Insys Therapeutics announced that the U.S. Food and Drug Administration approved its unique CBD product to treat glioma – a type of tumor that originates in the brain or spine
To obtain orphan drug designation, the pharmaceutical product must generally be intended to treat a disease that affects fewer than 200,000 people, although there are exceptions. Companies can apply for approval via an FDA application. Part of this application includes a discussion of the scientific rationale as to why the drug could benefit the intended disease. Acceptable evidence includes in vitro studies, pre-clinical animal testing, and any relevant human experience. If the justification is not sufficiently strong, the FDA would reasonably deny the application.
Orphan Drug Designation for CBD
The fact that the FDA has approved for a CBD product to treat glioma is remarkably significant. This means that the US government believes that the scientific evidence is strong enough to justify the direct treatment of brain cancer in humans with a cannabinoid. They would simply have rejected the application if there were no tangible substance, but such approval expressly implies real therapeutic potential.
These advances are impressive, but there is still much to be desired.
First of all, cannabinoids work best when used together, so treatment with CBD alone is likely to be less successful than a formula with CBD, THC, and dozens of other cannabinoids. It is also likely that the CBD used by Insys is synthetic. Although whole herbal cannabis extracts are the best, FDA approval for CBD alone is still a major milestone.
The scientific and anecdotal evidence supporting the treatment of glioma with cannabis is fairly strong
Dr. Manuel Guzman of Spain is well known for his study showing how THC induces programmed cell death in glioma cells. CBD has also been shown to kill several types of glioma cell lines, in addition to inhibiting migration, proliferation, growth, invasion, and angiogenesis. With such powerful properties, it is not surprising that anecdotal evidence is favorable.
Sophie Ryan, an optic glioma patient, was featured in O’Shaughnessy’s journal with startling documentation of the anticancer effects of cannabinoids (THC and CBD) against her tumor. While she was also undergoing chemotherapy, traditional treatment was only intended to stabilize the tumor, not shrink it. Another observational study in the same journal documented an optic glioma shrinking by more than 95% in 16 months; in this case, cannabis oil was the only treatment.
Cannabis should be made available to cancer patients
For years, many other people have reported incredible success against brain cancer with cannabis oil. It is undeniable that it works, at least in some cases.
Our work shows that CBD has the potential to provide an effective and synergistic treatment option for glioblastoma and should continue to be rigorously studied.
Because of this reality, cannabis extracts should be made available to any brain cancer patient who so wishes and clinical tests should begin immediately to optimize cannabis treatment.
UPDATE: It is important to note that Insys is also evaluating the potential use of pharmaceutical CBD in several additional indications, including adult epilepsy; chemotherapy-induced peripheral neuropathy; and cocaine, amphetamine, and opioid dependence.