http://ir.intracellulartherapies.com/releasedetail.cfm?ReleaseID=1023676
We are preparing responses to the FDA’s request for additional information and intend to proceed with our long-term safety study of lumateperone in patients with schizophrenia. If the FDA deems our responses regarding the nonclinical findings to be sufficient, we intend to submit an NDA for lumateperone for the treatment of schizophrenia by mid-year 2018 supported by the efficacy studies we have conducted to date. If the FDA deems our responses insufficient, they may place our long-term safety study on a clinical hold. The results of the long-term safety study will be required to support an NDA approval for a chronic condition such as schizophrenia.
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Geez @jamesbond , you’re quick off the mark. That news is hot off the press! Thanks.
We are preparing responses to the FDA’s request for additional information and intend to proceed with our long-term safety study of lumateperone in patients with schizophrenia. If the FDA deems our responses regarding the nonclinical findings to be sufficient, we intend to submit an NDA for lumateperone for the treatment of schizophrenia by mid-year 2018 supported by the efficacy studies we have conducted to date. If the FDA deems our responses insufficient, they may place our long-term safety study on a clinical hold. The results of the long-term safety study will be required to support an NDA approval for a chronic condition such as schizophrenia.
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So if it works (which it probably doesn’t). It might be out by 2019. That sounds a bit iffy and a long time to wait.
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love to see it coming to market…i wish it could pass phase 3rd …!!! finger crossed ,!!!
So now they also have to prove long term safety.
The stock price is down 37% right now today.
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What do they mean by “long term” ? Are we talking 1 year, 2, 5… ?
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haha james bond and 007 haha what a co incidence …!!!
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"The results of the long-term safety study will be required to support an NDA approval for a chronic condition such as schizophrenia. "
If the company is considering possible NDA in mid 2018, then the long term safety study might not be very long.
Yes! There is a chance. Hopefully the FDA allows this to go to market.
Still they need to test it at 80 or 100mg, they shouldn’t have jumped to 120.
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NDA review process takes like a year, if approved we can expect the drug to be marketed in up to a year.
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It has to pass in its final hurdle …
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Well, mixed news. Isn’t there an open extension phase after a clinical trial where participants can continue on the drug? They also mention the possibility of the FDA placing a clinical hold on the safety study if they are not satisfied with the company response. They stated that in the animal tests the drug was metabolized differently. So hard to tell from the response, but it sounds like the long term safety study may be already in progress.
There will probably be press from writers that listened to the call and webcast.
Yeah but they said they would submit the NDA in 2018, so maybe a year after that. Assuming all goes well, of course.
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https://www.thestreet.com/story/14111583/1/intra-cellular-evades-scrutiny-on-schizophrenia-drug-safety-shares-plunge.html
Just to add to this:
Intra-Cellular Therapies (ITCI) was already on shaky ground with investors over the future of its schizophrenia drug, so management’s refusal to answer obvious questions about a new safety concern was a self-inflicted wound that sent the stock plunging to an all-time low.
On Monday, Intra-Cellular reported on a meeting held with FDA in which regulators raised questions about toxicity observed in animals treated with its schizophrenia drug lumateperone (also known as ITI-007.) The FDA wants Intra-Cellular to provide more information about the animal toxicity before moving forward with an approval filing, the company said.
Intra-Cellular 's willingness to be transparent about the new safety issue basically ended there. On a conference call, company executives, include CEO Sharon Mates, said the lumateperone toxicity was seen in dogs treated at much higher dose levels than what’s used in people. Dogs also metabolize, or break down, lumateperone differently than people, which led the company to believe the toxicity was not going to be a problem for FDA.
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There’s just no way this drug is going to make it to the market with all this bad press. Looks like we’re stuck with ■■■■■■■■ like Vraylar and Rexulti for the next decade
The question isn’t really the press, it’s is it safe and does it work. I guess the FDA has at least for now accepted the phase 2 and the first phase 3 for efficacy. The safety concerns are serious, however, we just have to wait and see. It is true that dogs and humans do not metabolize drugs the same way. I mean, you can’t feed dogs grapes, chocolate or onions, it’s not good for them; humans, no problem. I haven’t seen that these issues were public before though, and that lack of transparency is troubling. It doesn’t necessarily mean the drug is safe or unsafe. We’ll just have to wait for the study.
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I’m also most troubled by the lack of transparency.
You can read the update either negatively or positively. I think the only obstacles now are the long term safety trial and the nda review process. After those the drug has made it. Nothing has shown this to be unsafe in humans, in the short term its safety was similar to placebo. We’re almost in.
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