US FDA flags four deaths in Newron's schizophrenia drug studies (Evenamide)

https://www.reuters.com/legal/litigation/us-fda-cites-4-deaths-newrons-schizophrenia-drug-trial-hold-2026-10-08/

“Italy’s Newron Pharmaceuticals, said on Thursday the US FDA had identified four deaths among patients treated with its experimental ​schizophrenia drug in feedback following the agency’s earlier decision ‌to place a clinical hold on the treatment’s trial in the US.”

After reading this, I unfortunately think it’s very likely that evenamide won’t move forward into the market.

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I wonder what it did to them that caused death. Pretty scary

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I agree. Besides, neither the FDA nor the lab said what they died of. It’s quite scary.

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Rest in peace :dove:

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Many antipsychotics have severe side effects that are rare or extremely rare. Mine says sudden death as a very rare one

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It seems these aren’t the only deaths. The lab also reported one death in the previous phase trial. I think it’s unlikely to come to market.

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That’s very scary.

It probably won’t come out to market

I agree

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Sounds unfortunate, I was expecting good results from the test and had pretty high hopes for the drug. But maybe it is for the best they found out this sooner rather than later. Maybe it will be sorted out in due time. Thankfully there are othrr drugs in the pipeline in any case. Not the best way to find out drug has problems, that is certain.

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Nothing to see

It says in this article it was fatal arrhythmias https://firstwordpharma.com/story/8190596

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@kali Yes, there are several drugs in development. But they’re in early stages. The most advanced was Evenamide. That’s a shame.

@Lilyofthevalley So Evenamide can cause fatal heart attacks. Terrible!

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I don’t get it. Olanzapine has sudden death listed as a side effect. Why drag hockey into it? :ice_hockey:

@TheCanuk

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Seriously? Now im worried.

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Bring it on!!!

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I think all AP’s have this as a rare side effect.

I wouldn’t worry though. It’s less than 1 in 100.

I think they mostly list it to avoid lawsuits.

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There’s gotta be a way to predict who’s at risk and who’s not. This drug has too much potential to just completely shelf. The sad part is we’re so close. They could be prescribing this drug in 2028. I don’t know how much longer any of this is going to matter though, i think we’re only a handful of years away from something like personalized medicine.

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Hi, i read that people with underlying heart conditions are most at risk. But not everyone who has a heart condition knows they have it. Thats why regular health checks are important. Like ecg, bloods while taking antipsychotics

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they just need to identify what’s causing the cardiac issues and screen out whoever’s vulnerable. For certain people evenamide’s been a miracle. It’s also probably important to identify whether it’s actually causing the damage or just pushing people past a threshold. The tragic irony being the underlying issues were most likely caused by years of being on other antipsychotics.

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There’s truth to that. I got cardiac issues on the minimum dosage of seroquel and latuda which I tried after 15 years on zyprexa. So I have to remain on zyprexa. I don’t think that’s normal at all.

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