FDA approves Vraylar / Cariprazine to treat schizophrenia and bipolar disorder

I bet that erection side effect was a side effect discovered AFTER the drug was put on the market. This drug hasn’t even been put on the market yet. That is the distinction. As @everhopeful says, ITI-007 has the promise to be even better than a CBD based antipsychotic, because not only does it have a extremely low side effect profile based on phase 2 trial, it is also proven to be very effective at treating both positive, and especially negative, symptoms, so I am more excited about ITI-007 than this one.

Your betting is just more speculation. Again, for someone so keen on the facts of this new drug you’re throwing around an awful lot of speculative input out there - The stats show what any stats will show in trial of a new medication. Numbers, percentages, risks - All at an accurate level due to the legality of things.

Irrespective of when the side effect was suffered the drug has been approved for market, you don’t have to use it - To have such a strong anti-stance of it without doing your research doesn’t say anything about the drug, just your willingness to be put off by guess work.

Personally, I want to try this because ANY chance at lessening my symptoms is welcomed. Waiting for a miracle cure is fine but some of us need as much help as we can get. Progress is a slow process with these things.

Just seen your edited response, sounds much more reasonable when you word it that way - Came off like an unwillingness to try anything because you were convinced it wasn’t worth looking into.

Either way I hope you find the help you need in whatever form of medication you put your faith in.

This won’t be licensed in Europe until 2018, had it confirmed. Ah, well…

Where did you read that @HarveySpecter ? :frowning:

I agree - no medication or supplement is likely to be a miracle cure. Set your expectations correctly - this may be helpful to some people, likely not all people.

Its interesting - and worth looking at, and please, people who try it be sure to report back here on the pros and cons of the medication.

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Things that are too good to be true, usually are. Don’t buy into the hype. Every medication comes out with just hype from the companies promoting them - then the reality is always less than we hope.

This has been true for every medication that has come out over the past 20 years - from Risperdal to Abilify… so don’t get caught up in the hype as you’ll only be disappointed.

They are interesting, and worth a look at - but nothing more at this point. Lets wait for real life data from our users here before drawing any conclusions.

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Everything sucks.

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Not completely - I’d say “Almost everything sucks at least a little bit”, and “Almost everything is great, for some people, some of the time”

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as the sheep fall in line to become Ginnie pigs…

It takes on average three years for a European license on U.S approved medicines - My psychiatrist confirmed with her pharmaceutical team :frowning:

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That’s something I really didn’t want to hear.

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Sorry to be the bearer of bad news, I assume the same will apply for the ITI-007 as well. Sucks to be European right now.

Then again:

http://www.raps.org/focus-online/news/news-article-view/article/1798/

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I believe that’s in regard to drugs submitted as new medicines, and not as a follow on from drugs already approved for marketing elsewhere - The drug was submitted to the FDA only and not any other bodies, so the licensing over here will be around the three year mark as expected - Same will apply with ITI-007 I’m afraid

I’m just concerned about iti-007 at this point. And maybe gw pharma’s cbd meds. It would suck so bad if iti-007 lived up to the hype and I had to wait till 2020 or something.

On the plus side, it stops me from being a guinea pig I guess. But that’s cold comfort.

Rexulti has just been approved in the US, so that will be a good test to see how long European approval takes nowadays.

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I’m quite worried about iti-007 not doing better than placebo. The good thing is it is considered third generation as it works on glutamate and is an entirely new molecule.

It did no better than placebo at 120mg, but did just as well as risperidone at 60mg if I remember correctly.

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The more you read - the more this drug seems likely to be underwhelming…

“The agency rejected cariprazine in 2013 and demanded more clinical trial data to determine the ideal dose of the drug, its inventors said at the time. Two years later, Allergan and Gedeon completed a follow-up Phase III trial in which cariprazine met its goals of reducing schizophrenic relapses compared with placebo, adding those results to combined data from more than 2,700 schizophrenia and bipolar patients in their successful resubmission.”

Cariprazine, to be sold as Vraylar, was once considered a potential blockbuster, with Richter setting its sales potential at as much as $2 billion a year. But the drug’s long path to market has dampened enthusiasm among analysts, and Evercore-ISI’s Umer Raffat pegs its peak value closer to $200 million a year.

The drug is a potent dopamine D3/D2 receptor partial agonist atypical antipsychotic…

Nothing really new here - Abilify is in the same class of medications…

and

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