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FDA approves Vraylar - 97 week phase III study

Posted by SLS on September 20, 2015, at 5:53:37

In reply to Re: FDA approves Vraylar for schizophrenia, bipolar, posted by Lamdage22 on September 20, 2015, at 4:14:19

> there are no anecdotes whatsoever about cariprazine

None that have been made readily available, anyway.

Cariprazine acts like Abilify as a dopamine receptor partial agonist. However, it hits D3 receptors harder than D2 receptors when compared to Abilify. It is more selective for D3, and might have more antidepressant effects than Abilify. That is my hope, anyway. I don't know if there are any other advantages to cariprazine. It probably will cause weight gain and some degree of startup akathisia. I hope to find out soon.

Open label protocol:

http://www.prnewswire.com/news-releases/richter-and-actavis-announce-positive-phase-iii-results-for-cariprazine-in-the-prevention-of-relapse-in-patients-with-schizophrenia-300022547.html

"About this Phase III Study
This 97 week study was a multi-national, multi-center, randomized, double-blind, placebo-controlled clinical trial in adult patients with schizophrenia. The study included a 20-week open-label phase where patients with schizophrenia were treated with cariprazine 3, 6 or 9 mg per day. Patients who responded and met the stabilization criteria during the open-label period were then randomized to continue their cariprazine dose (3, 6 or 9 mg per day) or switched to placebo for up to 72 weeks or until a relapse occurred. The primary endpoint was time to first symptom relapse during the double blind phase.

In the double-blind phase, there were no cariprazine adverse events >/=10%. Across the cariprazine treated group, the most common adverse events (incidence >/=5% and greater than placebo) were nasopharyngitis, tremor, extrapyramidal disorder, akathisia, back pain, and blood creatine phosphokinase increased."


- Scott


Some see things as they are and ask why.
I dream of things that never were and ask why not.

- George Bernard Shaw

 

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