I was searching the web and found that iti007 failed a second phase 3 trial.I’m so dissappointed. Does this mean that it won’t be coming out.
metal illness is complex …!! iti 007 has low side effect profile.!!! but it has failed …not too sure …it may come out …!!!
We have known this since late 2016. The FDA will accept an nda if iti provides some long term safety info from an all new trial. If the fda reviews all the info and thinks the drug is ok it might be on the market around summer 2019.
It had good results in a phase 2 trial and in one phase 3 trial. In the second phase 3 trial, the drug performed similarly to past trials, but the placebo response for some reason about doubled and was better than ITI 007. Also the active control, risperdal, performed better in this test.
The FDA said the 2nd phase 3 trial results do not preclude them submitting an NDA, (new drug application) but there are some safety concerns with the drug in animal studies (dogs) which the company says they can prove to the FDA won’t apply to humans, has to do with how dogs and humans metabolize it differently. But they are not being very transparent about it with the public. So the FDA wants a long term safety study, the comapny plans to submit an NDA in a year (mid 2018) which is also around the time that some other studies on bipolar will be ending. So they may have some additional efficacy data to support their application at that time.
I can’t say whether it will be approved or not but it may. Going to be a few more years.