Statement on the availability of cannabidiol oil

The Mississippi Legislature passed legislation in April approving the University of Mississippi Medical Center to dispense cannabidiol oil (CBD) for the treatment of epileptic seizures in children. However, major regulatory requirements still exist before patients could receive the potential treatment in a carefully controlled clinical trial.

Those requirements fall broadly into three categories. First, securing federal regulatory approval to grow the variant of low-THC, high-CBD marijuana from which the oil is extracted, and to process and transport it. Second, FDA approval for the manufacturing and clinical plan will require an investigational new drug approval. Third, a clinical trial must be initiated, with all requisite safeguards, to enroll candidate children and test the oil’s efficacy and safety.

Faculty and staff members at both the University of Mississippi and the Medical Center are moving forward on those three tracks simultaneously. For example, the National Center for Natural Products Research at the University of Mississippi School of Pharmacy has recently gained approval from two federal agencies to grow a certain quota of the particular strain.

However, many requirements remain ahead, and meeting them could take a year or more.

Anecdotal evidence suggests CBD oil may be effective for intractable epilepsy in children. However, rigorous and formal research studies in humans must be conducted to establish the oil’s effectiveness and safety.

Any such clinical trial established at UMMC would initially involve children with refractory or more serious types of epilepsy. There are no current plans to study the effectiveness of CBD oil or smoked marijuana on seizure activity in adults. Nor do neurologists at UMMC believe that smoked marijuana—whether medical or recreational—currently has a place in treating epilepsy.

The regulatory requirements for the growth, production and use of CBD oil, and the safety measures involved in establishing a clinical trial, are significant and in place for good reason.

We understand the urgency and immediate need for improved treatments and are moving forward with that motivation. At the same time, our efforts are balanced by extensive measures to ensure care, safety, compliance with current laws and the protection of patients.

If and when regulatory requirements are met and clinical trial setup is complete, enrollment of appropriate patients will begin.