Karxt PANSS out again for Karuna; NDA slated for midyear

With phase III data in hand from the Emergent-3 study of Karxt (xanomeline plus trospium) in adults with schizophrenia, Karuna Therapeutics Inc. continues to target mid-2023 for an NDA submission to the U.S. FDA. The 256-subject trial met its primary endpoint, with Karxt turning up a statistically significant and clinically meaningful 8.4-point reduction in Positive and Negative Syndrome Scale total score compared to placebo at the fifth week.

7 Likes

Damn Finally Something Coming To Help …

1 Like

According to the Japanese patient-guru, the effect size was .60 in the Emergent-3 trial. This is slightly better than Resperidal or Zyprexa. The Emergent-1 trial had an effect size of .75. Emergent-2 had an effect size of .61. The placebo effect varies and is part of the difference.

3 Likes

But I heard KarXT doesn’t do much for negatives.

2 Likes

If its mechanism does not involve affecting the dopaminergic system, it could substantially improve the negative symptoms in some people. It depends on each person. In my case it would be fantastic because conventional antipsychotics, by decreasing dopamine, transform me into a zombie.
However, there are people who take conventional antipsychotics and don’t have that side effect.

4 Likes

They always hype these drugs up, saying no side effects etc., but when they come out everyone hates them.

2 Likes

It doesn’t improve negative symptoms, but does it improve cognitive symptoms?

2 Likes

Every person is a world. Perhaps karxt will be much better for me than the conventional ones and by taking it I will begin to lose all the weight gained with conventional antipsychotics. The reality is that only those who were in the trials of this drug know if it is good or not.

1 Like

I think it’s only for positive and negative symptoms.

“All tradesmen cry up their own wares;
In this they agree well together:
The Mason by stone and lime swears;
The Tanner is always for leather.
The Smith still for iron would go;
The Schoolmaster stands up for teaching;
And the Parson would have you to know,
There’s nothing on earth like his preaching.”

(Lord Neaves)

1 Like

But in this case, they mentioned that there are side effects though lol

2 Likes

I remember waiting for invega to be released in hospital. I couldn’t wait for it. The doctor said it should be better because it’s new.

I waited while suffering on one antipsychotic, I couldn’t wait for invega, thinking it would help. The sad story is it ■■■■■■ me up.

So I learned not to get my hopes up.

3 Likes

Each person is different, for example in my case, I have taken haldol, abilify, risperidone, and olanzapine. And with all of them I had the same terrible side effects… indefinite weight gain, extreme sedation, suicidal thoughts.
However, there are people who taking these medications do not have any of this.
I suppose it’s because my diagnosis is more like mild psychosis than schizophrenia, and that’s the point. That antipsychotic drugs with another mechanism exist in the future so that it is at least “tolerable” for those of us who do not have schizophrenia but something “different.”

3 Likes

@Nirvana

Actually, I agree with you. Some people have no side effects, and others do.

2 Likes

I hope for future cellular-level studies of genetical/epigenetical changes and interactions, in order to separate the currently used diagnoses into something palpably associated with specific gene defects and signaling pathways.

And recently there was a news on a new technique allowing for targeted short-term opening of the blood-brain barrier in chosen parts of the brain, to let medication in, used for cancer treatment. Maybe in the future some neural growth factors could be delivered precisely to the hippocampus or the cortex of patients, to increase the number of connections and improve neural network function.

2 Likes

Your comment is very interesting. It makes me very happy to know that technology does not stop advancing in the field of medicine. And there is also the method of stem cells, right? but for that it takes more time I think.

1 Like

I want to see the chart of the reduction of the negative PANNS: Does it become more flat after some weeks or does it go down steeply (like it did in the phase 2 trial!)? Furthermore, which subitems of the negative PANSS showed a reduction? Difficulty in abstract thinking or avolition?

In summary, I want to see the article about the phase 3 trial, not only a news message.

But I’m still very confident!

2 Likes

The article is about top line results. The detailed bottom line results will not be published for months.

2 Likes