Statin intolerance = 20 percent of patients conservatively. Some place this percentage at 25 %.
Just hang in there.
John Kane, MD UCSF knows what he is talking about.
Got it: Based on the preclinical and clinical results described above the Company selected doses of 60 mg and 40 mg of ITI-007 for the ongoing Phase 3 clinical trial in schizophrenia. This study, ITI-007-301, is a randomized, double-blind, placebo-controlled, inpatient clinical trial in patients with an acutely exacerbated episode of schizophrenia. In this trial, over 400 patients are expected to be randomized to receive one of three treatments: 60 mg ITI-007, 40 mg ITI-007 or placebo in a 1:1:1 ratio. The Company anticipates topline results from this trial will be available in the second half of 2015.
This is a good move on their part. The FDA may or may not consider the phase 2 data for 120 mg; most likely not, if phase 3 does not include that dosing. Can you tell me in what Aug research report you found the data.
I am growing more concerned about the the lack of efficacy at 120. The FDA does not favor meds with an inverted u shaped curve. THe inverted u shaped curve may be result of stimulation of pre-synaptic and blockade of post-synaptic DA receptors. But the FDA may not buy that. The authors ofthe paper stated that the inverted U-shaped curve might have been secondary to sedation, but I'm not buying that. This may be true for animal studies, but not humans. l fear that the FDA may decide that ITI-007 carries a limited efficacy. That would be trouble. I'm cutting my shares.
Yes, slightly off thread - but here is a quote from article:
ITI-007 60 mg demonstrated a statistically and clinically significant reduction in schizophrenia symptoms in comparison to placebo, meeting the primary endpoint of this trial. Its therapeutic effect on total PANSS was comparable to risperidone, a widely used APD, with an ES of 0.4 in
the range of other effective antipsychotics tested in four week treatment trials (21). In addition, individuals treated with 60 mg ITI-007 exhibited improvement across a broad range of symptoms, beyond psychosis including general psychopathology, negative and depressive
symptoms, the latter two of which are believed to be associated with social function.
The authors note that larger studies are needed to verify and support the initial findings regarding negative sxs and ITI-007 impact upon mood. However, this is a frequently encountered comment for phase 2 trials as the n is so low.
The PANSS score was the same as Risperidone as far as I can see. In addition, patients with negative sxs and depression were helped in a way that suggests ITI-007 is different from that agent.