FDA Approves Epidiolex and Emphasizes Scientific Research on Cannabis 

In a twist of events that didn’t surprise cannabis advocates, the U.S. Food and Drug Administration announced that marijuana does indeed have legitimate medical applications. This take goes against the federal drug classification system that places marijuana in the Schedule I controlled substance category. Schedule I controlled substances are drugs with no accepted medical use that have a high potential for abuse.

There are numerous studies and anecdotal evidence that support the conclusion that cannabis can help treat a range of medical conditions, from post-traumatic stress disorder to chronic pain, anxiety, insomnia, and multiple sclerosis, among others. In an FDA first, the government organization admits that there is an increasing interest in the potential of exploring the reported benefits of medicinal cannabis. It has also approved one cannabis-based medication for use in the U.S. to help treat seizures in those with particular epileptic medical conditions.

It is a step in the right direction. Still, the FDA admits that more scientific research is needed to unlock the full range of potential health effects and medicinal benefits of marijuana.

What Is Epidiolex?

Epidiolex is the first cannabis-based medication approved by the U.S. Food and Drug Administration to treat seizures associated with specific epileptic medical disorders such as Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex. Epidiolex is a cannabidiol or CBD oral solution that has been shown to help reduce seizures in some epileptic patients as young as one year of age.

Epilepsy is a neurological brain disorder. In patients with epileptic conditions, the electrical network in the brain malfunctions. In healthy individuals, the brain regularly generates electrical impulses that travel along neurons or specialized nerve cells. In patients with epileptic medical conditions, these electrical signals are imbalanced and irregular, which can result in seizures. Seizures are sudden and temporary bursts of abnormal electrical brain activity that change or disrupt the messages between brain cells. This electrical activity can cause loss of consciousness, erratic muscle movements, and changes in sensation and sensory perception.

Clinical studies show that the cannabidiol drug Epidiolex can significantly reduce the number of seizures some patients experience, improving their quality of life, especially in patients suffering specific pediatric epileptic conditions. Research suggests that CBD, one of the leading non-psychoactive chemical components of marijuana, blocks specific signals carried by a molecule in the brain called lysophosphatidylinositol or LPI. LPI may be responsible for weakening signals in the brain that counter seizure activity. When LPI signals get blocked, they cannot amplify nerve signals in an area of the brain called the hippocampus. Researchers suggest that CBD blocks the positive feedback loop where seizure activity increases specific LPI signals, which, in turn, encourages more seizures, which then increases LPI.

While Epidiolex is the only cannabis-based drug approved by the FDA, the administration has also approved three synthetic cannabis-related medications, including Marinol, Syndros, and Cesamet. Marinol and Syndros have been approved to treat nausea associated with chemotherapy treatment in cancer patients. The synthetic cannabis compound is similar in chemical structure to THC, the primary psychoactive compound found in marijuana.

These drugs can also treat patients with anorexia and AIDs because they help increase and stimulate appetite, a side effect cannabis enthusiasts have known about for decades. Cesamet is another drug approved for treating nausea associated with chemotherapy treatment, but it contains a different synthetic active ingredient that mimics THC.

A Shift in Medical Marijuana Perception

In a statement, the U.S. Food and Drug Administration says it understands the need to continue to research and develop beneficial therapies for patients, and this statement includes cannabis-based therapies in that category. The organization is committed to facilitating the process with Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval programs. These programs help the FDA develop and expedite the process of approving therapeutic drug products for patients in the United States.

The FDA’s statement also indicates that the government agency wants to help facilitate clinical research and studies that investigate the benefits, side effects, and health implications of medicinal cannabis. The agency hopes it can help open scientific doors to researchers by providing necessary information on the process for conducting clinical research involving cannabis, providing information on specific requirements needed to develop a drug suitable for humans, and providing general support to researchers and investigators.

Until states started legalizing medicinal and recreational cannabis possession and consumption, it was tough for legitimate scientific researchers to conduct studies on cannabis and its chemical compounds. State and federal regulations and policies significantly restricted scientific access to cannabis products. Researchers regularly found themselves stumbling through complicated regulatory barriers, challenges accessing cannabis supplies, and significant funding limitations.

As states expanded medical and recreational cannabis policy, it became easier for scientific researchers to conduct legitimate research and clinical studies. However, with greater support from a federal agency like the FDA, scientific research, especially in jurisdictions without robust cannabis reform policies, may advance by leaps and bounds, expanding our understanding of this complex plant.

Subtle Push for Action

The FDA report stating that cannabis does indeed have legitimate medical applications may also be a subtle (or not-so-subtle) dig at the U.S. Drug Enforcement Agency. Currently, the DEA is considering a recommendation from the U.S. Department of Health and Human Services to reschedule marijuana from a Schedule I controlled substance down to a Schedule III substance. The Department of Health and Human Services compiled and turned over to the DEA extensive clinical studies and documentation outlining the benefits of cannabis.

With a statement from the FDA reiterating the medicinal and therapeutic benefits of cannabis, it becomes that much harder for the DEA to argue that marijuana meets the strict guidelines for being classified as a Schedule I substance. However, the DEA has made it crystal clear that they alone hold jurisdiction over the classification of drugs and must review all clinical, social, and criminal justice implications of rescheduling marijuana before making a decision.

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