Insys Therapeutics’ Cannabidiol Receives FDA Orphan Drug Designation – Drug Discovery & Development

Insys Therapeutics, Inc., a specialty pharmaceutical company that is developing and commercializing innovative drugs and novel drug delivery systems, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its pharmaceutical cannabidiol (CBD) for the treatment of glioma, which comprises approximately 80% of all malignant brain tumors. The ODD includes pontine glioma (PG), a devastating form of primary brainstem glioma.

“We are pleased to have received broad orphan drug designation for CBD to treat glioma,” said Michael Babich, president and chief executive officer. “We will most likely focus initially on pontine glioma, or PG, which has multiple similarities with glioblastoma multiforme, for which our pharmaceutical CBD was granted ODD last month. We believe that this product has excellent potential as treatment for PG, and look forward to advancing its development and offering a potential efficacious treatment for patients.”

Insys, which has more than seven years of research and development experience in the pharmaceutical cannabinoid space, manufactures pharmaceutical CBD and pharmaceutical dronabinol (THC), both of which are cannabinoids, at its FDA-inspected and Drug Enforcement Administration (DEA) approved facility in Round Rock, Texas. The company recently submitted a Drug Master File (DMF #28255) for its CBD active pharmaceutical ingredient and believes that it is the only U.S.-based company with the capacity to produce pharmaceutical cannabinoids in scalable quantities.

Insys was previously granted ODD to its pharmaceutical CBD for the treatment of glioblastoma multiforme (GBM), the most common and most aggressive malignant primary brain tumor in humans, and two rare forms of epilepsy, Lennox-Gastaut Syndrome and Dravet Syndrome. Insys is also evaluating the potential use of pharmaceutical CBD in several additional indications, including: adult epilepsy; chemotherapy-induced peripheral neuropathy; and addiction in cocaine, amphetamines and opioids. Insys intends to pursue orphan drug designation for other indications that may qualify.

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