...product to US FDA by Q2 2008..
I can't get the article to open...anyone know anything about this???
Is it fluoxetine? Another SSRI...
Stephen
Yes, NPL-2008 is fluoxetine. Looks like they are going to do a study in collaboration with Autism Speaks CTN (clinical trials network) with patient enrollment happening this year (2007).
The SOFIA trial, which is seeking to show a reduction in the core symptomatology
of autism, is a randomised, double-blind, placebo-controlled trial comprising
more than 100 children and adolescents in approximately 12 centres throughout
the US, where NPL-2008 has Orphan Drug Designation. It is expected that the
first patients will be enrolled in Q3 2007 into the trial, which follows
positive results from an earlier single-centre Phase III study funded by a grant
from the US Food and Drug Administration's Office of Orphan Product Development.
Assuming the trial goes well and there is an FDA submission in 2008, approval and product launch in the US would not be until late 2009 (unless of course they get fast track status).