The United States Food and Drug Administration (FDA) announced that they have approved Insys Therapeutics to offer their CBD product as a treatment for glioma.
Glioma is a certain kind of tumor that starts in the brain or spine and Insy’s Therapeutics’ cannabidiol has been granted Orphan Drug Designation (ODD) to treat it. ODD is a status given to drugs and biologics that have been deemed safe enough to use in the diagnosis and treatment of various diseases that affect 200,000 people or less. There are exceptions to that rule however.
“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,” stated Michael Babich, President and CEO of Insys. “We believe that this product has excellent potential as a treatment for PG and look forward to advancing its development and offering a potential efficacious treatment for patients.”
Companies can apply for ODD status through their existing FDA application and must offer scientific evidence for how the drug will be beneficial in treating particular diseases. To provide the necessary confirmation, drugs will often undergo preclinical animal testing, in vitro studies, and anecdotal human experiences. Many ODD applications are denied due to lack of sufficient evidence, and this is truly significant because it means the evidence for CBD treating brain cancer is strong enough that even the FDA can no longer ignore it.
It’s a tremendous leap in the right direction, but we’re nowhere near the end of the road. While CBD alone is great, one must remember that cannabinoids typically work best when used in combination. A treatment that consisted of CBD, THC, CBN and all the other natural compounds would most likely be far more effective than just treating an ailment with CBD alone (although that does also depend on the specific disorder). It will likely be quite a while until the other components are approved, especially THC, but this FDA approval for just CBD is still huge and very promising.