD, Hagan JJ, Middlemiss DN, Dawson LA.
Neuropharmacology Research,
Psychiatry CEDD, Glaxo Smith Kline,
New Frontiers Science Park,
Third Avenue, Harlow, Essex, CM19 5AW, UK.
Eur J Pharmacol. 2005 Mar 7;510(1-2):49-57.

ABSTRACT

Vilazodone has been reported to be an inhibitor of 5-hydoxytryptamine (5-HT) reuptake and a partial agonist at 5-HT1A receptors. Using [35S]GTPgammaS binding in rat hippocampal tissue, vilazodone was demonstrated to have an intrinsic activity comparable to the 5-HT1A receptor agonist 8-hydroxy-2-(di-n-propylamino)tetralin (8-OH-DPAT). Vilazodone (1-10 mg/kg p.o.) dose-dependently displaced in vivo [3H]DASB (N,N-dimethyl-2-(2-amino-4-cyanophenylthio)benzylamine) binding from rat cortex and hippocampus, indicating that vilazodone occupies 5-HT transporters in vivo. Using in vivo microdialysis, vilazodone (10 mg/kg p.o.) was demonstrated to cause a 2-fold increase in extracellular 5-HT but no change in noradrenaline or dopamine levels in frontal cortex of freely moving rats"

Please do not be disturbed by detailed back up of my personal opinion, but since this is a new medication, medical literature excerpts should only help to educate those considering trying this medication. From the molecular structure of common SSRIs like paroxetine or fluoxetine, the chemical structure is definitely quite different, so I am hoping this has some hope. As far as "teleconference with marketers" - please, understand, they are paid to present their findings via utmost optimistic manner. If I was about to sell new antidepressant, during the teleconference with the marketers and shareholders, I would also sound very optimistic, pointing out how good this medication is.
Is the "best drug so far " or not, let's wait another week or two until someone tries it and posts their experience, and then maybe another year or two to see how they are holding up.

 

Re: Viibryd Approved; works on Serotonin and Dopamine

Posted by bearfan on February 6, 2011, at 18:47:26

In reply to Re: Viibryd Approved; works on Serotonin and Dopamine, posted by bodhisattva_guy on February 5, 2011, at 0:19:58

I found another article on Viibryd. Also it's important that drugs that work on NE and DA don't always mean that they are better. Many times NE and DA drugs make me tired.

http://seekingalpha.com/instablog/574923-pslice84/134219-clda-piper-jaffray-why-viibryd-could-be-a-blockbuster-why-a-novel-moa-matters-in-depression-important-sexual-side-effect-benefit-potential-partners-will-value-viibryd-as-a-potential-blockbuster-outperform


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