Surprise! Despite the pro-cannabis public scorn, the FDA is not as anti-cannabinoids as one may think. Contrarily, the FDA addresses the questions and pressures about CBD products readily. While there is no branded “FDA CBD drug” there has been historic progress regarding just that. The FDA is in agreement with pre-clinical trials for CBD treatment of neonatal hypoxic-ischemic encephalopathy (NHIE). Not a synthetic derivative like Marinol, a 100% pure botanical derivative CBD. As far back as 2015, intravenous CBD for infants has been on the fast track to get to market. Keep in mind, a “fast track” in the world of drug research and marketing can take many years. However, for the aching hearts of the thousands of parents every year grieving the loss of their newborn due to NHIE, final development and approval is a matter of life and death for their kids.
FDA CBD: What is NHIE?
For most, the words are completely foreign: Neonatal Hypoxic-Ischemic Encephalopathy. However, this condition affects anywhere from 6,500-12,000 newborns a year. The condition arrises during the birthing process, where the infant is cut off from oxygen due to asphyxia. Of these afflicted newborns, 1/3rd will die. Another 3rd will have developmental disorders. Right now, there is only one treatment for NHIE – inducing hypothermia in the newborn. Unfortunately, this treatment is not routinely effective, with a mortality rate and brain disorder development rate still over 25%. Since 2008, British pharmaceutical company GW Pharmaceuticals has been researching the affects of CBD on this condition in pre-clinical studies. These results are so compelling that the FDA gave CBD for NHIE classification of orphan drug.
FDA CBD: How Does CBD Help?
According to the decade of clinical and pre-clinical research regarding CBD for NHIE, CBD administration works to counteract the trauma in a few manners. Research are already studying cannabidiol’s (CBD) neuroprotective properties. In the 2008 study, researchers at began exploring if this property extends to ischemic brain damage (which NHIE causes). To their credit and the potential benefit of thousands of infants a year, the results support the hypothesis that CBD helps. Researchers are specifically referencing CBD’s anti-inflammatory and antioxidant properties as its means of neuroprotection. There are currently no effective treatments of NHIE. As such, the FDA granted 100% pure intravenous CBD orphan drug designation, allowing Phase I testing to begin.
FDA & Cannabis: A complicated relationship
This classification is rare. Orphan drugs are for rare diseases with less than 650,000 cases a year. While uncommon, this approval from the FDA shows the progression within the Federal Agency. For this reason, they must adhere to federal guidelines concerning botanical cannabis derivatives. They do, however, has guidelines for compliance across all interacting agencies, for those wishing to submit a botanical cannabis drug for FDA approval.
The FDA acknowledges the therapeutic properties of endocannabinoid treatments, and has approved multiple synthetic cannabinoids in the past. They acknowledge the unregulated market for CBD treatments for adults, kids and pets. However, they have yet to give their stamp of approval. That said, even more recently, the FDA voted to approve a CBD based epilepsy treatment, Epidiolex. Also by GW Pharmaceuticals. In this case, we are seeing this old dog, the FDA, learning some new tricks.