FDA approves Vraylar / Cariprazine to treat schizophrenia and bipolar disorder

The U.S. Food and Drug Administration today approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm463103.htm

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Side effects from the article:

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Omg yay!!! I’m going to ask my doctor about this.

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Wow - when does it hit pharmacies?

I am going to keep my eye on this drug, as it is also approved for bipolar disorder - Rexulti is not.

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the FDA will approve anything, they are in the pockets of the pharmaceutical companies…keep shoving dangerous drugs down our throats please FDA…dont approve CBD meds oh no that might be good for you…

I wouldn’t jump straight for it, I bet money it isn’t the miricle cure. When I went on abilify I thought it would cure all my problems and it was just the same ā– ā– ā– ā–  different name.

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No antipsychotic is a miracle cure… but I am looking for a safer alternative to Risperdal.

At this point I am just going to see how well it does, no decision on my part yet.

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It was initially rejected in 2013. http://www.fiercebiotech.com/story/allergan-and-richter-win-fda-approval-once-rejected-schizophrenia-pill/2015-09-17

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Good find. Looks like it was ā€œjustā€ rejected as more data was needed to find the therapeutic dose. Not on any other grounds.

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Yes, treatment for negative symptoms !!! :grin:

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I’m so happy, this is the most positive news in a wile - Seems a lot of people are struggling still with their level of negative symptoms despite being on consistent doses of anti psychotics

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Any idea when this will be marketed and available over there [US] ?

I am still waiting for ITI-007. This drug has too many side effects in my book, and all I want is a drug that does what my current drug does without the side effects. Encenicline is looking more grim with its gastric intestinal problems in the dementia phase 3 trial.

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If you read the prescribing information sheet it states percentages. Baring in mind that if ONE person writes to a pharmaceutical company explaining a side effect incurred due to ingestion of their product then they legally have to list it, you’re not gonna suffer them all or even many.

It’s by no means a shining light in eradicating Bipolar and/or Schizophrenia but it seems an improvement on the current options, it’s hope - Which we all seem to need at some point

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Show me the full stats on the phase 3 trial and I’ll decide that for myself. I am pretty sure if they list it as a common symptom, it is a clinically significant one compared to placebo. I also want a comparison chart between it and risperdal, because although it may be good treating negative symptoms, doesn’t mean it is good at treating positive ones. BTW you do realize there was a suicide in the phase 3 trial right? But according to the ā€œexpertsā€ this was not due to the med itself. How exactly they determined that, I have no idea, unless the person had a wife and kids hit by a bus.

Wow. I’ve just googled iti-007, it seems too good to be true.

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Yeah, what I thought too.

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I give a link to the best presentation on the medication ITI-007 in this thread (with graphs):

The admin said the link is legit, which is why I am linking to the thread and not the direct link. Basically their philosophy while developing the med was that there is a major non-compliance issue and so they wanted to develop a medication that addressed the horrific side effects with current antipsychotics, as well as other issues.

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ITI-007 looks really good. Will talk to my pdoc about this, maybe he knows about it.

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Understandable in your desire to want a comparison, but I really don’t understand the level of scepticism without actively looking at the statistics involved. It’s not my job to do your research for you, I’ve seen the stats and they look impressive when levied against the current odds of side effects. As someone who has VERY LITTLE in the way of them, I’d gladly take more if it meant a decline in my symptoms.

My current dose of Olanzapine suggests I have a [less than one percent] chance of incurring a ā€˜painful erection lasting up to six hours’ - The art of the law of averages is that SOME people will fall victim to certain side effects that others don’t - Your theory seems to promote a refusal to try without clarity when, in most patients, medication has a differing effect based on a variety of moving parts specific to their illness.

The suicide LINK is irrelevant in the sense that apportioning blame to the medication would be purely speculative - For someone so keen on ascertaining the ā€˜ā€˜facts’’ of the new medication it seems somewhat contradictive to revert to such a speculative stance. People with scz have a ridiculously high suicide rate in comparison to many other illnesses. Let’s just assume everyone who CHOOSES to take their own life has done so due to the influence of whatever they’ve ingested that day and nothing at all to do with their mind state.