Insys Therapeutics, Inc. (
), 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.