The FDA understands that there is increasing interest
In October 2019, Former FDA (The Food and Drug Administration) Commissioner Scott Gottlieb, MD, publicly shared his opinion by saying, “We should make it easier to get medical Cannabis and treat it the same way we treat drugs.” FDA has already approved one drug that contains compounds derived from Cannabis. “These drugs have important therapeutic value, and we must continue to do what we can to support the science needed to develop new drugs from Cannabis,” emphasized Dr.Sharpless at the FDA public hearing earlier this year. There is a lack of research and clinical evidence to support numerous claims regarding CBD oil and CBD -oil-related products. Not because the CBD or THC efficiency is lacking, au contaire, we have many unanswered questions because hemp, Cannabis, and marijuana were on controlled substances list for very long. Regulatory barriers were hampering the research. Finally, hemp had been removed from the controlled substance list on December 20, 2018.
Medical Cannabis can be administered as capsules, tablets, tinctures, dermal patches, oral or dermal sprays, edibles, and dried buds can be smoked or vaped. Countries that allow the medical use of Cannabis include Australia, Canada, Chile, Colombia, Germany, Greece, Israel, Italy, the Netherlands, Peru, Poland, Portugal, and Uruguay.
More research is required for Cannabis-derived drugs
Epidiolex® is approved by the FDA to treat rare types of schizophrenia for children over two years old and adults. Epidiolex® is a purified CBD oil and is derived directly from plant Cannabis. GW Pharmaceuticals that manufactures Epidiolex® had recently published updated the phase 3 clinical study results presented on Annual Metting of American Epilepsy Society. Caregivers and patients reported overall improvement with Epidiolex® in 69% of patients. The plan is to apply for FDA approval in 2019 for Seizures Associated With Tuberous Sclerosis Complex.
Sativex® is an oral spray also manufactured by GW Pharmaceuticals; it contains a 1:1 cannabis-derived mixture of THC/CBD. An investigational product in the US, but the company is planning to seek FDA-approval as well. Sativex® is already approved in more than 25 countries for the treatment of spasticity due to multiple sclerosis.
The FDA previously approved synthetic cannabis-related drug products: Marinol®, Syndros®, and Cesamet®.
In December 2019, the FDA affirmed growing interest in researching the potential of Cannabis in treating multiple conditions. The agency is supporting sound scientific research for Cannabis-derived products such as CBD ( less than 0.3% THC on a dry weight basis) and THC/CBD cannabis products (higher than 0.3% THC on a dry weight basis). One hundred fifty-five active and launching clinical studies are listed on www.clinicaltrials.gov as of the end of 2019.
The lack of knowledge about the potential side effect is a concern for FDA, Scott Gottlieb mentioned: “there is some evidence of impairment of executive function and short term memory in young adults and the expecting mothers”.
In 2020, the main focus is to stay realistic as with any drug we use and keep improving the risk/benefit profile of cannabis-derived medicines.