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!!! Iā€™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 companiesā€¦keep shoving dangerous drugs down our throats please FDAā€¦dont approve CBD meds oh no that might be good for youā€¦

I wouldnā€™t jump straight for it, I bet money it isnā€™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 cureā€¦ 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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Iā€™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, youā€™re not gonna suffer them all or even many.

Itā€™s by no means a shining light in eradicating Bipolar and/or Schizophrenia but it seems an improvement on the current options, itā€™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 Iā€™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, doesnā€™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. Iā€™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 donā€™t understand the level of scepticism without actively looking at the statistics involved. Itā€™s not my job to do your research for you, Iā€™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, Iā€™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 hoursā€™ - The art of the law of averages is that SOME people will fall victim to certain side effects that others donā€™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€˜factsā€™ā€™ 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. Letā€™s just assume everyone who CHOOSES to take their own life has done so due to the influence of whatever theyā€™ve ingested that day and nothing at all to do with their mind state.