Insys' Cannabidiol Gets Orphan Drug Designation For Pediatric Schizophrenia

(RTTNews) - Insys Therapeutics, Inc. (INSY), a specialty pharmaceutical company, Monday said that the U.S. Food and Drug Administration has designated its drug candidate Cannabidiol as an Orphan Drug to treat Pediatric Schizophrenia.

Pediatric schizophrenia is a severe brain disorder that causes a child to interpret reality abnormally and has a profound impact on a child's behavior and development. The designation allows the company to enjoy seven years of U.S. marketing exclusivity for the drug upon approval, along with other additional incentives.

The company expects to conduct the phase 1 clinical trial to test the drug in humans, in early 2015.

Cannabidiol has previously received Orphan Drug designations, to treat glioma, glioblastoma multiforme, and two rare forms of pediatric epilepsy, Lennox-Gastaut Syndrome and Dravet Syndrome.

Insys is evaluating the potential use of Cannabidiol to treat adult epilepsy, chemotherapy-induced peripheral neuropathy, and addiction in cocaine, amphetamines and opioids, the company said.