Cannabidiol Oral Solution Fast Tracked for Rare Pediatric Disorder
Insys Therapeutics announced that the Food and Drug Administration (FDA) has granted Fast Track designation for cannabidiol oral solution to treat Prader-Willi syndrome.
This rare genetic disorder is characterized by an insatiable appetite in children that can cause life-threatening obesity and type 2 diabetes. There is currently no approved treatment for Prader-Willi syndrome.
The Company plans to initiate a clinical development program in the late first quarter of 2018. The Phase 2 study's primary objectives will be to assess the efficacy of cannabidiol oral solution on hyperphagia-related behavior in patients with Prader-Willi syndrome, and to assess its efficacy on body weight in patients with Prader-Willi syndrome.
Cannabidiol oral solution is also under investigation for childhood absence epilepsy and infantile spasms.
For more information call (602) 910-2617 or visit InsysRx.com.