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by ndynan 632 days ago
https://www.sciencedirect.com/science/article/pii/S014067362...

Here is the drug trial results for EMERGENT-2 which was one of the two phase-3 trials that lead to the approval.

I think its striking that the trial is only 5-weeks long and this medication gets approval.

1 comments

From your linked paper:

> Results from additional trials, including the identical EMERGENT-3 trial and the 52-week, open-label EMERGENT-4 and EMERGENT-5 trials, will provide additional information on the efficacy and safety of KarXT in people with schizophrenia.

EMERGENT-4 and EMERGENT-5 concluded last year [1], which was the reason for the approval. EMERGENT-2 was mostly a milestone Karuna Therapeutics used to get enough funding for the rest of the trials and inform their design.

[1] https://news.bms.com/news/details/2024/Bristol-Myers-Squibb-...

Thanks for the info - curious to look at these trials and see if there are sustained long term positive outcomes on the PANSS or these are just safety /tolerability studies.