Karuna Therapeutics Reports the NDA Submission of KarXT to the US FDA for the Treatment of Schizophrenia
Shots:
- The company has submitted the NDA to the US FDA for KarXT (a dual M1/M4 muscarinic agonist) to treat schizophrenia. The submission was based on the (EMERGENT) program i.e., (EMERGENT-1/2/3) trials evaluating KarXT vs PBO and the ongoing (EMERGENT-4 & 5) trials of KarXT
- In all three PBO-controlled trials, KarXT met its 1EPs & showed a reduction in PANSS total score, reductions in both positive and negative symptoms of schizophrenia as measured by PANSS+, PANSS-, and PANSS negative Marder factor subscales were reported
- The therapy was well-tolerated & the discontinuation rates due to TEAEs were low and similar b/w KarXT & PBO across all trials
Ref: Businesswire | Image: Karuna Therapeutics
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