‘‘Through this transaction, BMS has added KarXT (xanomeline-trospium), an antipsychotic with a novel mechanism of action and a differentiated efficacy and safety profile, and Karuna’s early-stage and pre-clinical pipeline. KarXT has a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024 for the treatment of schizophrenia in adults. KarXT is also in registrational trials both for adjunctive therapy to existing standard of care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease, with potential to expand to additional indications, including Bipolar I disorder and Alzheimer’s disease agitation.’’
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Seems like officially, the drug is still considered promising. Hopefully it does well by patients
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First it will be in the United States, then in Europe, and then in the rest of the world. We will have to wait.
It is definitely better than current antipsychotics.
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Not necessarily.
The reduction in the PANNS implies that it reduces both the positives and the negatives, so the total reduction is the aggregate for the positive and the negatives. If it reduces negatives even marginally in terms of the PANNS, then it may be much less effective for the positives than we think currently. What do you think?
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There is also the SANS scale. On that scale, KarXT scored twice as high as the placebo. But I think the score was modest.
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So, suppose it reduced 10 points from the PANNS and it reduced 4 from the SANS, then it is something like a 6 reduction for the positive symptoms. Then, this 6 needs to be compared with current other APs.
The mistake we are making when we considering it to be more effective than Olanzapine for positives is that we are assuming the aggregate reduction for both the positives and the negatives to apply to the positives. But, if it effective for the negatives, it may be a relatively weak medication for the positives. Conversely, if it is not that effective for the negatives, and say an Olanzapine for the positives, then it is only better because of its side effect profile. Then, the question is, is it the medication that we are expecting it to be?
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I don’t think it is the ideal medication. Ulotaront I’m sure it does, but unfortunately it failed in phase 3, but according to what they say it is still in testing.
But I think that schizophrenia is different in each person, surely karxt will be much more tolerable in some people than in others. The same thing happens with current antipsychotics.
The positive thing I see is that we will have more options when it comes to treating the disease. Especially if Ulotaront, which has fast track designation by the FDA, is approved. If approved it would be in 1 or 2 years.
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Yeah, overall seems like a really good medication with its side effect profile.
I was just cautioning you to not over-rely on the medication to treat all the symptoms, as it may not be as effective for positive symptoms as we are thinking (like better than Olanzapine).
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Yes, I understand what you are saying. It is never good to get so excited about a medication until you have tried it.
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In the Emergent 3 trial, total PANSS reduction was 20.6 for KarXT, 12.2 for placebo. As per patient from Japan on Matsblog.
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So, it was 8.4 more than placebo. Out of this 8.4 how much was the positive subscale effect and how much was the negative subscale effect remains to be seen, I believe. So, depending upon the situation, it could be a very weak medication for positive symptoms, and good for negative symptoms. Or, it may be strong for positive symptoms, and very weak for negative symptoms. Or, it could be reasonably strong for both. Who knows?
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On the negative subscale. KarXT scored 3.2 versus 1.8 for placebo.
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