Clinical Trials on CBD and Epilepsy Finally Preparing to Begin in Mississippi
Due to federal interference, a clinical trial receiving FDA approval to look at cannabidiol as a treatment for seizure disorders is late to the game. Earlier this year GW Pharmacueticals, a British pharmaceutical company, became the first to submit clinical trial information to the United States Food and Drug Administration for review – not surprising to many of us their new medicine, Epidiolex, was approved for use in two types of severe seizure conditions.
Now, only after CBD has been proven once to be successful in the treatment of seizures – and four years after Harper Grace’s Law was passed in Mississippi – will a clinical trial of a marijuana-derived medicine take place at the University of Mississippi Medical Center.
“So you can imagine we’ve had many regulatory hurdles to get here today … in order to provide such unique opportunities for our patients,” said Richard Summers, UMMC’s vice chancellor of research.
One of the biggest hurdles for anyone looking to do clinical trials on medical marijuana is the federal government – which is why a European pharmaceutical company was able to successfully complete a 4-phase clinical trial so much sooner. While we may already know what to expect out of the results however, there is no doubt that getting similar results from this trial will only further cement the fact that cannabis is a medicine.
“It is far too early for us to detail any kind of results at this point but thus far — we’re one month in on two patients and almost one month in on seven additional ones — and things are thus far going very very well. We’re very very excited about it. A real opportunity for Mississippi kids to get access to a really unique controlled product,” Ingram said.
At this point there are only nine patients enrolled in the clinical trial – however more patients are expected to be enrolled soon. It is expected that as many as 2,000 Mississippi children could qualify for this study – possibly bringing access to this medicine to these patients much sooner than they would have otherwise.