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May 6, 2014
07:21 EDTINSYInsys Therapeutics to advance development of CBD to treat epilepsy
Insys Therapeutics announced plans to advance development of its pharmaceutical Cannabidiol, or CBD, a synthetically produced and over 99% pure form of cannabidiol, to treat epilepsy in children and adults. Insys has engaged a large international Clinical Research Organization to provide development and regulatory services and has hired Mark Davis as Senior Clinical Director to oversee this program. Insys plans to file an Investigational New Drug application with the FDA in the second half of 2014 for CBD for the treatment of epilepsy. In pediatrics, Insys plans to pursue development of treatments for Lennox-Gastaut Syndrome and Dravet Syndrome, which are orphan indications.
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November 24, 2014
07:04 EDTINSYInsys Therapeutics receives FDA orphan drug designation to CBD candidate
Insys Therapeutics announced that the FDA has granted orphan drug designation, or ODD, to its pharmaceutical cannabidiol, or CBD, candidate for the treatment of pediatric schizophrenia. This marks the fifth ODD for the company's CBD program.
November 19, 2014
12:04 EDTINSYInsys Therapeutics cannabidiol receives FDA orphan designation
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