Why haven’t these guys released a report on what will happen with Lumateperone, whether or not they are going to send in a new drug applications or what they are going to do. They said they would get the message out at the end of March. It has been over a week. Are they going to do another phase 3 trial? Speculation as to what is going to happen and when they are going to report it is welcome on this thread.
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My guess is they will continue testing for bipolar disorder which means another round of phase three trials before it gets to the market. Schizophrenia ITi is kaput!
IT is in phase 1 or 2 for bipolar, meaning it is a long way away.
That’s just my guess. Unless they pay to have it approved, which is not unheard of
They can do that? Pay the fda directly to overlook a failed trial? If they do they will need to make a lotta money off subsequent sales of the drug to make up for it.
They have their ways. If a drug doesn’t make it the first time and they sunk a ton of money and time into it then I think they push it through
Its in phase 3 for bipolar depression.
So Intracellular has 2 trials for bipolar recruiting on clinicaltrials.gov. They are both phase 3. There were no phase 2 trials listed, so I don’t know if they were able to go directly to phase 3 due to the phase 2 trials in sz. I guess so, that’s all I can think of. Purely speculation, but I think the company is deciding if they want to proceed with the trials, cancel them, or possibly alter the study parameters given what they know from the phase 3 in sz.
Another possibility I think (again, pure speculation) is if they don’t have the resources to continue pursuing the drug is that they may sell it or license it for development to another company.
I doubt the FDA takes bribes, or Intracellular offer them, because if the drug isn’t proven to work better than placebo, and someone took it, had a psychotic break and killed themselves or someone else, the lawyers would be lining up. I know people have psychotic episodes on approved drugs all the time, but all those drugs still are proven thru the current drug testing system as better than placebo.
No thank you I’ll be sticking to Risperidone.
At least it has a proven track record.
Side effects and all.
What phase is pimavanserin in for schizophrenia? Lumateperone and min-101, are both 5ht2a antagonists. Pimavanserin is a 5ht2a inverse agonist and antagonist. So it is kind of similar. Pimavanserin might be approved soon as an adjunct to existing antipsychotics.
Pimavanserin is approved for Parkinsons. It’s in phase 3 for schizophrenia. I believe they are currently recruiting. It is also in trials for MDD and Alzheimers.
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