July 20 (UPI) -- A "concussion pill" under development in Miami using cannabis is showing progress for treatment of traumatic brain injuries.
In a pre-clinical study, the combination of a hemp-derived cannabinoid and an NMDA amino acid anesthetic is showing improved cognitive function in rodents with traumatic brain injuries compared with individual components.
The project is a joint collaboration with the University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis and Scythian Biosciences Corp. of Toronto.
"The results were statistically significant and encouraging," Scythian's Jonathan Gilbert, who manages the University of Miami partnership, told UPI. "This evidence strongly suggests further testing is warranted on medical cannabis' potential in the treatment of trauma to the brain."
Scythian, a pre-clinical research and development company developing drug therapies, gave a $16 million grant to the university in 2016. Scythian is attempting to be the front-runner in the medical marijuana industry, including developing the first accepted drug regimen for the treatment of concussion.
"The potential is enormous and extraordinary," Gilbert said. "It may someday be mandatory equipment on the sidelines of every football, baseball and soccer game, from youth leagues to professional organizations, ready to protect people of all ages from the brain's immediate inflammatory response to trauma. It could also become standard treatment in emergency rooms and ambulances so first responders can administer it to patients within the 'golden hour' after an injury: a critical window of opportunity."
In the pre-clinical study, there were no adverse effects from the combination therapy or the individual components.
"There needs to be more systematic research in this field in order to study the neuroprotective properties of CBD, and to improve treatment for those sustaining mild to moderate traumatic brain injury and concussion," Dr. Gillian A. Hotz, professor of neurological surgery, and director of the KiDZ Neuroscience Center at The Miami Project and the UM Sports Medicine Institute concussion program, said in a press release.
In Phase 2 research, a few humans will likely be administered the compounds in pill form to a control group and two groups of TBI patients, acute and chronic.
The third phase will be a full-scale clinical trial over the next three years if the treatment is determined to be deemed safe and effective. The researchers plans to study the effectiveness in other injury models.
Then it would need to be evaluated by the U.S. Food and Drug Administration as an effective therapeutic treatment for those suffering from severities of TBI and concussion.
In June, the FDA approved for the first time a drug derived from marijuana -- to treat epilepsy -- as well as its first medication of any kind for Dravet syndrome. Epidiolex was approved for the treatment of seizures associated with two rare and severe forms of epilepsy -- Lennox-Gastaut syndrome and Dravet syndrome.
"The implications for the study are extraordinary," Dr. Michael Hoffer, director of the Vestibular and Balance Program in Miami's Department of Otolaryngology, said. "Having such a large, multidisciplinary team of neuroscience experts attaching themselves to research that could change the outcome of TBI and concussion care is the opportunity researchers have been looking for to curb the growing trend of concussion."
Besides athletes getting concussions, there have been 370,688 traumatic brain injuries diagnosed among U.S. military members from 2000 to 2017, according to Defense and Veterans Brain Injury Center. Among those cases, 305,140 were listed as mild.
Short-term effects of concussions include headaches and dizziness, as well as an increased risk for longer-term chronic medical problems, including disorders of attention, memory, anxiety, depression and dementia.
"One thing has eluded us -- a clinically proven medication to treat concussion," Hotz said. "Whether or not this study leads to a pill that could treat concussion, this type of research will pave the way for UM and other researchers to better manage concussion. It's a privilege to help lead this journey."
Gilbert said the treatment likely will be in pill form.
"The University of Miami believes it will be a pill, however we are open to any type of delivery method -- a strip, ingestion through the nose, intravenous uptake, etc," he said. "Though we don't have confirmation on the treatment's delivery method, we are working under the assumption that it is going to be a pill."