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. 

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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. 

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