Insys 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.
Insys Therapeutics to initiate five Phase III trials in FY15 Insys Therapeutics announced progress and expected milestones for multiple projects in its pipeline of innovative supportive care and therapy products and candidates. The company intends to submit a New Drug Application to the FDA and to advance five programs into Phase III clinical trials in 2015.