Posted by Michael Wonder on 27 Dec 2017
FDA grants Insys Therapeutics ‘fast track’ designation for cannabidiol oral solution as investigational treatment for Prader-Willi syndrome
26 December 2017 - INSYS Therapeutics announced today that the U.S. FDA has granted fast track designation to the company’s cannabidiol oral solution for the treatment of Prader-Willi syndrome, a rare and complex genetic disorder characterised by insatiable appetite in children that often leads to obesity and type 2 diabetes.
“FDA’s Fast Track designation will enable an expedited regulatory review process for our proprietary formulation of CBD in the treatment of pediatric patients with Prader-Willi syndrome, a debilitating condition which currently does not have any approved products available,” said Steve Sherman, senior vice president of regulatory affairs for INSYS Therapeutics. “We plan to start the clinical development program for this promising therapy in late first quarter of 2018.”
