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Insys Therapeutics Receives FDA Orphan Drug Designation for Its Pharmaceutical Cannabidiol as a Potential Treatment for Dravet Syndrome, a Rare Form of Epilepsy

2/07/2014 by


Insys Therapeutics, Inc., a specialty pharmaceutical company that is developing and commercialising innovative drugs and novel drug delivery systems, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its pharmaceutical cannabidiol (CBD) for the treatment of Dravet syndrome, a rare pediatric-onset epilepsy.

“There is presently no cure for this catastrophic form of epilepsy, and the significant, unmet need is recognised by the orphan drug designation we received today for our pharmaceutical CBD,” said Michael L. Babich, President and Chief Executive Officer. “Our pharmaceutical CBD is an alternative to plant derived cannabinoids, one which we believe will provide significant medical benefits and better address the unmet needs of patients across multiple indications including Dravet syndrome. We expect to file an Investigational New Drug Application (IND) for CBD in the second half of 2014.”

Insys has more than seven years of research and development experience in the pharmaceutical cannabinoid space. The company manufactures pharmaceutical dronabinol (THC) and pharmaceutical CBD, both of which are cannabinoids, at its FDA-inspected and Drug Enforcement Administration (DEA) approved facility in Round Rock, Texas. Insys believes it is the only U.S.-based company with the capacity to produce pharmaceutical cannabinoids in scalable quantities.

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