3 ms·
https://www.sciencedirect.com/science/article/pii/S0140673623021906?casa_token=1c8ciudcSp8AAAAA:5ICP1F9fDsBqG-AaO6nxyfohx-6_BmzlHxLTwrkTXgXHWonOOlRLWRR1fP8buzng
by ndynan 2y ago
https://www.sciencedirect.com/science/article/pii/S0140673623021906?casa_token=1c8ciudcSp8AAAAA:5ICP1F9fDsBqG-AaO6nxyfohx-6_BmzlHxLTwrkTXgXHWonOOlRLWRR1fP8buzngJZOXbpOy 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.
- throwup238 2y agoFrom 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-Presents-New-Pooled-Interim-Long-Term-Safety-and-Metabolic-Outcomes-Data-from-the-EMERGENT-Program-Evaluating-KarXT-in-Schizophrenia-at-the-2024-Annual-Congress-of-the-Schizophrenia-International-Research-Society/default.aspx https://news.bms.com/news/details/2024/Bristol-Myers-Squibb-...
- ndynan 2y agoThanks 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.