Allergan, Richter Stay Committed to Cariprazine Despite Phase III Failure

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Allergan and Gedeon Richter said they will continue to develop the marketed bipolar I disorder and schizophrenia drug cariprazine despite the failure of the drug in a Phase III trial for a new indication.

Cariprazine missed its primary endpoint in the MD-72 trial of showing significant improvement as an adjunctive treatment to antidepressant therapy in adults with major depressive disorder (MDD) who failed to respond adequately to antidepressant monotherapy, the companies acknowledged.

MD-72 was a prospective, randomized, double-blind, placebo-controlled, parallel-group study evaluating flexible doses of cariprazine (1.5–4.5 mg) conducted at numerous U.S. sites.

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Why Sz drugs fail in so much need…!!!

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It’s just not up to scratch to deal with the depressive side of things.

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What does this nean? Its not good for neg. simpotms then? Or only for mdd?

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The research so far indicates it’s not good for MDD. According to http://www.fiercebiotech.com/biotech/allergan-and-richter-push-ahead-despite-phiii-fail-for-depression-drug

Allergan and Richter are also assessing the efficacy of cariprazine in bipolar depression and predominant negative symptoms of schizophrenia.

I guess we’ll see outcome results for predominant negative symptoms fairly soon.

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We will soon see then if vraylar is good for neg. symptoms. I really need a med for strong negative symptoms really fast. Another question. It’s been sold on western europe or not yet firemonkey? Thanks

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As far as I know it’s not being sold in Western Europe yet but will be soon.

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Hm that’s very cool im from portugal so i think it will be avaiable here too. Thanks firemonkey.

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I don’t know, although Cariprazine was way to stimulating for me, I felt that it had strong mood elevating - antidepressant properties.

I am surprised by these results.

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The original study stated:

`> From a baseline PANSS-NFS of approximately 27 in both treatment arms, the change from baseline at week 26 was significantly greater, at -8.9, in the cariprazine group compared with -7.4 for the risperidone control group (P = .002).

Thats only a 1-2 point difference. Cariprazine only has a minor impact on negative symptoms and this was a single study. Don’t get too excited when you hear them talking about negative symptoms.`

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No I am sure that it was proven to help with Negative Symptoms.
When I was taking Vraylar (Cariprazine)
My Avolition and Anhedonia symptoms were significantly improved.

I was more motivated and actually felt more pleasure- listening to music Etc…

Just because it is failing as a MDD medication, does not mean that it can’t help those people suffering from Negative Symptoms.

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