FDA grants orphan drug status to cannabidiol for glioblastoma multiforme

Insys Therapeutics recently announced that the FDA has granted orphan drug designation to a pharmaceutical cannabidiol for the treatment of glioblastoma multiforme.

“We are pleased to have received orphan drug designation for this aggressive and often incurable form of brain cancer. We look forward to advancing development of this product and offering a potential efficacious treatment for patients,” Michael L. Babich, president and CEO of Insys Therapeutics, said in a press release.

The FDA based its decision in part on preclinical research that indicates the ability of cannabidiol to condition glioblastoma multiforme to current standard of care chemotherapy treatment.

Besides receiving orphan drug designation, Insys recently entered into an exclusive licensing agreement with the California Pacific Medical Center Research Institute (CPMCRI) to license its patent rights related to the usage of cannabinoids for the treatment of glioblastoma multiforme, according to the release.

“Based on previous research conducted with [cannabidiol] to treat brain tumors, we believe that there is supportive evidence for the use of [cannabidiol] as an adjunct treatment in [glioblastoma multiforme] and eagerly anticipate the results from our in vivo models to further support clinical studies in humans,” researcher Sean D. McAllister, PhD, of the California Pacific Medical Center Research Institute, said in the release.

Insys is currently assessing the prospective use of its pharmaceutical cannabidiol for other conditions, including adult epilepsy, chemotherapy-induced peripheral neuropathy, as well as addiction to amphetamines, cocaine and opioids.