Insys Therapeutics Gets FDA Orphan Drug Designation For Pharma Cannabidiol

(RTTNews) - Insys Therapeutics Inc. (INSY) announced that the U.S. Food and Drug Administration has granted orphan drug designation or ODD to its pharmaceutical cannabidiol or CBD for the treatment of glioblastoma multiforme or GBM, the most common and most aggressive malignant primary brain tumor in humans.

In addition to receiving ODD, Insys has recently entered into an exclusive licensing agreement with California Pacific Medical Center on behalf of its Research Institute (CPMCRI) based in San Francisco to license CPMCRI's patent rights related to the usage of cannabinoids for the treatment of GBM.

In concert with the exclusive licensing agreement, Insys is collaborating with Dr. Sean McAllister at CPMCRI with respect to his pre-clinical research focusing on the ability of CBD to sensitize GBM to current standard of care chemotherapy treatment.

Insys, which has more than seven years of research and development experience in the pharmaceutical cannabinoid space, manufactures pharmaceutical dronabinol (THC) and pharmaceutical CBD, both of which are cannabinoids, at its FDA-inspected and Drug Enforcement Administration (DEA) approved facility, located in Round Rock, Texas.

The company recently submitted a Drug Master File 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.

Previously, Insys was granted ODD to its pharmaceutical CBD for the treatment of Lennox-Gastaut Syndrome and Dravet Syndrome, both rare forms of epilepsy. Insys said it 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.

Glioblastoma multiforme (GBM) is the most common class of malignant primary brain tumors and one of the most aggressive forms of cancer. The aggressive behavior of GBM is secondary to its high invasiveness and proliferation rate as well as to its high resistance to standard chemotherapy and radiotherapy.